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Educating teens, young adults about dangers of vaping
Physicians have been alarmed about the vaping craze for quite some time. This alarm has grown louder in the wake of news that electronic cigarettes have been associated with a mysterious lung disease.
Public health officials have reported that there have been 530 cases of vaping-related respiratory disease,1 and as of press time at least seven deaths had been attributed to vaping*. On Sept. 6, 2019, the Food and Drug Administration, Centers for Disease Control and Prevention, and other health officials issued an investigation notice on vaping and e-cigarettes,2 cautioning teenagers, young adults, and pregnant women to avoid e-cigarettes completely and cautioning all users to never buy e-cigarettes off the street or from social sources.
A few days later, on Sept. 9, the FDA’s Center for Tobacco Products issued a warning letter to JUUL Labs, makers of a popular e-cigarette, for illegal marketing of modified-risk tobacco products.3 Then on Sept. 10, health officials in Kansas reported that a sixth person has died of a lung illness related to vaping.4
Researchers have found that 80% of those diagnosed with the vaping illness used products that contained THC, the psychoactive ingredient in marijuana, 61% had used nicotine products, and 7% used cannabidiol (CBD) products. Vitamin E acetate is another substance identified in press reports as tied to the severe lung disease.
Most of the patients affected are adolescents and young adults, with the average age of 19 years.5 This comes as vaping among high school students rose 78% between 2017 and 2018.6 According the U.S. surgeon general, one in five teens vapes. Other data show that teen use of e-cigarettes comes with most users having never smoked a traditional cigarette.7 Teens and young adults frequently borrow buy* e-cigarette “pods” from gas stations but borrow and purchase from friends or peers. In addition, young people are known to alter the pods to insert other liquids, such as CBD and other marijuana products.
Teens and young adults are at higher risk for vaping complications. Their respiratory and immune systems are still developing. In addition to concerns about the recent surge of respiratory illnesses, nicotine is known to also suppress the immune system, which makes people who use it more susceptible to viral and bacterial infections – and also making it harder for them to recover.
In addition nicotine hyperactivates the reward centers of the brain, which can trigger addictive behaviors. Because the brains of young adults are not yet fully developed until at or after age 26, nicotine use before this can “prime the pump” of a still-developing brain, thereby increasing the likelihood for addiction to harder drugs. Nicotine has been shown to disrupt sleep patterns, which are critical for mental and physical health. Lastly, research shows that smoking increases the risks of various psychiatric disorders, such as depression and anxiety. My teen and young adult patients have endlessly debated with me the idea that smoking – either nicotine or marijuana – eases their anxiety or helps them get to sleep. I tell them that, in the long run, the data show that smoking makes those problems worse.8-11
Nationally, we are seeing an explosion of multistate legislation pushing marijuana as a health food. E-cigarettes have followed as the “healthy” alternative to traditional tobacco. As clinicians, we must counter those messages.
Finally, our world is now filled with smartphones, sexting, and social media overuse. An entire peer group exists that knows life only with constant electronic stimulation. It is not without irony that our national nicotine obsessions have morphed from paper cigarettes to electronic versions. This raises questions: Are teens and young adults using e-cigarettes because of boredom? Are we witnessing a generational ADHD borne from restlessness that stems from lives with fewer meaningful face-to-face human interactions?
In addition to educating our teens and young adults about the physical risks tied to vaping, we need to teach them to build meaning into their lives that exists outside of this digital age.
Dr. Jorandby is chief medical officer of Lakeview Health in Jacksonville, Fla. She trained in addiction psychiatry at Yale University, New Haven, Conn.
References
1. CDC. Outbreak of lung injury associated with e-cigarette use, or vaping. 2019 Sep 19.
2. CDC. Outbreak of lung illness associated with using e-cigarette products. Investigation notice. 2019 Sep 6.
3. FDA. Warning letter, JUUL Labs. 2019 Sep 9.
4. Sixth person dies of vaping-related illness. The Hill. 2019 Sep 10.
5. Layden JE. Pulmonary illness related to cigarette use in Illinois and Wisconsin – preliminary report. N Engl J Med. 2019 Sep 6. doi: 10.1056/NEJMoa1911614.
6. Cullen KA et al. CDC. MMWR. 2018 Nov 16;67(45):1276-7.
7. National Academies of Sciences, Engineering, and Medicine. Public health consequences of e-cigarettes. 2018.
8. Patton GC et al. Am J Public Health. 1996 Feb;86(2):225-30.
9. Leventhal AM et al. J Psychiatr Res. 2016 Feb;73:71-8.
10. Levine A et al. J Am Acad Child Adolesc Psychiatry. 2017 Mar;56(3):214-2.
11. Leadbeater BJ et al. Addiction. 2019 Feb;114(2):278-93.
* This column was updated 9/24/2019.
Physicians have been alarmed about the vaping craze for quite some time. This alarm has grown louder in the wake of news that electronic cigarettes have been associated with a mysterious lung disease.
Public health officials have reported that there have been 530 cases of vaping-related respiratory disease,1 and as of press time at least seven deaths had been attributed to vaping*. On Sept. 6, 2019, the Food and Drug Administration, Centers for Disease Control and Prevention, and other health officials issued an investigation notice on vaping and e-cigarettes,2 cautioning teenagers, young adults, and pregnant women to avoid e-cigarettes completely and cautioning all users to never buy e-cigarettes off the street or from social sources.
A few days later, on Sept. 9, the FDA’s Center for Tobacco Products issued a warning letter to JUUL Labs, makers of a popular e-cigarette, for illegal marketing of modified-risk tobacco products.3 Then on Sept. 10, health officials in Kansas reported that a sixth person has died of a lung illness related to vaping.4
Researchers have found that 80% of those diagnosed with the vaping illness used products that contained THC, the psychoactive ingredient in marijuana, 61% had used nicotine products, and 7% used cannabidiol (CBD) products. Vitamin E acetate is another substance identified in press reports as tied to the severe lung disease.
Most of the patients affected are adolescents and young adults, with the average age of 19 years.5 This comes as vaping among high school students rose 78% between 2017 and 2018.6 According the U.S. surgeon general, one in five teens vapes. Other data show that teen use of e-cigarettes comes with most users having never smoked a traditional cigarette.7 Teens and young adults frequently borrow buy* e-cigarette “pods” from gas stations but borrow and purchase from friends or peers. In addition, young people are known to alter the pods to insert other liquids, such as CBD and other marijuana products.
Teens and young adults are at higher risk for vaping complications. Their respiratory and immune systems are still developing. In addition to concerns about the recent surge of respiratory illnesses, nicotine is known to also suppress the immune system, which makes people who use it more susceptible to viral and bacterial infections – and also making it harder for them to recover.
In addition nicotine hyperactivates the reward centers of the brain, which can trigger addictive behaviors. Because the brains of young adults are not yet fully developed until at or after age 26, nicotine use before this can “prime the pump” of a still-developing brain, thereby increasing the likelihood for addiction to harder drugs. Nicotine has been shown to disrupt sleep patterns, which are critical for mental and physical health. Lastly, research shows that smoking increases the risks of various psychiatric disorders, such as depression and anxiety. My teen and young adult patients have endlessly debated with me the idea that smoking – either nicotine or marijuana – eases their anxiety or helps them get to sleep. I tell them that, in the long run, the data show that smoking makes those problems worse.8-11
Nationally, we are seeing an explosion of multistate legislation pushing marijuana as a health food. E-cigarettes have followed as the “healthy” alternative to traditional tobacco. As clinicians, we must counter those messages.
Finally, our world is now filled with smartphones, sexting, and social media overuse. An entire peer group exists that knows life only with constant electronic stimulation. It is not without irony that our national nicotine obsessions have morphed from paper cigarettes to electronic versions. This raises questions: Are teens and young adults using e-cigarettes because of boredom? Are we witnessing a generational ADHD borne from restlessness that stems from lives with fewer meaningful face-to-face human interactions?
In addition to educating our teens and young adults about the physical risks tied to vaping, we need to teach them to build meaning into their lives that exists outside of this digital age.
Dr. Jorandby is chief medical officer of Lakeview Health in Jacksonville, Fla. She trained in addiction psychiatry at Yale University, New Haven, Conn.
References
1. CDC. Outbreak of lung injury associated with e-cigarette use, or vaping. 2019 Sep 19.
2. CDC. Outbreak of lung illness associated with using e-cigarette products. Investigation notice. 2019 Sep 6.
3. FDA. Warning letter, JUUL Labs. 2019 Sep 9.
4. Sixth person dies of vaping-related illness. The Hill. 2019 Sep 10.
5. Layden JE. Pulmonary illness related to cigarette use in Illinois and Wisconsin – preliminary report. N Engl J Med. 2019 Sep 6. doi: 10.1056/NEJMoa1911614.
6. Cullen KA et al. CDC. MMWR. 2018 Nov 16;67(45):1276-7.
7. National Academies of Sciences, Engineering, and Medicine. Public health consequences of e-cigarettes. 2018.
8. Patton GC et al. Am J Public Health. 1996 Feb;86(2):225-30.
9. Leventhal AM et al. J Psychiatr Res. 2016 Feb;73:71-8.
10. Levine A et al. J Am Acad Child Adolesc Psychiatry. 2017 Mar;56(3):214-2.
11. Leadbeater BJ et al. Addiction. 2019 Feb;114(2):278-93.
* This column was updated 9/24/2019.
Physicians have been alarmed about the vaping craze for quite some time. This alarm has grown louder in the wake of news that electronic cigarettes have been associated with a mysterious lung disease.
Public health officials have reported that there have been 530 cases of vaping-related respiratory disease,1 and as of press time at least seven deaths had been attributed to vaping*. On Sept. 6, 2019, the Food and Drug Administration, Centers for Disease Control and Prevention, and other health officials issued an investigation notice on vaping and e-cigarettes,2 cautioning teenagers, young adults, and pregnant women to avoid e-cigarettes completely and cautioning all users to never buy e-cigarettes off the street or from social sources.
A few days later, on Sept. 9, the FDA’s Center for Tobacco Products issued a warning letter to JUUL Labs, makers of a popular e-cigarette, for illegal marketing of modified-risk tobacco products.3 Then on Sept. 10, health officials in Kansas reported that a sixth person has died of a lung illness related to vaping.4
Researchers have found that 80% of those diagnosed with the vaping illness used products that contained THC, the psychoactive ingredient in marijuana, 61% had used nicotine products, and 7% used cannabidiol (CBD) products. Vitamin E acetate is another substance identified in press reports as tied to the severe lung disease.
Most of the patients affected are adolescents and young adults, with the average age of 19 years.5 This comes as vaping among high school students rose 78% between 2017 and 2018.6 According the U.S. surgeon general, one in five teens vapes. Other data show that teen use of e-cigarettes comes with most users having never smoked a traditional cigarette.7 Teens and young adults frequently borrow buy* e-cigarette “pods” from gas stations but borrow and purchase from friends or peers. In addition, young people are known to alter the pods to insert other liquids, such as CBD and other marijuana products.
Teens and young adults are at higher risk for vaping complications. Their respiratory and immune systems are still developing. In addition to concerns about the recent surge of respiratory illnesses, nicotine is known to also suppress the immune system, which makes people who use it more susceptible to viral and bacterial infections – and also making it harder for them to recover.
In addition nicotine hyperactivates the reward centers of the brain, which can trigger addictive behaviors. Because the brains of young adults are not yet fully developed until at or after age 26, nicotine use before this can “prime the pump” of a still-developing brain, thereby increasing the likelihood for addiction to harder drugs. Nicotine has been shown to disrupt sleep patterns, which are critical for mental and physical health. Lastly, research shows that smoking increases the risks of various psychiatric disorders, such as depression and anxiety. My teen and young adult patients have endlessly debated with me the idea that smoking – either nicotine or marijuana – eases their anxiety or helps them get to sleep. I tell them that, in the long run, the data show that smoking makes those problems worse.8-11
Nationally, we are seeing an explosion of multistate legislation pushing marijuana as a health food. E-cigarettes have followed as the “healthy” alternative to traditional tobacco. As clinicians, we must counter those messages.
Finally, our world is now filled with smartphones, sexting, and social media overuse. An entire peer group exists that knows life only with constant electronic stimulation. It is not without irony that our national nicotine obsessions have morphed from paper cigarettes to electronic versions. This raises questions: Are teens and young adults using e-cigarettes because of boredom? Are we witnessing a generational ADHD borne from restlessness that stems from lives with fewer meaningful face-to-face human interactions?
In addition to educating our teens and young adults about the physical risks tied to vaping, we need to teach them to build meaning into their lives that exists outside of this digital age.
Dr. Jorandby is chief medical officer of Lakeview Health in Jacksonville, Fla. She trained in addiction psychiatry at Yale University, New Haven, Conn.
References
1. CDC. Outbreak of lung injury associated with e-cigarette use, or vaping. 2019 Sep 19.
2. CDC. Outbreak of lung illness associated with using e-cigarette products. Investigation notice. 2019 Sep 6.
3. FDA. Warning letter, JUUL Labs. 2019 Sep 9.
4. Sixth person dies of vaping-related illness. The Hill. 2019 Sep 10.
5. Layden JE. Pulmonary illness related to cigarette use in Illinois and Wisconsin – preliminary report. N Engl J Med. 2019 Sep 6. doi: 10.1056/NEJMoa1911614.
6. Cullen KA et al. CDC. MMWR. 2018 Nov 16;67(45):1276-7.
7. National Academies of Sciences, Engineering, and Medicine. Public health consequences of e-cigarettes. 2018.
8. Patton GC et al. Am J Public Health. 1996 Feb;86(2):225-30.
9. Leventhal AM et al. J Psychiatr Res. 2016 Feb;73:71-8.
10. Levine A et al. J Am Acad Child Adolesc Psychiatry. 2017 Mar;56(3):214-2.
11. Leadbeater BJ et al. Addiction. 2019 Feb;114(2):278-93.
* This column was updated 9/24/2019.
Michigan becomes first state to ban flavored e-cigarettes
The state health agency is expected to issue rules outlining the ban within the next 30 days. The emergency ban will be in effect for 6 months, with the possibility of a 6-month extension while state health regulators craft rules to set in place a permanent ban.
The ban will also prohibit “misleading marketing of vaping products, including the use of terms like ‘clean,’ ‘safe,’ and ‘healthy,’ that perpetuate beliefs that these products are harmless,” according to a statement issued by Gov. Whitmer.
Companies selling vaping products “are using candy flavors to hook children on nicotine and misleading claims to promote the belief that these products are safe,” she said in a statement. “That ends today. Our kids deserve leaders who are going to fight to protect them. These bold steps will finally put an end to these irresponsible and deceptive practices and protect Michiganders’ public health.”
The ban also will cover mint- and menthol-flavors in addition to sweet flavors but will not ban tobacco-flavored e-cigarette products.
The American Academy of Pediatrics, American Heart Association, American Lung Association, American Cancer Society Cancer Action Network and other organizations praised the action taken by the state, calling the steps “necessary and appropriate.”
“The need for action is even more urgent in light of the recent outbreak of severe lung illness associated with e-cigarette use and the failure of the U.S. Food and Drug Administration to take strong regulatory action such as prohibiting the sale of the flavored products nationwide that have attracted shocking numbers of our nation’s youth,” the organizations said in a statement.
The groups noted that “health authorities are investigating reports of severe respiratory illness associated with e-cigarette use in at least 215 people ... in 25 states,” adding that many are youth and young adults.
The U.S. Department of Health & Human Services Secretary Alex Azar said in an Aug. 30 statement that the federal government is “using every tool we have to get to the bottom of this deeply concerning outbreak of illness in Americans who use e-cigarettes. More broadly, we will continue using every regulatory and enforcement power we have to stop the epidemic of youth e-cigarette use.”
HHS noted that no single substance or e-cigarette product has been consistently associated with the reports of illness. The agency called upon clinicians to report any new cases as appropriate to their state and local health departments.
Gov. Whitmer earlier this year signed bills that clarify that it is illegal to sell nontraditional nicotine products to minors, but the governor’s statement notes her criticism that the bills did not go far enough to protect the state’s youth, necessitating this further action.
The state health agency is expected to issue rules outlining the ban within the next 30 days. The emergency ban will be in effect for 6 months, with the possibility of a 6-month extension while state health regulators craft rules to set in place a permanent ban.
The ban will also prohibit “misleading marketing of vaping products, including the use of terms like ‘clean,’ ‘safe,’ and ‘healthy,’ that perpetuate beliefs that these products are harmless,” according to a statement issued by Gov. Whitmer.
Companies selling vaping products “are using candy flavors to hook children on nicotine and misleading claims to promote the belief that these products are safe,” she said in a statement. “That ends today. Our kids deserve leaders who are going to fight to protect them. These bold steps will finally put an end to these irresponsible and deceptive practices and protect Michiganders’ public health.”
The ban also will cover mint- and menthol-flavors in addition to sweet flavors but will not ban tobacco-flavored e-cigarette products.
The American Academy of Pediatrics, American Heart Association, American Lung Association, American Cancer Society Cancer Action Network and other organizations praised the action taken by the state, calling the steps “necessary and appropriate.”
“The need for action is even more urgent in light of the recent outbreak of severe lung illness associated with e-cigarette use and the failure of the U.S. Food and Drug Administration to take strong regulatory action such as prohibiting the sale of the flavored products nationwide that have attracted shocking numbers of our nation’s youth,” the organizations said in a statement.
The groups noted that “health authorities are investigating reports of severe respiratory illness associated with e-cigarette use in at least 215 people ... in 25 states,” adding that many are youth and young adults.
The U.S. Department of Health & Human Services Secretary Alex Azar said in an Aug. 30 statement that the federal government is “using every tool we have to get to the bottom of this deeply concerning outbreak of illness in Americans who use e-cigarettes. More broadly, we will continue using every regulatory and enforcement power we have to stop the epidemic of youth e-cigarette use.”
HHS noted that no single substance or e-cigarette product has been consistently associated with the reports of illness. The agency called upon clinicians to report any new cases as appropriate to their state and local health departments.
Gov. Whitmer earlier this year signed bills that clarify that it is illegal to sell nontraditional nicotine products to minors, but the governor’s statement notes her criticism that the bills did not go far enough to protect the state’s youth, necessitating this further action.
The state health agency is expected to issue rules outlining the ban within the next 30 days. The emergency ban will be in effect for 6 months, with the possibility of a 6-month extension while state health regulators craft rules to set in place a permanent ban.
The ban will also prohibit “misleading marketing of vaping products, including the use of terms like ‘clean,’ ‘safe,’ and ‘healthy,’ that perpetuate beliefs that these products are harmless,” according to a statement issued by Gov. Whitmer.
Companies selling vaping products “are using candy flavors to hook children on nicotine and misleading claims to promote the belief that these products are safe,” she said in a statement. “That ends today. Our kids deserve leaders who are going to fight to protect them. These bold steps will finally put an end to these irresponsible and deceptive practices and protect Michiganders’ public health.”
The ban also will cover mint- and menthol-flavors in addition to sweet flavors but will not ban tobacco-flavored e-cigarette products.
The American Academy of Pediatrics, American Heart Association, American Lung Association, American Cancer Society Cancer Action Network and other organizations praised the action taken by the state, calling the steps “necessary and appropriate.”
“The need for action is even more urgent in light of the recent outbreak of severe lung illness associated with e-cigarette use and the failure of the U.S. Food and Drug Administration to take strong regulatory action such as prohibiting the sale of the flavored products nationwide that have attracted shocking numbers of our nation’s youth,” the organizations said in a statement.
The groups noted that “health authorities are investigating reports of severe respiratory illness associated with e-cigarette use in at least 215 people ... in 25 states,” adding that many are youth and young adults.
The U.S. Department of Health & Human Services Secretary Alex Azar said in an Aug. 30 statement that the federal government is “using every tool we have to get to the bottom of this deeply concerning outbreak of illness in Americans who use e-cigarettes. More broadly, we will continue using every regulatory and enforcement power we have to stop the epidemic of youth e-cigarette use.”
HHS noted that no single substance or e-cigarette product has been consistently associated with the reports of illness. The agency called upon clinicians to report any new cases as appropriate to their state and local health departments.
Gov. Whitmer earlier this year signed bills that clarify that it is illegal to sell nontraditional nicotine products to minors, but the governor’s statement notes her criticism that the bills did not go far enough to protect the state’s youth, necessitating this further action.
MenB vaccination coverage higher in those receiving MenB-4C
While meningococcal group B (MenB) vaccination remains suboptimal in the United States, completion was significantly higher for the MenB-4C (Bexsero) vaccine, compared with the other vaccine option, MenB-FHbp (Trumenba), according to Elizabeth Packnett of IBM Watson Health in Bethesda, Md., and associates.
In a study published in Vaccine, the investigators retrospectively analyzed 65,205 (36,118 received MenB-4C; 29,087 received MenB-FHbp) commercially insured individuals from the MarketScan Commercial Claims and Encounters Database during Jan. 1, 2015–Feb. 28, 2018, as well as 13,535 (10,153 received MenB-4C; 3,382 received MenB-FHbp) Medicaid-covered individuals from the Medicaid Multi-State Database during Jan. 1, 2015–Dec. 31, 2017.
The rate of vaccine completion in the MarketScan database within 15 months of initiation was 63% for MenB-4C and 52% for MenB-FHbp, and dosing schedule adherence was 62% for MenB-4C and 18% for MenB-FHbp. The median time to completion among those who finished vaccination was 68 days for MenB-4C versus 258 days for MenB-FHbp.
In the Medicaid database, the rate of vaccine completion within 15 months of initiation was 49% for MenB-4C and 31% for MenB-FHbp; dosing schedule adherence was 48% and 8%, respectively. Median time to vaccine completion was 88 days for MenB-4C versus 309 days for MenB-FHbp.
“The observations of improved completion and schedule adherence rates for MenB-4C, compared with MenB-FHbp, were consistent across both the commercial and Medicaid populations, and persisted after adjusting for individual factors in multivariable analyses, suggesting that the results were not skewed by population differences in demographic or other characteristics,” the investigators noted, adding that the significant difference in completion and schedule adherence between vaccines likely reflects the MenB-4C flexible dosing schedule.
The study was funded by GlaxoSmithKline, the maker of MenB-4C, and four coauthors reported being employed by the company. Five coauthors were employed by IBM Watson Health, which conducted the study.
SOURCE: Packnett E et al. Vaccine. 2019 Aug 20. doi: 10.1016/j.vaccine.2019.06.065.
While meningococcal group B (MenB) vaccination remains suboptimal in the United States, completion was significantly higher for the MenB-4C (Bexsero) vaccine, compared with the other vaccine option, MenB-FHbp (Trumenba), according to Elizabeth Packnett of IBM Watson Health in Bethesda, Md., and associates.
In a study published in Vaccine, the investigators retrospectively analyzed 65,205 (36,118 received MenB-4C; 29,087 received MenB-FHbp) commercially insured individuals from the MarketScan Commercial Claims and Encounters Database during Jan. 1, 2015–Feb. 28, 2018, as well as 13,535 (10,153 received MenB-4C; 3,382 received MenB-FHbp) Medicaid-covered individuals from the Medicaid Multi-State Database during Jan. 1, 2015–Dec. 31, 2017.
The rate of vaccine completion in the MarketScan database within 15 months of initiation was 63% for MenB-4C and 52% for MenB-FHbp, and dosing schedule adherence was 62% for MenB-4C and 18% for MenB-FHbp. The median time to completion among those who finished vaccination was 68 days for MenB-4C versus 258 days for MenB-FHbp.
In the Medicaid database, the rate of vaccine completion within 15 months of initiation was 49% for MenB-4C and 31% for MenB-FHbp; dosing schedule adherence was 48% and 8%, respectively. Median time to vaccine completion was 88 days for MenB-4C versus 309 days for MenB-FHbp.
“The observations of improved completion and schedule adherence rates for MenB-4C, compared with MenB-FHbp, were consistent across both the commercial and Medicaid populations, and persisted after adjusting for individual factors in multivariable analyses, suggesting that the results were not skewed by population differences in demographic or other characteristics,” the investigators noted, adding that the significant difference in completion and schedule adherence between vaccines likely reflects the MenB-4C flexible dosing schedule.
The study was funded by GlaxoSmithKline, the maker of MenB-4C, and four coauthors reported being employed by the company. Five coauthors were employed by IBM Watson Health, which conducted the study.
SOURCE: Packnett E et al. Vaccine. 2019 Aug 20. doi: 10.1016/j.vaccine.2019.06.065.
While meningococcal group B (MenB) vaccination remains suboptimal in the United States, completion was significantly higher for the MenB-4C (Bexsero) vaccine, compared with the other vaccine option, MenB-FHbp (Trumenba), according to Elizabeth Packnett of IBM Watson Health in Bethesda, Md., and associates.
In a study published in Vaccine, the investigators retrospectively analyzed 65,205 (36,118 received MenB-4C; 29,087 received MenB-FHbp) commercially insured individuals from the MarketScan Commercial Claims and Encounters Database during Jan. 1, 2015–Feb. 28, 2018, as well as 13,535 (10,153 received MenB-4C; 3,382 received MenB-FHbp) Medicaid-covered individuals from the Medicaid Multi-State Database during Jan. 1, 2015–Dec. 31, 2017.
The rate of vaccine completion in the MarketScan database within 15 months of initiation was 63% for MenB-4C and 52% for MenB-FHbp, and dosing schedule adherence was 62% for MenB-4C and 18% for MenB-FHbp. The median time to completion among those who finished vaccination was 68 days for MenB-4C versus 258 days for MenB-FHbp.
In the Medicaid database, the rate of vaccine completion within 15 months of initiation was 49% for MenB-4C and 31% for MenB-FHbp; dosing schedule adherence was 48% and 8%, respectively. Median time to vaccine completion was 88 days for MenB-4C versus 309 days for MenB-FHbp.
“The observations of improved completion and schedule adherence rates for MenB-4C, compared with MenB-FHbp, were consistent across both the commercial and Medicaid populations, and persisted after adjusting for individual factors in multivariable analyses, suggesting that the results were not skewed by population differences in demographic or other characteristics,” the investigators noted, adding that the significant difference in completion and schedule adherence between vaccines likely reflects the MenB-4C flexible dosing schedule.
The study was funded by GlaxoSmithKline, the maker of MenB-4C, and four coauthors reported being employed by the company. Five coauthors were employed by IBM Watson Health, which conducted the study.
SOURCE: Packnett E et al. Vaccine. 2019 Aug 20. doi: 10.1016/j.vaccine.2019.06.065.
FROM VACCINE
Mysterious vaping lung injuries may have flown under regulatory radar
It was the arrival of the second man in his early 20s gasping for air that alarmed Dixie Harris, MD. Young patients rarely get so sick, so fast, with a severe lung illness, and this was her second case in a matter of days.
Then she saw three more patients at her Utah telehealth clinic with similar symptoms. They did not have infections, but all had been vaping. When Dr. Harris heard several teenagers in Wisconsin had been hospitalized in similar cases, she quickly alerted her state health department.
As patients in hospitals across the country combat a mysterious illness linked to e-cigarettes, federal and state investigators are frantically trying to trace the outbreaks to specific vaping products that, until recently, were virtually unregulated.
As of Aug. 22, 2019, 193 potential vaping-related illnesses in 22 states had been reported to the Centers for Disease Control and Prevention. Wisconsin, which first put out an alert in July, has at least 16 confirmed and 15 suspected cases. Illinois has reported 34 patients, 1 of whom has died. Indiana is investigating 24 cases.
Lung doctors said they had seen warning signs for years that vaping could be hazardous as they treated patients. Medically it seemed problematic since it often involved inhaling chemicals not normally inhaled into the lungs. Despite that, assessing the safety of a new product storming the market fell between regulatory cracks, leaving doctors unsure where to register concerns before the outbreak. The Food and Drug Administration took years to regulate e-cigarettes once a court determined it had the authority to do so.
“You don’t know what you’re putting into your lungs when you vape,” said Dr. Harris, a critical care pulmonologist. “It’s purported to be safe, but how do you know if it’s safe? To me, it’s a very dangerous thing.”
Off the radar
When e-cigarettes came to market about a decade ago, they fell into a regulatory no man’s land. They are not a food, not a drug, and not a medical device, any of which would have put them immediately in the FDA’s purview. And, until a few years ago, they weren’t even lumped in with tobacco products.
As a result, billions of dollars of vaping products have been sold online, at big-box retailers, and in corner stores without going through the FDA’s rigorous review process to assess their safety. Companies like Juul, Blu, and NJoy quickly established their brands of devices and cartridges, or pods. And thousands of related products are sold, sometimes on the black market, over the Internet, or beyond.
“It makes it really tough because we don’t know what we’re looking for,” said Ruth Lynfield, MD, the state epidemiologist for Minnesota, where several patients were admitted to the ICU as a result of the illness. She added that, if it turns out that the products in question were sold by unregistered retailers and manufacturers “on the street,” outbreak sleuths will have a harder time figuring out exactly what is in them.
With e-cigarettes, people can vape – or smoke – nicotine products, selecting flavorings like mint, mango, blueberry crème brûlée, or cookies and milk. They can also inhale cannabis products. Many are hopeful that e-cigarettes might be useful smoking cessation tools, but some research has called that into question.
The mysterious pulmonary disease cases have been linked to vaping, but it’s unclear whether there is a common device or chemical. In some states, including California and Utah, all of the patients had vaped cannabis products. One or more substances could be involved, health officials have said. The products used by several victims are being tested to see what they contained.
And this has apparently been the case for years.
Multiple doctors described seeing earlier cases of severe lung problems linked to vaping that were not officially reported or included in the current CDC count.
Laura Crotty Alexander, MD, a pulmonologist and researcher with the University of California, San Diego, said she saw her first case about 2 years ago. A young man had been vaping for months with the same device but developed acute lung injury when he switched flavors. She strongly suspected a link, but did not report the illness anywhere.
“It wasn’t that I didn’t want to report it, it’s that there’s no pathway” to do so, Dr. Alexander said.
She said she’s concerned that many physicians haven’t been asking patients about e-cigarette use and that there’s no way to document a case like this in the medical coding system.
John E. Parker, MD, of West Virginia University, Morgantown, said he saw his first patient with pneumonia tied to vaping in 2015. Doctors there were intrigued enough to report on the case at the annual meeting of the American College of Chest Physicians. Dr. Parker and his team didn’t contact a federal agency, and Dr. Parker said it was unclear whom to call.
Numerous other cases have been reported in medical journals and at professional conferences in the years since. The FDA’s voluntary system for reporting tobacco-related health problems included 96 seizures and only 1 lung ailment tied to e-cigarettes between April and June 2019. The system appears to be utilized most by concerned citizens, rather than manufacturers or health care professionals.
But several lung specialists said that due to the patchwork nature of regulatory oversight over the years, the true scope of the problem is yet to be identified.
“We do know that e-cigarettes do not emit a harmless aerosol,” said Brian King, PhD, MPH, a deputy director in the Office on Smoking and Health at the CDC in a call with media on Aug. 23 about the outbreak. “It is possible that some of these cases were already occurring but we were not picking them up.”
Regulatory limits
The FDA has had limited authority to regulate e-cigarettes over the years.
In 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act, empowering the FDA to oversee the safety and sale of tobacco products. But e-cigarettes, still new, were not top of mind.
Later that year, the FDA tried to block imports of e-cigarettes, saying the combination drug-device products were unapproved and therefore illegal for sale in the United States. Two vaping companies, Smoking Everywhere and NJoy, sued, and a federal judge ruled in 2010 that the FDA should regulate e-cigarettes as tobacco products.
It took the agency 6 years to finalize what’s become known as the “deeming rule,” in which it formally began regulating e-cigarettes and e-liquids.
By then, it was May 2016, and the e-cigarette market had swelled to an estimated $4.1 billion, Wells Fargo Securities analyst Bonnie Herzog said at the time. Market researchers now project that the global industry could reach $48 billion by 2023.
Critics say the FDA took too long to act.
“I think the fact that FDA has been dillydallying [has made] figuring out what’s going on [with this outbreak] much harder,” said Stanton Glantz, PhD, a University of California, San Francisco, professor in its Center for Tobacco Control Research and Education. “No question.”
The agency began by banning e-cigarette sales to minors and requiring all new vaping products to submit applications for authorization before they could come to market. Companies and retailers with thousands of products already on the market were granted 2 years to submit applications, and the FDA would get an additional year to evaluate the applications. Meanwhile, existing products could still be sold.
But when Scott Gottlieb, MD, arrived as the new FDA commissioner in 2017, the rule hadn’t been implemented and there was no formal guidance for companies to file applications, he said. As a result, he pushed the deadline back to 2022, drawing ire from public health advocates, who called foul over his previous ties to an e-cigarette retailer called Kure.
“I thought e-cigarettes at the time – and I still believe – that they represent an opportunity for currently addicted adult smokers to transition off of combustible tobacco,” he said in an interview, adding that other parts of the deeming rule went into effect as planned. “All I did was delay the application deadline.”
Dr. Gottlieb’s thinking changed the following year, when a national survey showed a sharp rise in teen vaping, which he called an “epidemic.” He announced that the agency would rethink the extended deadline and weigh whether to take flavors that appeal to kids off the market.
A judge ruled last month that e-cigarette makers would have only 10 more months to submit applications to the FDA. They’re now due in May 2020.
Asked about the lung injuries appearing now, Dr. Gottlieb, who left the FDA in April 2019, said he suspected counterfeit pods are to blame, given the geographic clustering of cases and the fact that, overall, the FDA is inspecting registered e-cigarette makers and retailers to make sure they’re complying with existing regulations.
“I think the manufacturers are culpable if their products are being used, whether the liquids are counterfeit or real,” he said. “Ultimately, they’re responsible for keeping their products out of the hands of kids.”
Juul, the leading e-cigarette maker, agreed that children shouldn’t be able to vape its products, and said curtailing access should be done “through significant regulation” and “enforcement.”
“When people say ‘Why aren’t these being regulated?’ They actually are all being regulated,” Dr. Gottlieb said.
For example, companies are required to label their products as potentially addictive, sell only to adults and comply with manufacturing standards. The agency has conducted thousands of inspections of e-cigarette manufacturers and retailers and taken enforcement actions against companies selling e-cigarettes that look like juice boxes, and against a company that was putting the ingredients found in erectile dysfunction drugs into its vape liquid.
Health departments investigating the outbreak told Kaiser Health News that e-cigarettes’ niche as a tobacco product instead of a drug has presented challenges. Most weren’t aware that adverse events could be reported to a database that tracks problems with tobacco products. And, because e-cigarettes never went through the FDA’s “gold-standard” approval process for drugs, doctors can’t readily look up a detailed list of known side effects.
But like other arms of the FDA, the tobacco office has tools and a team to investigate a public health threat just as the teams for drugs and devices do, Dr. Gottlieb said. It may even be better equipped because of its funding.
“I don’t think FDA is operating in any way with hands tied behind its back because of the way that the statute is set up,” he said.
Teen vaping has exploded during this regulatory tussle. In 2011, 1.5% of high school students reported vaping. By 2018, it was 20.8%, according to a CDC report.
Unknown components
Still, doctors and researchers are concerned about the ingredients in e-cigarettes and how little the public knows about the risks of vaping.
In Juul’s terms and conditions, posted on its website, it says, “We encourage consumers to do their own research regarding vapor products and what is right for them.” Many ingredients in e-cigarette products, however, are protected as trade secrets.
Since at least 2013, the flavor industry has expressed concern about the use of flavoring chemicals in vaping products.
The vast majority of the chemicals have been tested only by ingesting them in small quantities because they’re encountered in foods. For most of these chemicals, there have been no tests to determine whether it is safe to inhale them, as happens daily by millions when they use e-cigarettes.
“Many of the ingredients of vaping products, including flavoring substances, have not been tested for … the exposure one would get from using a vaping device,” said John Hallagan, a senior adviser to the Flavor and Extract Manufacturers Association. The group has sent cease-and-desist letters to e-cigarette companies in previous years for using the food safety certification of the flavor industry to imply that the chemicals are also safe in e-cigarettes.
Some flavor chemicals are thought to be harmful when inhaled in high doses. Research suggests that cinnamaldehyde, the main component of many cinnamon flavors, may impair lung function when inhaled. Sven-Eric Jordt, PhD, a professor at Duke University, Durham, N.C., says he presented evidence of its dangers at an FDA meeting in 2015 — and its relative abundance in many e-cigarette vaping liquids. In response, one major e-cigarette liquid seller, Tasty Vapor, voluntarily took its cinnamon-flavored liquid off the shelves.
In 2017, when Dr. Gottlieb delayed the FDA application deadline, the product was back. A company email to its customers put it this way: “Two years ago, Tasty Vapor allowed itself to be intimidated by scaremongering tactics. … We lost a lot of sales as well as a good number of long-time customers. We no long see reason to disappoint our customers hostage for these shady tactics.”
At the time of publication, Tasty Vapor’s owner did not reply to a request for comment.
Dr. Jordt said he is frustrated by the delays in the regulatory approval process.
“As a parent, I would say that the government has not acted on this,” he said. “You’re basically left to act alone with your addicted kid. It’s kind of terrifying that this was allowed to happen. The industry needs to be held to account.”
Kaiser Health News correspondents Cara Anthony, Markian Hawryluk, and Lauren Weber, as well as reporter Victoria Knight contributed to this report. This story first published on California Healthline, a service of the California Health Care Foundation.
Kaiser Health News is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.
It was the arrival of the second man in his early 20s gasping for air that alarmed Dixie Harris, MD. Young patients rarely get so sick, so fast, with a severe lung illness, and this was her second case in a matter of days.
Then she saw three more patients at her Utah telehealth clinic with similar symptoms. They did not have infections, but all had been vaping. When Dr. Harris heard several teenagers in Wisconsin had been hospitalized in similar cases, she quickly alerted her state health department.
As patients in hospitals across the country combat a mysterious illness linked to e-cigarettes, federal and state investigators are frantically trying to trace the outbreaks to specific vaping products that, until recently, were virtually unregulated.
As of Aug. 22, 2019, 193 potential vaping-related illnesses in 22 states had been reported to the Centers for Disease Control and Prevention. Wisconsin, which first put out an alert in July, has at least 16 confirmed and 15 suspected cases. Illinois has reported 34 patients, 1 of whom has died. Indiana is investigating 24 cases.
Lung doctors said they had seen warning signs for years that vaping could be hazardous as they treated patients. Medically it seemed problematic since it often involved inhaling chemicals not normally inhaled into the lungs. Despite that, assessing the safety of a new product storming the market fell between regulatory cracks, leaving doctors unsure where to register concerns before the outbreak. The Food and Drug Administration took years to regulate e-cigarettes once a court determined it had the authority to do so.
“You don’t know what you’re putting into your lungs when you vape,” said Dr. Harris, a critical care pulmonologist. “It’s purported to be safe, but how do you know if it’s safe? To me, it’s a very dangerous thing.”
Off the radar
When e-cigarettes came to market about a decade ago, they fell into a regulatory no man’s land. They are not a food, not a drug, and not a medical device, any of which would have put them immediately in the FDA’s purview. And, until a few years ago, they weren’t even lumped in with tobacco products.
As a result, billions of dollars of vaping products have been sold online, at big-box retailers, and in corner stores without going through the FDA’s rigorous review process to assess their safety. Companies like Juul, Blu, and NJoy quickly established their brands of devices and cartridges, or pods. And thousands of related products are sold, sometimes on the black market, over the Internet, or beyond.
“It makes it really tough because we don’t know what we’re looking for,” said Ruth Lynfield, MD, the state epidemiologist for Minnesota, where several patients were admitted to the ICU as a result of the illness. She added that, if it turns out that the products in question were sold by unregistered retailers and manufacturers “on the street,” outbreak sleuths will have a harder time figuring out exactly what is in them.
With e-cigarettes, people can vape – or smoke – nicotine products, selecting flavorings like mint, mango, blueberry crème brûlée, or cookies and milk. They can also inhale cannabis products. Many are hopeful that e-cigarettes might be useful smoking cessation tools, but some research has called that into question.
The mysterious pulmonary disease cases have been linked to vaping, but it’s unclear whether there is a common device or chemical. In some states, including California and Utah, all of the patients had vaped cannabis products. One or more substances could be involved, health officials have said. The products used by several victims are being tested to see what they contained.
And this has apparently been the case for years.
Multiple doctors described seeing earlier cases of severe lung problems linked to vaping that were not officially reported or included in the current CDC count.
Laura Crotty Alexander, MD, a pulmonologist and researcher with the University of California, San Diego, said she saw her first case about 2 years ago. A young man had been vaping for months with the same device but developed acute lung injury when he switched flavors. She strongly suspected a link, but did not report the illness anywhere.
“It wasn’t that I didn’t want to report it, it’s that there’s no pathway” to do so, Dr. Alexander said.
She said she’s concerned that many physicians haven’t been asking patients about e-cigarette use and that there’s no way to document a case like this in the medical coding system.
John E. Parker, MD, of West Virginia University, Morgantown, said he saw his first patient with pneumonia tied to vaping in 2015. Doctors there were intrigued enough to report on the case at the annual meeting of the American College of Chest Physicians. Dr. Parker and his team didn’t contact a federal agency, and Dr. Parker said it was unclear whom to call.
Numerous other cases have been reported in medical journals and at professional conferences in the years since. The FDA’s voluntary system for reporting tobacco-related health problems included 96 seizures and only 1 lung ailment tied to e-cigarettes between April and June 2019. The system appears to be utilized most by concerned citizens, rather than manufacturers or health care professionals.
But several lung specialists said that due to the patchwork nature of regulatory oversight over the years, the true scope of the problem is yet to be identified.
“We do know that e-cigarettes do not emit a harmless aerosol,” said Brian King, PhD, MPH, a deputy director in the Office on Smoking and Health at the CDC in a call with media on Aug. 23 about the outbreak. “It is possible that some of these cases were already occurring but we were not picking them up.”
Regulatory limits
The FDA has had limited authority to regulate e-cigarettes over the years.
In 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act, empowering the FDA to oversee the safety and sale of tobacco products. But e-cigarettes, still new, were not top of mind.
Later that year, the FDA tried to block imports of e-cigarettes, saying the combination drug-device products were unapproved and therefore illegal for sale in the United States. Two vaping companies, Smoking Everywhere and NJoy, sued, and a federal judge ruled in 2010 that the FDA should regulate e-cigarettes as tobacco products.
It took the agency 6 years to finalize what’s become known as the “deeming rule,” in which it formally began regulating e-cigarettes and e-liquids.
By then, it was May 2016, and the e-cigarette market had swelled to an estimated $4.1 billion, Wells Fargo Securities analyst Bonnie Herzog said at the time. Market researchers now project that the global industry could reach $48 billion by 2023.
Critics say the FDA took too long to act.
“I think the fact that FDA has been dillydallying [has made] figuring out what’s going on [with this outbreak] much harder,” said Stanton Glantz, PhD, a University of California, San Francisco, professor in its Center for Tobacco Control Research and Education. “No question.”
The agency began by banning e-cigarette sales to minors and requiring all new vaping products to submit applications for authorization before they could come to market. Companies and retailers with thousands of products already on the market were granted 2 years to submit applications, and the FDA would get an additional year to evaluate the applications. Meanwhile, existing products could still be sold.
But when Scott Gottlieb, MD, arrived as the new FDA commissioner in 2017, the rule hadn’t been implemented and there was no formal guidance for companies to file applications, he said. As a result, he pushed the deadline back to 2022, drawing ire from public health advocates, who called foul over his previous ties to an e-cigarette retailer called Kure.
“I thought e-cigarettes at the time – and I still believe – that they represent an opportunity for currently addicted adult smokers to transition off of combustible tobacco,” he said in an interview, adding that other parts of the deeming rule went into effect as planned. “All I did was delay the application deadline.”
Dr. Gottlieb’s thinking changed the following year, when a national survey showed a sharp rise in teen vaping, which he called an “epidemic.” He announced that the agency would rethink the extended deadline and weigh whether to take flavors that appeal to kids off the market.
A judge ruled last month that e-cigarette makers would have only 10 more months to submit applications to the FDA. They’re now due in May 2020.
Asked about the lung injuries appearing now, Dr. Gottlieb, who left the FDA in April 2019, said he suspected counterfeit pods are to blame, given the geographic clustering of cases and the fact that, overall, the FDA is inspecting registered e-cigarette makers and retailers to make sure they’re complying with existing regulations.
“I think the manufacturers are culpable if their products are being used, whether the liquids are counterfeit or real,” he said. “Ultimately, they’re responsible for keeping their products out of the hands of kids.”
Juul, the leading e-cigarette maker, agreed that children shouldn’t be able to vape its products, and said curtailing access should be done “through significant regulation” and “enforcement.”
“When people say ‘Why aren’t these being regulated?’ They actually are all being regulated,” Dr. Gottlieb said.
For example, companies are required to label their products as potentially addictive, sell only to adults and comply with manufacturing standards. The agency has conducted thousands of inspections of e-cigarette manufacturers and retailers and taken enforcement actions against companies selling e-cigarettes that look like juice boxes, and against a company that was putting the ingredients found in erectile dysfunction drugs into its vape liquid.
Health departments investigating the outbreak told Kaiser Health News that e-cigarettes’ niche as a tobacco product instead of a drug has presented challenges. Most weren’t aware that adverse events could be reported to a database that tracks problems with tobacco products. And, because e-cigarettes never went through the FDA’s “gold-standard” approval process for drugs, doctors can’t readily look up a detailed list of known side effects.
But like other arms of the FDA, the tobacco office has tools and a team to investigate a public health threat just as the teams for drugs and devices do, Dr. Gottlieb said. It may even be better equipped because of its funding.
“I don’t think FDA is operating in any way with hands tied behind its back because of the way that the statute is set up,” he said.
Teen vaping has exploded during this regulatory tussle. In 2011, 1.5% of high school students reported vaping. By 2018, it was 20.8%, according to a CDC report.
Unknown components
Still, doctors and researchers are concerned about the ingredients in e-cigarettes and how little the public knows about the risks of vaping.
In Juul’s terms and conditions, posted on its website, it says, “We encourage consumers to do their own research regarding vapor products and what is right for them.” Many ingredients in e-cigarette products, however, are protected as trade secrets.
Since at least 2013, the flavor industry has expressed concern about the use of flavoring chemicals in vaping products.
The vast majority of the chemicals have been tested only by ingesting them in small quantities because they’re encountered in foods. For most of these chemicals, there have been no tests to determine whether it is safe to inhale them, as happens daily by millions when they use e-cigarettes.
“Many of the ingredients of vaping products, including flavoring substances, have not been tested for … the exposure one would get from using a vaping device,” said John Hallagan, a senior adviser to the Flavor and Extract Manufacturers Association. The group has sent cease-and-desist letters to e-cigarette companies in previous years for using the food safety certification of the flavor industry to imply that the chemicals are also safe in e-cigarettes.
Some flavor chemicals are thought to be harmful when inhaled in high doses. Research suggests that cinnamaldehyde, the main component of many cinnamon flavors, may impair lung function when inhaled. Sven-Eric Jordt, PhD, a professor at Duke University, Durham, N.C., says he presented evidence of its dangers at an FDA meeting in 2015 — and its relative abundance in many e-cigarette vaping liquids. In response, one major e-cigarette liquid seller, Tasty Vapor, voluntarily took its cinnamon-flavored liquid off the shelves.
In 2017, when Dr. Gottlieb delayed the FDA application deadline, the product was back. A company email to its customers put it this way: “Two years ago, Tasty Vapor allowed itself to be intimidated by scaremongering tactics. … We lost a lot of sales as well as a good number of long-time customers. We no long see reason to disappoint our customers hostage for these shady tactics.”
At the time of publication, Tasty Vapor’s owner did not reply to a request for comment.
Dr. Jordt said he is frustrated by the delays in the regulatory approval process.
“As a parent, I would say that the government has not acted on this,” he said. “You’re basically left to act alone with your addicted kid. It’s kind of terrifying that this was allowed to happen. The industry needs to be held to account.”
Kaiser Health News correspondents Cara Anthony, Markian Hawryluk, and Lauren Weber, as well as reporter Victoria Knight contributed to this report. This story first published on California Healthline, a service of the California Health Care Foundation.
Kaiser Health News is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.
It was the arrival of the second man in his early 20s gasping for air that alarmed Dixie Harris, MD. Young patients rarely get so sick, so fast, with a severe lung illness, and this was her second case in a matter of days.
Then she saw three more patients at her Utah telehealth clinic with similar symptoms. They did not have infections, but all had been vaping. When Dr. Harris heard several teenagers in Wisconsin had been hospitalized in similar cases, she quickly alerted her state health department.
As patients in hospitals across the country combat a mysterious illness linked to e-cigarettes, federal and state investigators are frantically trying to trace the outbreaks to specific vaping products that, until recently, were virtually unregulated.
As of Aug. 22, 2019, 193 potential vaping-related illnesses in 22 states had been reported to the Centers for Disease Control and Prevention. Wisconsin, which first put out an alert in July, has at least 16 confirmed and 15 suspected cases. Illinois has reported 34 patients, 1 of whom has died. Indiana is investigating 24 cases.
Lung doctors said they had seen warning signs for years that vaping could be hazardous as they treated patients. Medically it seemed problematic since it often involved inhaling chemicals not normally inhaled into the lungs. Despite that, assessing the safety of a new product storming the market fell between regulatory cracks, leaving doctors unsure where to register concerns before the outbreak. The Food and Drug Administration took years to regulate e-cigarettes once a court determined it had the authority to do so.
“You don’t know what you’re putting into your lungs when you vape,” said Dr. Harris, a critical care pulmonologist. “It’s purported to be safe, but how do you know if it’s safe? To me, it’s a very dangerous thing.”
Off the radar
When e-cigarettes came to market about a decade ago, they fell into a regulatory no man’s land. They are not a food, not a drug, and not a medical device, any of which would have put them immediately in the FDA’s purview. And, until a few years ago, they weren’t even lumped in with tobacco products.
As a result, billions of dollars of vaping products have been sold online, at big-box retailers, and in corner stores without going through the FDA’s rigorous review process to assess their safety. Companies like Juul, Blu, and NJoy quickly established their brands of devices and cartridges, or pods. And thousands of related products are sold, sometimes on the black market, over the Internet, or beyond.
“It makes it really tough because we don’t know what we’re looking for,” said Ruth Lynfield, MD, the state epidemiologist for Minnesota, where several patients were admitted to the ICU as a result of the illness. She added that, if it turns out that the products in question were sold by unregistered retailers and manufacturers “on the street,” outbreak sleuths will have a harder time figuring out exactly what is in them.
With e-cigarettes, people can vape – or smoke – nicotine products, selecting flavorings like mint, mango, blueberry crème brûlée, or cookies and milk. They can also inhale cannabis products. Many are hopeful that e-cigarettes might be useful smoking cessation tools, but some research has called that into question.
The mysterious pulmonary disease cases have been linked to vaping, but it’s unclear whether there is a common device or chemical. In some states, including California and Utah, all of the patients had vaped cannabis products. One or more substances could be involved, health officials have said. The products used by several victims are being tested to see what they contained.
And this has apparently been the case for years.
Multiple doctors described seeing earlier cases of severe lung problems linked to vaping that were not officially reported or included in the current CDC count.
Laura Crotty Alexander, MD, a pulmonologist and researcher with the University of California, San Diego, said she saw her first case about 2 years ago. A young man had been vaping for months with the same device but developed acute lung injury when he switched flavors. She strongly suspected a link, but did not report the illness anywhere.
“It wasn’t that I didn’t want to report it, it’s that there’s no pathway” to do so, Dr. Alexander said.
She said she’s concerned that many physicians haven’t been asking patients about e-cigarette use and that there’s no way to document a case like this in the medical coding system.
John E. Parker, MD, of West Virginia University, Morgantown, said he saw his first patient with pneumonia tied to vaping in 2015. Doctors there were intrigued enough to report on the case at the annual meeting of the American College of Chest Physicians. Dr. Parker and his team didn’t contact a federal agency, and Dr. Parker said it was unclear whom to call.
Numerous other cases have been reported in medical journals and at professional conferences in the years since. The FDA’s voluntary system for reporting tobacco-related health problems included 96 seizures and only 1 lung ailment tied to e-cigarettes between April and June 2019. The system appears to be utilized most by concerned citizens, rather than manufacturers or health care professionals.
But several lung specialists said that due to the patchwork nature of regulatory oversight over the years, the true scope of the problem is yet to be identified.
“We do know that e-cigarettes do not emit a harmless aerosol,” said Brian King, PhD, MPH, a deputy director in the Office on Smoking and Health at the CDC in a call with media on Aug. 23 about the outbreak. “It is possible that some of these cases were already occurring but we were not picking them up.”
Regulatory limits
The FDA has had limited authority to regulate e-cigarettes over the years.
In 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act, empowering the FDA to oversee the safety and sale of tobacco products. But e-cigarettes, still new, were not top of mind.
Later that year, the FDA tried to block imports of e-cigarettes, saying the combination drug-device products were unapproved and therefore illegal for sale in the United States. Two vaping companies, Smoking Everywhere and NJoy, sued, and a federal judge ruled in 2010 that the FDA should regulate e-cigarettes as tobacco products.
It took the agency 6 years to finalize what’s become known as the “deeming rule,” in which it formally began regulating e-cigarettes and e-liquids.
By then, it was May 2016, and the e-cigarette market had swelled to an estimated $4.1 billion, Wells Fargo Securities analyst Bonnie Herzog said at the time. Market researchers now project that the global industry could reach $48 billion by 2023.
Critics say the FDA took too long to act.
“I think the fact that FDA has been dillydallying [has made] figuring out what’s going on [with this outbreak] much harder,” said Stanton Glantz, PhD, a University of California, San Francisco, professor in its Center for Tobacco Control Research and Education. “No question.”
The agency began by banning e-cigarette sales to minors and requiring all new vaping products to submit applications for authorization before they could come to market. Companies and retailers with thousands of products already on the market were granted 2 years to submit applications, and the FDA would get an additional year to evaluate the applications. Meanwhile, existing products could still be sold.
But when Scott Gottlieb, MD, arrived as the new FDA commissioner in 2017, the rule hadn’t been implemented and there was no formal guidance for companies to file applications, he said. As a result, he pushed the deadline back to 2022, drawing ire from public health advocates, who called foul over his previous ties to an e-cigarette retailer called Kure.
“I thought e-cigarettes at the time – and I still believe – that they represent an opportunity for currently addicted adult smokers to transition off of combustible tobacco,” he said in an interview, adding that other parts of the deeming rule went into effect as planned. “All I did was delay the application deadline.”
Dr. Gottlieb’s thinking changed the following year, when a national survey showed a sharp rise in teen vaping, which he called an “epidemic.” He announced that the agency would rethink the extended deadline and weigh whether to take flavors that appeal to kids off the market.
A judge ruled last month that e-cigarette makers would have only 10 more months to submit applications to the FDA. They’re now due in May 2020.
Asked about the lung injuries appearing now, Dr. Gottlieb, who left the FDA in April 2019, said he suspected counterfeit pods are to blame, given the geographic clustering of cases and the fact that, overall, the FDA is inspecting registered e-cigarette makers and retailers to make sure they’re complying with existing regulations.
“I think the manufacturers are culpable if their products are being used, whether the liquids are counterfeit or real,” he said. “Ultimately, they’re responsible for keeping their products out of the hands of kids.”
Juul, the leading e-cigarette maker, agreed that children shouldn’t be able to vape its products, and said curtailing access should be done “through significant regulation” and “enforcement.”
“When people say ‘Why aren’t these being regulated?’ They actually are all being regulated,” Dr. Gottlieb said.
For example, companies are required to label their products as potentially addictive, sell only to adults and comply with manufacturing standards. The agency has conducted thousands of inspections of e-cigarette manufacturers and retailers and taken enforcement actions against companies selling e-cigarettes that look like juice boxes, and against a company that was putting the ingredients found in erectile dysfunction drugs into its vape liquid.
Health departments investigating the outbreak told Kaiser Health News that e-cigarettes’ niche as a tobacco product instead of a drug has presented challenges. Most weren’t aware that adverse events could be reported to a database that tracks problems with tobacco products. And, because e-cigarettes never went through the FDA’s “gold-standard” approval process for drugs, doctors can’t readily look up a detailed list of known side effects.
But like other arms of the FDA, the tobacco office has tools and a team to investigate a public health threat just as the teams for drugs and devices do, Dr. Gottlieb said. It may even be better equipped because of its funding.
“I don’t think FDA is operating in any way with hands tied behind its back because of the way that the statute is set up,” he said.
Teen vaping has exploded during this regulatory tussle. In 2011, 1.5% of high school students reported vaping. By 2018, it was 20.8%, according to a CDC report.
Unknown components
Still, doctors and researchers are concerned about the ingredients in e-cigarettes and how little the public knows about the risks of vaping.
In Juul’s terms and conditions, posted on its website, it says, “We encourage consumers to do their own research regarding vapor products and what is right for them.” Many ingredients in e-cigarette products, however, are protected as trade secrets.
Since at least 2013, the flavor industry has expressed concern about the use of flavoring chemicals in vaping products.
The vast majority of the chemicals have been tested only by ingesting them in small quantities because they’re encountered in foods. For most of these chemicals, there have been no tests to determine whether it is safe to inhale them, as happens daily by millions when they use e-cigarettes.
“Many of the ingredients of vaping products, including flavoring substances, have not been tested for … the exposure one would get from using a vaping device,” said John Hallagan, a senior adviser to the Flavor and Extract Manufacturers Association. The group has sent cease-and-desist letters to e-cigarette companies in previous years for using the food safety certification of the flavor industry to imply that the chemicals are also safe in e-cigarettes.
Some flavor chemicals are thought to be harmful when inhaled in high doses. Research suggests that cinnamaldehyde, the main component of many cinnamon flavors, may impair lung function when inhaled. Sven-Eric Jordt, PhD, a professor at Duke University, Durham, N.C., says he presented evidence of its dangers at an FDA meeting in 2015 — and its relative abundance in many e-cigarette vaping liquids. In response, one major e-cigarette liquid seller, Tasty Vapor, voluntarily took its cinnamon-flavored liquid off the shelves.
In 2017, when Dr. Gottlieb delayed the FDA application deadline, the product was back. A company email to its customers put it this way: “Two years ago, Tasty Vapor allowed itself to be intimidated by scaremongering tactics. … We lost a lot of sales as well as a good number of long-time customers. We no long see reason to disappoint our customers hostage for these shady tactics.”
At the time of publication, Tasty Vapor’s owner did not reply to a request for comment.
Dr. Jordt said he is frustrated by the delays in the regulatory approval process.
“As a parent, I would say that the government has not acted on this,” he said. “You’re basically left to act alone with your addicted kid. It’s kind of terrifying that this was allowed to happen. The industry needs to be held to account.”
Kaiser Health News correspondents Cara Anthony, Markian Hawryluk, and Lauren Weber, as well as reporter Victoria Knight contributed to this report. This story first published on California Healthline, a service of the California Health Care Foundation.
Kaiser Health News is a national health policy news service. It is an editorially independent program of the Henry J. Kaiser Family Foundation which is not affiliated with Kaiser Permanente.
ACOG advises bleeding disorder screening for teens with heavy menstruation
Adolescent girls with heavy menstrual bleeding should be assessed for bleeding disorders, according to a Committee Opinion issued by the American College of Obstetricians and Gynecologists.
A bleeding disorder is secondary only to anovulation as a cause of heavy menstrual bleeding in adolescents.
Bleeding disorders affect 1%-2% of the general population, but are “found in approximately 20% of adolescent girls who present for evaluation of heavy menstrual bleeding and in 33% of adolescent girls hospitalized for heavy menstrual bleeding,” wrote Oluyemisi Adeyemi-Fowode, MD, and Judith Simms-Cendan, MD, and members of the ACOG Committee on Adolescent Health Care in the opinion, published in Obstetrics & Gynecology.
The committee advised that physical examination of teens with acute heavy menstrual bleeding should include assessment of hemodynamic stability with orthostatic blood pressure and pulse measurements. A speculum exam is not usually needed in teen girls with heavy menstrual bleeding. Evaluation should include screening for anemia attributable to blood loss with serum ferritin, endocrine disorders, and bleeding disorders. In suspected cases of bleeding disorders, laboratory evaluation and medical management should be done in consultation with a hematologist.
Those who are actively bleeding or hemodynamically unstable should be hospitalized for medical management, they said.
Ultrasonography is not necessary for an initial work-up of teens with heavy menstrual bleeding, but could be useful in patients who fail to respond to medical management.
Adolescent girls without contraindications to estrogen can be treated with hormone therapy in various forms including intravenous conjugated estrogen every 4-6 hours or oral 30-50 mg ethinyl estradiol every 6-8 hours until cessation of bleeding. Antifibrinolytics also can be used to stop bleeding.
Maintenance therapy after correction of acute heavy bleeding can include a combination of treatments such as hormonal contraceptives, oral and injectable progestins, and levonorgestrel-releasing intrauterine devices, the committee wrote. They also recommended oral iron replacement therapy for all women of reproductive age with anemia caused by menstrual bleeding.
If a patient fails to respond to medical therapy, nonmedical options or surgery may be considered, according to the committee. In addition, all teen girls with bleeding disorders should be advised about safe medication use, including the use of aspirin or NSAIDs only on the recommendation of a hematologist.
Patients and their families need education on menstrual issues including possible options for surgery in the future if heavy menstruation does not resolve. If a patient has a known bleeding disorder and is considering surgery, preoperative evaluation should include a consultation with a hematologist and an anesthesiologist, the committee noted.
Melissa Kottke, MD, MPH, said in an interview, “Every ob.gyn. will see a young patient with ‘heavy menstrual bleeding.’ And it becomes part of the art and challenge to work with the patient and family to collectively explore if this is, indeed, ‘heavy’ and of concern … or is it is a ‘normal’ menstrual period and simply reflects a newer life experience that would benefit from some education? And the stakes are high. Young people who have heavy menstrual cycles are much more likely to have an underlying bleeding disorder than the general population (20% vs. 1%-2%), and 75%-80% of adolescents with bleeding disorders report heavy menses as the most common clinical manifestation of their disorder.
“Fortunately, Committee Opinion 785, ‘Screening and Management of Bleeding Disorders in Adolescents with Heavy Menstrual Bleeding’ from the ACOG Committee on Adolescent Health Care is detailed and pragmatic. It outlines how to translate everyday conversations with young people about their menses into a quantifiable estimate of bleeding, including a very teen-friendly Pictorial Blood Loss Assessment Chart. It also gives ob.gyns. ever-important guidance about what to do next for evaluation and diagnosis. This committee opinion nicely outlines how to help manage heavy bleeding in an adolescent with a detailed algorithm. And very importantly, it gives clear management guidance and encourages ob.gyns. to avoid frequently unnecessary (speculum exams and ultrasounds) and excessive (early transfusion or surgical interventions) approaches to management for the young patient. I think it will be a great resource for any provider who is taking care of heavy menstrual bleeding for a young person,” said Dr. Kottke, who is director of the Jane Fonda Center for Adolescent Reproductive Health and associate professor of gynecology and obstetrics, both at Emory University, Atlanta. Dr. Kottke is not a member of the ACOG Committee on Adolescent Health and was asked to comment on the opinion.*
The complete opinion, ACOG Committee Opinion number 785, includes recommended laboratory tests, an eight-question screening tool, and a management algorithm.
The committee members had no financial conflicts to disclose. Dr. Kottke said she had no relevant financial disclosures.
SOURCE: Adeyemi-Fowode O and Simms-Cendan J. Obstet Gynecol. 2019 Sep. 134:e71-83.
*This article was updated on 9/9/2019.
Adolescent girls with heavy menstrual bleeding should be assessed for bleeding disorders, according to a Committee Opinion issued by the American College of Obstetricians and Gynecologists.
A bleeding disorder is secondary only to anovulation as a cause of heavy menstrual bleeding in adolescents.
Bleeding disorders affect 1%-2% of the general population, but are “found in approximately 20% of adolescent girls who present for evaluation of heavy menstrual bleeding and in 33% of adolescent girls hospitalized for heavy menstrual bleeding,” wrote Oluyemisi Adeyemi-Fowode, MD, and Judith Simms-Cendan, MD, and members of the ACOG Committee on Adolescent Health Care in the opinion, published in Obstetrics & Gynecology.
The committee advised that physical examination of teens with acute heavy menstrual bleeding should include assessment of hemodynamic stability with orthostatic blood pressure and pulse measurements. A speculum exam is not usually needed in teen girls with heavy menstrual bleeding. Evaluation should include screening for anemia attributable to blood loss with serum ferritin, endocrine disorders, and bleeding disorders. In suspected cases of bleeding disorders, laboratory evaluation and medical management should be done in consultation with a hematologist.
Those who are actively bleeding or hemodynamically unstable should be hospitalized for medical management, they said.
Ultrasonography is not necessary for an initial work-up of teens with heavy menstrual bleeding, but could be useful in patients who fail to respond to medical management.
Adolescent girls without contraindications to estrogen can be treated with hormone therapy in various forms including intravenous conjugated estrogen every 4-6 hours or oral 30-50 mg ethinyl estradiol every 6-8 hours until cessation of bleeding. Antifibrinolytics also can be used to stop bleeding.
Maintenance therapy after correction of acute heavy bleeding can include a combination of treatments such as hormonal contraceptives, oral and injectable progestins, and levonorgestrel-releasing intrauterine devices, the committee wrote. They also recommended oral iron replacement therapy for all women of reproductive age with anemia caused by menstrual bleeding.
If a patient fails to respond to medical therapy, nonmedical options or surgery may be considered, according to the committee. In addition, all teen girls with bleeding disorders should be advised about safe medication use, including the use of aspirin or NSAIDs only on the recommendation of a hematologist.
Patients and their families need education on menstrual issues including possible options for surgery in the future if heavy menstruation does not resolve. If a patient has a known bleeding disorder and is considering surgery, preoperative evaluation should include a consultation with a hematologist and an anesthesiologist, the committee noted.
Melissa Kottke, MD, MPH, said in an interview, “Every ob.gyn. will see a young patient with ‘heavy menstrual bleeding.’ And it becomes part of the art and challenge to work with the patient and family to collectively explore if this is, indeed, ‘heavy’ and of concern … or is it is a ‘normal’ menstrual period and simply reflects a newer life experience that would benefit from some education? And the stakes are high. Young people who have heavy menstrual cycles are much more likely to have an underlying bleeding disorder than the general population (20% vs. 1%-2%), and 75%-80% of adolescents with bleeding disorders report heavy menses as the most common clinical manifestation of their disorder.
“Fortunately, Committee Opinion 785, ‘Screening and Management of Bleeding Disorders in Adolescents with Heavy Menstrual Bleeding’ from the ACOG Committee on Adolescent Health Care is detailed and pragmatic. It outlines how to translate everyday conversations with young people about their menses into a quantifiable estimate of bleeding, including a very teen-friendly Pictorial Blood Loss Assessment Chart. It also gives ob.gyns. ever-important guidance about what to do next for evaluation and diagnosis. This committee opinion nicely outlines how to help manage heavy bleeding in an adolescent with a detailed algorithm. And very importantly, it gives clear management guidance and encourages ob.gyns. to avoid frequently unnecessary (speculum exams and ultrasounds) and excessive (early transfusion or surgical interventions) approaches to management for the young patient. I think it will be a great resource for any provider who is taking care of heavy menstrual bleeding for a young person,” said Dr. Kottke, who is director of the Jane Fonda Center for Adolescent Reproductive Health and associate professor of gynecology and obstetrics, both at Emory University, Atlanta. Dr. Kottke is not a member of the ACOG Committee on Adolescent Health and was asked to comment on the opinion.*
The complete opinion, ACOG Committee Opinion number 785, includes recommended laboratory tests, an eight-question screening tool, and a management algorithm.
The committee members had no financial conflicts to disclose. Dr. Kottke said she had no relevant financial disclosures.
SOURCE: Adeyemi-Fowode O and Simms-Cendan J. Obstet Gynecol. 2019 Sep. 134:e71-83.
*This article was updated on 9/9/2019.
Adolescent girls with heavy menstrual bleeding should be assessed for bleeding disorders, according to a Committee Opinion issued by the American College of Obstetricians and Gynecologists.
A bleeding disorder is secondary only to anovulation as a cause of heavy menstrual bleeding in adolescents.
Bleeding disorders affect 1%-2% of the general population, but are “found in approximately 20% of adolescent girls who present for evaluation of heavy menstrual bleeding and in 33% of adolescent girls hospitalized for heavy menstrual bleeding,” wrote Oluyemisi Adeyemi-Fowode, MD, and Judith Simms-Cendan, MD, and members of the ACOG Committee on Adolescent Health Care in the opinion, published in Obstetrics & Gynecology.
The committee advised that physical examination of teens with acute heavy menstrual bleeding should include assessment of hemodynamic stability with orthostatic blood pressure and pulse measurements. A speculum exam is not usually needed in teen girls with heavy menstrual bleeding. Evaluation should include screening for anemia attributable to blood loss with serum ferritin, endocrine disorders, and bleeding disorders. In suspected cases of bleeding disorders, laboratory evaluation and medical management should be done in consultation with a hematologist.
Those who are actively bleeding or hemodynamically unstable should be hospitalized for medical management, they said.
Ultrasonography is not necessary for an initial work-up of teens with heavy menstrual bleeding, but could be useful in patients who fail to respond to medical management.
Adolescent girls without contraindications to estrogen can be treated with hormone therapy in various forms including intravenous conjugated estrogen every 4-6 hours or oral 30-50 mg ethinyl estradiol every 6-8 hours until cessation of bleeding. Antifibrinolytics also can be used to stop bleeding.
Maintenance therapy after correction of acute heavy bleeding can include a combination of treatments such as hormonal contraceptives, oral and injectable progestins, and levonorgestrel-releasing intrauterine devices, the committee wrote. They also recommended oral iron replacement therapy for all women of reproductive age with anemia caused by menstrual bleeding.
If a patient fails to respond to medical therapy, nonmedical options or surgery may be considered, according to the committee. In addition, all teen girls with bleeding disorders should be advised about safe medication use, including the use of aspirin or NSAIDs only on the recommendation of a hematologist.
Patients and their families need education on menstrual issues including possible options for surgery in the future if heavy menstruation does not resolve. If a patient has a known bleeding disorder and is considering surgery, preoperative evaluation should include a consultation with a hematologist and an anesthesiologist, the committee noted.
Melissa Kottke, MD, MPH, said in an interview, “Every ob.gyn. will see a young patient with ‘heavy menstrual bleeding.’ And it becomes part of the art and challenge to work with the patient and family to collectively explore if this is, indeed, ‘heavy’ and of concern … or is it is a ‘normal’ menstrual period and simply reflects a newer life experience that would benefit from some education? And the stakes are high. Young people who have heavy menstrual cycles are much more likely to have an underlying bleeding disorder than the general population (20% vs. 1%-2%), and 75%-80% of adolescents with bleeding disorders report heavy menses as the most common clinical manifestation of their disorder.
“Fortunately, Committee Opinion 785, ‘Screening and Management of Bleeding Disorders in Adolescents with Heavy Menstrual Bleeding’ from the ACOG Committee on Adolescent Health Care is detailed and pragmatic. It outlines how to translate everyday conversations with young people about their menses into a quantifiable estimate of bleeding, including a very teen-friendly Pictorial Blood Loss Assessment Chart. It also gives ob.gyns. ever-important guidance about what to do next for evaluation and diagnosis. This committee opinion nicely outlines how to help manage heavy bleeding in an adolescent with a detailed algorithm. And very importantly, it gives clear management guidance and encourages ob.gyns. to avoid frequently unnecessary (speculum exams and ultrasounds) and excessive (early transfusion or surgical interventions) approaches to management for the young patient. I think it will be a great resource for any provider who is taking care of heavy menstrual bleeding for a young person,” said Dr. Kottke, who is director of the Jane Fonda Center for Adolescent Reproductive Health and associate professor of gynecology and obstetrics, both at Emory University, Atlanta. Dr. Kottke is not a member of the ACOG Committee on Adolescent Health and was asked to comment on the opinion.*
The complete opinion, ACOG Committee Opinion number 785, includes recommended laboratory tests, an eight-question screening tool, and a management algorithm.
The committee members had no financial conflicts to disclose. Dr. Kottke said she had no relevant financial disclosures.
SOURCE: Adeyemi-Fowode O and Simms-Cendan J. Obstet Gynecol. 2019 Sep. 134:e71-83.
*This article was updated on 9/9/2019.
FROM OBSTETRICS AND GYNECOLOGY
Fifty-one percent of U.S. adolescents fully vaccinated against HPV
according to a report published in Morbidity and Mortality Weekly Report.
Researchers analyzed data from 18,700 adolescents aged 13-17 years – 48% of whom were female – in the 2018 National Immunization Survey–Teen to discover that 51% of adolescents were up to date with the human papillomavirus (HPV) vaccine, and 68% had received at least one dose of the vaccine.
There was an increase in HPV vaccination coverage from 2017 to 2018, but this was attributable to a 4.4 percentage point increase in males who were up to date, compared with a 0.6 percentage point increase in females.
“Although HPV vaccination coverage improved, increases among all adolescents were modest compared with increases in previous years and were observed only among males,” wrote Tanja Y. Walker of the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention, and coauthors.
The number of adolescents who had at least one dose of the quadrivalent meningococcal conjugate (4MenB) vaccine increased by 1.5 percentage points to 86.6%, while among individuals aged 17 years, coverage with two or more doses of 4MenB vaccine increased by 6.5 percentage points to 50.8%. Tdap coverage remained the same at 89% (MMWR 2019;68(33):718-23).
However, the study saw no significant increases in coverage with three or more hepatitis B vaccine doses, two or more MMR vaccine doses, or with one or more varicella vaccine doses in adolescents without a history of varicella disease.
Adolescents with Medicaid had higher HPV vaccination coverage than did adolescents with private health insurance. Uninsured adolescents had lower coverage overall, ranging from 4 percentage points lower for one or more varicella vaccine doses to 19 percentage points lower for two or more 4MenB vaccines, compared with adolescents with private health insurance.
Vaccination rates were lower among adolescents outside metropolitan areas, particularly when it came to being up to date with HPV vaccination, where there was a 15 percentage point difference, and with two or more doses of the quadrivalent meningococcal conjugate vaccine, where there was a 20 percentage point difference.
Provider recommendations to parents were associated with a higher rate of coverage with one or more doses of the HPV vaccine, but the prevalence of provider recommendations varied significantly from state to state. Overall, 78% of parents said they received a provider recommendation for the adolescent HPV vaccine, but that figure was as low as 60% in Mississippi and as high as 91% in Massachusetts.
Parents living in nonmetropolitan areas were less likely to report receiving a provider recommendation than were those in metropolitan principal cities.
“Equipping providers with the tools they need to give strong recommendations that emphasize the importance of HPV vaccination in preventing cancer and effectively address parental concerns is a priority, especially in states where provider recommendations were less commonly reported,” Ms. Walker and associates said.
No conflicts of interest were declared.
according to a report published in Morbidity and Mortality Weekly Report.
Researchers analyzed data from 18,700 adolescents aged 13-17 years – 48% of whom were female – in the 2018 National Immunization Survey–Teen to discover that 51% of adolescents were up to date with the human papillomavirus (HPV) vaccine, and 68% had received at least one dose of the vaccine.
There was an increase in HPV vaccination coverage from 2017 to 2018, but this was attributable to a 4.4 percentage point increase in males who were up to date, compared with a 0.6 percentage point increase in females.
“Although HPV vaccination coverage improved, increases among all adolescents were modest compared with increases in previous years and were observed only among males,” wrote Tanja Y. Walker of the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention, and coauthors.
The number of adolescents who had at least one dose of the quadrivalent meningococcal conjugate (4MenB) vaccine increased by 1.5 percentage points to 86.6%, while among individuals aged 17 years, coverage with two or more doses of 4MenB vaccine increased by 6.5 percentage points to 50.8%. Tdap coverage remained the same at 89% (MMWR 2019;68(33):718-23).
However, the study saw no significant increases in coverage with three or more hepatitis B vaccine doses, two or more MMR vaccine doses, or with one or more varicella vaccine doses in adolescents without a history of varicella disease.
Adolescents with Medicaid had higher HPV vaccination coverage than did adolescents with private health insurance. Uninsured adolescents had lower coverage overall, ranging from 4 percentage points lower for one or more varicella vaccine doses to 19 percentage points lower for two or more 4MenB vaccines, compared with adolescents with private health insurance.
Vaccination rates were lower among adolescents outside metropolitan areas, particularly when it came to being up to date with HPV vaccination, where there was a 15 percentage point difference, and with two or more doses of the quadrivalent meningococcal conjugate vaccine, where there was a 20 percentage point difference.
Provider recommendations to parents were associated with a higher rate of coverage with one or more doses of the HPV vaccine, but the prevalence of provider recommendations varied significantly from state to state. Overall, 78% of parents said they received a provider recommendation for the adolescent HPV vaccine, but that figure was as low as 60% in Mississippi and as high as 91% in Massachusetts.
Parents living in nonmetropolitan areas were less likely to report receiving a provider recommendation than were those in metropolitan principal cities.
“Equipping providers with the tools they need to give strong recommendations that emphasize the importance of HPV vaccination in preventing cancer and effectively address parental concerns is a priority, especially in states where provider recommendations were less commonly reported,” Ms. Walker and associates said.
No conflicts of interest were declared.
according to a report published in Morbidity and Mortality Weekly Report.
Researchers analyzed data from 18,700 adolescents aged 13-17 years – 48% of whom were female – in the 2018 National Immunization Survey–Teen to discover that 51% of adolescents were up to date with the human papillomavirus (HPV) vaccine, and 68% had received at least one dose of the vaccine.
There was an increase in HPV vaccination coverage from 2017 to 2018, but this was attributable to a 4.4 percentage point increase in males who were up to date, compared with a 0.6 percentage point increase in females.
“Although HPV vaccination coverage improved, increases among all adolescents were modest compared with increases in previous years and were observed only among males,” wrote Tanja Y. Walker of the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention, and coauthors.
The number of adolescents who had at least one dose of the quadrivalent meningococcal conjugate (4MenB) vaccine increased by 1.5 percentage points to 86.6%, while among individuals aged 17 years, coverage with two or more doses of 4MenB vaccine increased by 6.5 percentage points to 50.8%. Tdap coverage remained the same at 89% (MMWR 2019;68(33):718-23).
However, the study saw no significant increases in coverage with three or more hepatitis B vaccine doses, two or more MMR vaccine doses, or with one or more varicella vaccine doses in adolescents without a history of varicella disease.
Adolescents with Medicaid had higher HPV vaccination coverage than did adolescents with private health insurance. Uninsured adolescents had lower coverage overall, ranging from 4 percentage points lower for one or more varicella vaccine doses to 19 percentage points lower for two or more 4MenB vaccines, compared with adolescents with private health insurance.
Vaccination rates were lower among adolescents outside metropolitan areas, particularly when it came to being up to date with HPV vaccination, where there was a 15 percentage point difference, and with two or more doses of the quadrivalent meningococcal conjugate vaccine, where there was a 20 percentage point difference.
Provider recommendations to parents were associated with a higher rate of coverage with one or more doses of the HPV vaccine, but the prevalence of provider recommendations varied significantly from state to state. Overall, 78% of parents said they received a provider recommendation for the adolescent HPV vaccine, but that figure was as low as 60% in Mississippi and as high as 91% in Massachusetts.
Parents living in nonmetropolitan areas were less likely to report receiving a provider recommendation than were those in metropolitan principal cities.
“Equipping providers with the tools they need to give strong recommendations that emphasize the importance of HPV vaccination in preventing cancer and effectively address parental concerns is a priority, especially in states where provider recommendations were less commonly reported,” Ms. Walker and associates said.
No conflicts of interest were declared.
FROM MMWR
Key clinical point: Slightly more than half of adolescents in the United States are fully vaccinated with the HPV vaccine.
Major finding: Rates of full HPV vaccination are 51% among adolescents aged 13-17 years.
Study details: Analysis of data from 18,700 adolescents aged 13-17 years in the 2018 National Immunization Survey–Teen.
Disclosures: No conflicts of interest were declared.
Source: Walker T et al. MMWR 2019 Aug 23;68(33):718-23.
No teen herd immunity for 4CMenB in landmark trial
LJUBLJANA, SLOVENIA – The 4CMenB vaccine didn’t affect carriage of disease-causing genogroups of Neisseria meningitidis in adolescents in the landmark Australian cluster-randomized trial of herd immunity known as the “B Part of It” study, Helen S. Marshall, MD, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.
This was the largest-ever randomized trial of adolescents vaccinated against meningococcal disease, and the message, albeit somewhat disappointing, is clear: “MenB [Meningococcal serogroup B] vaccine programs should be designed to provide direct protection for those at highest risk of disease,” declared Dr. Marshall, professor of vaccinology and deputy director of the Robinson Research Institute at the University of Adelaide.
In other words, Youths in the age groups at highest risk of disease – infants and adolescents – need to routinely receive the vaccine.
The B Part of It study, whose sheer scope and rigor drew the attention of infectious disease clinical trialists the world over, randomized nearly 35,000 students at all high schools in the state of South Australia – whether urban, rural, or remote – to two doses of the 4CMenB vaccine known as Bexsero or to a nonvaccinated control group. This massive trial entailed training more than 250 nurses in the study procedures and involved 3,100 miles of travel to transport oropharyngeal swab samples obtained from students in outlying areas for centralized laboratory analysis using real-time polymerase chain reaction with meningococcal genotyping, culture for N. meningitidis, and whole-genome sequencing. Samples were obtained on day 1 of the study and 12 months later.
The investigators created widespread regional enthusiasm for this project through adept use of social media and other methods. As a result, 99.5% of students randomized to the intervention arm received one dose, while 97% got two doses. A gratifying unintended consequence of the study was that parents who’d never previously vaccinated their children enrolled them in B Part of It, Dr. Marshall noted.
The impetus for B Part of It was that, while the Australian national health insurance program covers a single dose of meningococcal conjugate MenACWY vaccine given at age 12 months and 14-19 years, MenB vaccine isn’t covered because of uncertainties about cost effectiveness and the vaccine’s impact on meningococcal carriage and herd immunity. B Part of It was designed to resolve those uncertainties.
South Australia has the highest rate of invasive meningococcal disease in the country, and more than 80% of cases there are caused by meningococcal serogroup B. Moreover, 75% of group B cases in South Australia involve the nasty hypervirulent New Zealand strain known as CC 41/44.
The primary outcome in B Part of It was the difference in carriage of the major disease-causing serotypes – groups A, B, C, W, X, and Y – between vaccinated and unvaccinated students at the 1-year follow-up mark. The carriage prevalence of all N. meningitidis in the vaccinated students went from 2.8% at baseline to 4.0% at 12 months, and similarly from 2.6% to 4.7% in unvaccinated controls. More importantly, the prevalence of disease-causing genotypes rose from 1.3% at baseline to 2.4% at follow-up in the vaccinated subjects, with a near-identical pattern seen in controls, where the prevalence rose from 1.4% to 2.4%. In an as-treated analysis, the rate of acquisition of carriage of disease-causing genotypes was identical at 2.0% in both study arms.
The 4CMenB vaccine proved reassuringly safe and effective in preventing meningococcal disease in vaccinated teens. With more than 58,000 doses of the vaccine given in the study, no new safety concerns or signals emerged. And the observed number of cases of invasive meningococcal disease in South Australian adolescent vaccine recipients to date has been significantly lower than expected.
Secondary and exploratory outcomes
Independent risk factors associated with N. meningitidis carriage in the study participants at the 1-year mark included smoking cigarettes or hookah, intimate kissing within the last week, and being in grades 11-12, as opposed to grade 10.
The vaccine had no significant impact on the carriage rate of the hypervirulent New Zealand serogroup B strain. Nor was there a vaccine impact on carriage density, as Mark McMillan, MD, reported elsewhere at ESPID 2019. But while the 4CMenB vaccine had minimal impact upon N. meningitidis carriage density, it was associated with a significant 41% increase in the likelihood of cleared carriage of disease-causing strains at 12 months, added Dr. McMillan, Dr. Marshall’s coinvestigator at University of Adelaide.
What’s next
The ongoing B Part of It School Leaver study is assessing carriage prevalence in vaccinated versus unvaccinated high schoolers in their first year after graduating.
In addition, the B Part of It investigators plan to prospectively study the impact of the 4CMen B vaccine on N. gonorrhoeae disease in an effort to confirm the intriguing findings of an earlier large, retrospective New Zealand case-control study. The Kiwis found that recipients of an outer membrane vesicle MenB vaccine had an adjusted 31% reduction in the risk of gonorrhea. This was the first-ever report of any vaccine effectiveness against this major global public health problem, in which antibiotic resistance is a growing concern (Lancet. 2017 Sep 30;390[10102]:1603-10). Dr. Marshall reported receiving research funding from GlaxoSmithKline, which markets Bexsero and was the major financial supporter of the B Part of It study.
But wait a minute...
Following Dr. Marshall’s report on the B Part of It study, outgoing ESPID president Adam Finn, MD, PhD, presented longitudinal data that he believes raise the possibility that protein-antigen vaccines such as Bexsero, which promote naturally acquired mucosal immunity, may impact on transmission population wide without reliably preventing acquisition. This would stand in stark contrast to conjugate meningococcus vaccines, which have a well-established massive impact on carriage and acquisition of N. meningitidis.
It may be that in studying throat carriage rates once in individuals immunized 12 months earlier, as in the B Part of It study, investigators are not asking the right question, proposed Dr. Finn, professor of pediatrics at the University of Bristol (England).
His research team has been obtaining throat swabs at monthly intervals in a population of 917 high schoolers aged 16-17 years. In 416 of the students, they also have collected saliva samples weekly both before and after immunization with 4CMenB vaccine, analyzing the samples for N. meningitidis by polymerase chain reaction. This is a novel method of studying meningococcal carriage they have found to be both reliable and far more acceptable to patients than oropharyngeal swabbing, which adolescents balk at if asked to do with any frequency (PLoS One. 2019 Feb 11;14[2]:e0209905).
Dr. Finn said that their findings, which need confirmation, suggest that N. meningitidis carriage is usually brief and dynamic. They also have found that carriage density varies markedly from month to month.
“We see much higher-density carriage in the adolescent population in the early months of the year in conjunction, we think, with viral infection with influenza and so forth,” he said, adding that this could have clinical implications. “It feels sort of intuitive that someone walking around with 1,000 or 10,000 times as many meningococci in their throat is more likely to be more infectious to people around them with a very small number, although this hasn’t been formally proven.”
He hopes that the Be on the TEAM (Teenagers Against Meningitis) study will help provide answers. The study is randomizing 24,000 U.K. high school students to vaccination with the meningococcal B protein–antigen vaccines Bexsero or Trumenba or to no vaccine in order to learn if there are significant herd immunity effects.
Dr. Finn’s meningococcal carriage research is funded by the Meningitis Research Foundation and the National Institute for Health Research. Dr. Marshall reported receiving research funding from GlaxoSmithKline, the major sponsor of the B Part of It study.
LJUBLJANA, SLOVENIA – The 4CMenB vaccine didn’t affect carriage of disease-causing genogroups of Neisseria meningitidis in adolescents in the landmark Australian cluster-randomized trial of herd immunity known as the “B Part of It” study, Helen S. Marshall, MD, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.
This was the largest-ever randomized trial of adolescents vaccinated against meningococcal disease, and the message, albeit somewhat disappointing, is clear: “MenB [Meningococcal serogroup B] vaccine programs should be designed to provide direct protection for those at highest risk of disease,” declared Dr. Marshall, professor of vaccinology and deputy director of the Robinson Research Institute at the University of Adelaide.
In other words, Youths in the age groups at highest risk of disease – infants and adolescents – need to routinely receive the vaccine.
The B Part of It study, whose sheer scope and rigor drew the attention of infectious disease clinical trialists the world over, randomized nearly 35,000 students at all high schools in the state of South Australia – whether urban, rural, or remote – to two doses of the 4CMenB vaccine known as Bexsero or to a nonvaccinated control group. This massive trial entailed training more than 250 nurses in the study procedures and involved 3,100 miles of travel to transport oropharyngeal swab samples obtained from students in outlying areas for centralized laboratory analysis using real-time polymerase chain reaction with meningococcal genotyping, culture for N. meningitidis, and whole-genome sequencing. Samples were obtained on day 1 of the study and 12 months later.
The investigators created widespread regional enthusiasm for this project through adept use of social media and other methods. As a result, 99.5% of students randomized to the intervention arm received one dose, while 97% got two doses. A gratifying unintended consequence of the study was that parents who’d never previously vaccinated their children enrolled them in B Part of It, Dr. Marshall noted.
The impetus for B Part of It was that, while the Australian national health insurance program covers a single dose of meningococcal conjugate MenACWY vaccine given at age 12 months and 14-19 years, MenB vaccine isn’t covered because of uncertainties about cost effectiveness and the vaccine’s impact on meningococcal carriage and herd immunity. B Part of It was designed to resolve those uncertainties.
South Australia has the highest rate of invasive meningococcal disease in the country, and more than 80% of cases there are caused by meningococcal serogroup B. Moreover, 75% of group B cases in South Australia involve the nasty hypervirulent New Zealand strain known as CC 41/44.
The primary outcome in B Part of It was the difference in carriage of the major disease-causing serotypes – groups A, B, C, W, X, and Y – between vaccinated and unvaccinated students at the 1-year follow-up mark. The carriage prevalence of all N. meningitidis in the vaccinated students went from 2.8% at baseline to 4.0% at 12 months, and similarly from 2.6% to 4.7% in unvaccinated controls. More importantly, the prevalence of disease-causing genotypes rose from 1.3% at baseline to 2.4% at follow-up in the vaccinated subjects, with a near-identical pattern seen in controls, where the prevalence rose from 1.4% to 2.4%. In an as-treated analysis, the rate of acquisition of carriage of disease-causing genotypes was identical at 2.0% in both study arms.
The 4CMenB vaccine proved reassuringly safe and effective in preventing meningococcal disease in vaccinated teens. With more than 58,000 doses of the vaccine given in the study, no new safety concerns or signals emerged. And the observed number of cases of invasive meningococcal disease in South Australian adolescent vaccine recipients to date has been significantly lower than expected.
Secondary and exploratory outcomes
Independent risk factors associated with N. meningitidis carriage in the study participants at the 1-year mark included smoking cigarettes or hookah, intimate kissing within the last week, and being in grades 11-12, as opposed to grade 10.
The vaccine had no significant impact on the carriage rate of the hypervirulent New Zealand serogroup B strain. Nor was there a vaccine impact on carriage density, as Mark McMillan, MD, reported elsewhere at ESPID 2019. But while the 4CMenB vaccine had minimal impact upon N. meningitidis carriage density, it was associated with a significant 41% increase in the likelihood of cleared carriage of disease-causing strains at 12 months, added Dr. McMillan, Dr. Marshall’s coinvestigator at University of Adelaide.
What’s next
The ongoing B Part of It School Leaver study is assessing carriage prevalence in vaccinated versus unvaccinated high schoolers in their first year after graduating.
In addition, the B Part of It investigators plan to prospectively study the impact of the 4CMen B vaccine on N. gonorrhoeae disease in an effort to confirm the intriguing findings of an earlier large, retrospective New Zealand case-control study. The Kiwis found that recipients of an outer membrane vesicle MenB vaccine had an adjusted 31% reduction in the risk of gonorrhea. This was the first-ever report of any vaccine effectiveness against this major global public health problem, in which antibiotic resistance is a growing concern (Lancet. 2017 Sep 30;390[10102]:1603-10). Dr. Marshall reported receiving research funding from GlaxoSmithKline, which markets Bexsero and was the major financial supporter of the B Part of It study.
But wait a minute...
Following Dr. Marshall’s report on the B Part of It study, outgoing ESPID president Adam Finn, MD, PhD, presented longitudinal data that he believes raise the possibility that protein-antigen vaccines such as Bexsero, which promote naturally acquired mucosal immunity, may impact on transmission population wide without reliably preventing acquisition. This would stand in stark contrast to conjugate meningococcus vaccines, which have a well-established massive impact on carriage and acquisition of N. meningitidis.
It may be that in studying throat carriage rates once in individuals immunized 12 months earlier, as in the B Part of It study, investigators are not asking the right question, proposed Dr. Finn, professor of pediatrics at the University of Bristol (England).
His research team has been obtaining throat swabs at monthly intervals in a population of 917 high schoolers aged 16-17 years. In 416 of the students, they also have collected saliva samples weekly both before and after immunization with 4CMenB vaccine, analyzing the samples for N. meningitidis by polymerase chain reaction. This is a novel method of studying meningococcal carriage they have found to be both reliable and far more acceptable to patients than oropharyngeal swabbing, which adolescents balk at if asked to do with any frequency (PLoS One. 2019 Feb 11;14[2]:e0209905).
Dr. Finn said that their findings, which need confirmation, suggest that N. meningitidis carriage is usually brief and dynamic. They also have found that carriage density varies markedly from month to month.
“We see much higher-density carriage in the adolescent population in the early months of the year in conjunction, we think, with viral infection with influenza and so forth,” he said, adding that this could have clinical implications. “It feels sort of intuitive that someone walking around with 1,000 or 10,000 times as many meningococci in their throat is more likely to be more infectious to people around them with a very small number, although this hasn’t been formally proven.”
He hopes that the Be on the TEAM (Teenagers Against Meningitis) study will help provide answers. The study is randomizing 24,000 U.K. high school students to vaccination with the meningococcal B protein–antigen vaccines Bexsero or Trumenba or to no vaccine in order to learn if there are significant herd immunity effects.
Dr. Finn’s meningococcal carriage research is funded by the Meningitis Research Foundation and the National Institute for Health Research. Dr. Marshall reported receiving research funding from GlaxoSmithKline, the major sponsor of the B Part of It study.
LJUBLJANA, SLOVENIA – The 4CMenB vaccine didn’t affect carriage of disease-causing genogroups of Neisseria meningitidis in adolescents in the landmark Australian cluster-randomized trial of herd immunity known as the “B Part of It” study, Helen S. Marshall, MD, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.
This was the largest-ever randomized trial of adolescents vaccinated against meningococcal disease, and the message, albeit somewhat disappointing, is clear: “MenB [Meningococcal serogroup B] vaccine programs should be designed to provide direct protection for those at highest risk of disease,” declared Dr. Marshall, professor of vaccinology and deputy director of the Robinson Research Institute at the University of Adelaide.
In other words, Youths in the age groups at highest risk of disease – infants and adolescents – need to routinely receive the vaccine.
The B Part of It study, whose sheer scope and rigor drew the attention of infectious disease clinical trialists the world over, randomized nearly 35,000 students at all high schools in the state of South Australia – whether urban, rural, or remote – to two doses of the 4CMenB vaccine known as Bexsero or to a nonvaccinated control group. This massive trial entailed training more than 250 nurses in the study procedures and involved 3,100 miles of travel to transport oropharyngeal swab samples obtained from students in outlying areas for centralized laboratory analysis using real-time polymerase chain reaction with meningococcal genotyping, culture for N. meningitidis, and whole-genome sequencing. Samples were obtained on day 1 of the study and 12 months later.
The investigators created widespread regional enthusiasm for this project through adept use of social media and other methods. As a result, 99.5% of students randomized to the intervention arm received one dose, while 97% got two doses. A gratifying unintended consequence of the study was that parents who’d never previously vaccinated their children enrolled them in B Part of It, Dr. Marshall noted.
The impetus for B Part of It was that, while the Australian national health insurance program covers a single dose of meningococcal conjugate MenACWY vaccine given at age 12 months and 14-19 years, MenB vaccine isn’t covered because of uncertainties about cost effectiveness and the vaccine’s impact on meningococcal carriage and herd immunity. B Part of It was designed to resolve those uncertainties.
South Australia has the highest rate of invasive meningococcal disease in the country, and more than 80% of cases there are caused by meningococcal serogroup B. Moreover, 75% of group B cases in South Australia involve the nasty hypervirulent New Zealand strain known as CC 41/44.
The primary outcome in B Part of It was the difference in carriage of the major disease-causing serotypes – groups A, B, C, W, X, and Y – between vaccinated and unvaccinated students at the 1-year follow-up mark. The carriage prevalence of all N. meningitidis in the vaccinated students went from 2.8% at baseline to 4.0% at 12 months, and similarly from 2.6% to 4.7% in unvaccinated controls. More importantly, the prevalence of disease-causing genotypes rose from 1.3% at baseline to 2.4% at follow-up in the vaccinated subjects, with a near-identical pattern seen in controls, where the prevalence rose from 1.4% to 2.4%. In an as-treated analysis, the rate of acquisition of carriage of disease-causing genotypes was identical at 2.0% in both study arms.
The 4CMenB vaccine proved reassuringly safe and effective in preventing meningococcal disease in vaccinated teens. With more than 58,000 doses of the vaccine given in the study, no new safety concerns or signals emerged. And the observed number of cases of invasive meningococcal disease in South Australian adolescent vaccine recipients to date has been significantly lower than expected.
Secondary and exploratory outcomes
Independent risk factors associated with N. meningitidis carriage in the study participants at the 1-year mark included smoking cigarettes or hookah, intimate kissing within the last week, and being in grades 11-12, as opposed to grade 10.
The vaccine had no significant impact on the carriage rate of the hypervirulent New Zealand serogroup B strain. Nor was there a vaccine impact on carriage density, as Mark McMillan, MD, reported elsewhere at ESPID 2019. But while the 4CMenB vaccine had minimal impact upon N. meningitidis carriage density, it was associated with a significant 41% increase in the likelihood of cleared carriage of disease-causing strains at 12 months, added Dr. McMillan, Dr. Marshall’s coinvestigator at University of Adelaide.
What’s next
The ongoing B Part of It School Leaver study is assessing carriage prevalence in vaccinated versus unvaccinated high schoolers in their first year after graduating.
In addition, the B Part of It investigators plan to prospectively study the impact of the 4CMen B vaccine on N. gonorrhoeae disease in an effort to confirm the intriguing findings of an earlier large, retrospective New Zealand case-control study. The Kiwis found that recipients of an outer membrane vesicle MenB vaccine had an adjusted 31% reduction in the risk of gonorrhea. This was the first-ever report of any vaccine effectiveness against this major global public health problem, in which antibiotic resistance is a growing concern (Lancet. 2017 Sep 30;390[10102]:1603-10). Dr. Marshall reported receiving research funding from GlaxoSmithKline, which markets Bexsero and was the major financial supporter of the B Part of It study.
But wait a minute...
Following Dr. Marshall’s report on the B Part of It study, outgoing ESPID president Adam Finn, MD, PhD, presented longitudinal data that he believes raise the possibility that protein-antigen vaccines such as Bexsero, which promote naturally acquired mucosal immunity, may impact on transmission population wide without reliably preventing acquisition. This would stand in stark contrast to conjugate meningococcus vaccines, which have a well-established massive impact on carriage and acquisition of N. meningitidis.
It may be that in studying throat carriage rates once in individuals immunized 12 months earlier, as in the B Part of It study, investigators are not asking the right question, proposed Dr. Finn, professor of pediatrics at the University of Bristol (England).
His research team has been obtaining throat swabs at monthly intervals in a population of 917 high schoolers aged 16-17 years. In 416 of the students, they also have collected saliva samples weekly both before and after immunization with 4CMenB vaccine, analyzing the samples for N. meningitidis by polymerase chain reaction. This is a novel method of studying meningococcal carriage they have found to be both reliable and far more acceptable to patients than oropharyngeal swabbing, which adolescents balk at if asked to do with any frequency (PLoS One. 2019 Feb 11;14[2]:e0209905).
Dr. Finn said that their findings, which need confirmation, suggest that N. meningitidis carriage is usually brief and dynamic. They also have found that carriage density varies markedly from month to month.
“We see much higher-density carriage in the adolescent population in the early months of the year in conjunction, we think, with viral infection with influenza and so forth,” he said, adding that this could have clinical implications. “It feels sort of intuitive that someone walking around with 1,000 or 10,000 times as many meningococci in their throat is more likely to be more infectious to people around them with a very small number, although this hasn’t been formally proven.”
He hopes that the Be on the TEAM (Teenagers Against Meningitis) study will help provide answers. The study is randomizing 24,000 U.K. high school students to vaccination with the meningococcal B protein–antigen vaccines Bexsero or Trumenba or to no vaccine in order to learn if there are significant herd immunity effects.
Dr. Finn’s meningococcal carriage research is funded by the Meningitis Research Foundation and the National Institute for Health Research. Dr. Marshall reported receiving research funding from GlaxoSmithKline, the major sponsor of the B Part of It study.
REPORTING FROM ESPID 2019
FCC backs designating 988 as suicide prevention hotline
A Federal Communications Commission report recommends that 988 be designated as a nationwide suicide and mental health crisis support hotline, because a three-digit number “could be more effective” than the current 10-digit number, according to an FCC release.
The report was prepared by the FCC’s Wireline Competition Bureau and Office of Economics and Analytics at the direction of the National Suicide Hotline Improvement Act of 2018. The current service, known as the National Suicide Prevention Lifeline, uses the 10-digit number of 800-273-8255 (TALK). The report noted that the hotline has proved effective: The service answered 2.2 million calls in 2018 and various assessments have shown significant reductions in hopelessness and suicidal ideation among callers.
However, based on data and conclusions from some of those assessments, the report determined “that the Lifeline could be more effective in preventing suicides and providing crisis intervention if it were accessible via a simple, easy-to-remember, 3-digit dialing code.” The report examined the feasibility of three-digit options, including N11 options such as 211 and 511, but based on an analysis by the North American Numbering Council, it found that “technical and operational concerns related to the 988 code could be more easily and quickly addressed and resolved than any re-education efforts related to repurposing a N11 code.”
Suicide and mental health crises have been on the rise, according to numbers from the Centers for Disease Control and Prevention cited by the FCC report. Among the 50 states, 49 saw increases during 1999-2016, and more than half saw increases greater than 20%. The report describes how some groups, such as veterans and LGBTQ youth, are at especially high risk:
A Federal Communications Commission report recommends that 988 be designated as a nationwide suicide and mental health crisis support hotline, because a three-digit number “could be more effective” than the current 10-digit number, according to an FCC release.
The report was prepared by the FCC’s Wireline Competition Bureau and Office of Economics and Analytics at the direction of the National Suicide Hotline Improvement Act of 2018. The current service, known as the National Suicide Prevention Lifeline, uses the 10-digit number of 800-273-8255 (TALK). The report noted that the hotline has proved effective: The service answered 2.2 million calls in 2018 and various assessments have shown significant reductions in hopelessness and suicidal ideation among callers.
However, based on data and conclusions from some of those assessments, the report determined “that the Lifeline could be more effective in preventing suicides and providing crisis intervention if it were accessible via a simple, easy-to-remember, 3-digit dialing code.” The report examined the feasibility of three-digit options, including N11 options such as 211 and 511, but based on an analysis by the North American Numbering Council, it found that “technical and operational concerns related to the 988 code could be more easily and quickly addressed and resolved than any re-education efforts related to repurposing a N11 code.”
Suicide and mental health crises have been on the rise, according to numbers from the Centers for Disease Control and Prevention cited by the FCC report. Among the 50 states, 49 saw increases during 1999-2016, and more than half saw increases greater than 20%. The report describes how some groups, such as veterans and LGBTQ youth, are at especially high risk:
A Federal Communications Commission report recommends that 988 be designated as a nationwide suicide and mental health crisis support hotline, because a three-digit number “could be more effective” than the current 10-digit number, according to an FCC release.
The report was prepared by the FCC’s Wireline Competition Bureau and Office of Economics and Analytics at the direction of the National Suicide Hotline Improvement Act of 2018. The current service, known as the National Suicide Prevention Lifeline, uses the 10-digit number of 800-273-8255 (TALK). The report noted that the hotline has proved effective: The service answered 2.2 million calls in 2018 and various assessments have shown significant reductions in hopelessness and suicidal ideation among callers.
However, based on data and conclusions from some of those assessments, the report determined “that the Lifeline could be more effective in preventing suicides and providing crisis intervention if it were accessible via a simple, easy-to-remember, 3-digit dialing code.” The report examined the feasibility of three-digit options, including N11 options such as 211 and 511, but based on an analysis by the North American Numbering Council, it found that “technical and operational concerns related to the 988 code could be more easily and quickly addressed and resolved than any re-education efforts related to repurposing a N11 code.”
Suicide and mental health crises have been on the rise, according to numbers from the Centers for Disease Control and Prevention cited by the FCC report. Among the 50 states, 49 saw increases during 1999-2016, and more than half saw increases greater than 20%. The report describes how some groups, such as veterans and LGBTQ youth, are at especially high risk:
Planned Parenthood withdraws from Title X
Planned Parenthood will no longer participate in the federal Title X family planning program in response to a Trump administration rule that prohibits physicians from counseling patients about abortion and referring patients for the procedure.
In an Aug. 19 announcement, Alexis McGill Johnson, Planned Parenthood Federation of America president and CEO, said the Title X changes, which amount to “an unethical and dangerous gag rule,” has forced the organization out of Title X after being part of the program for 50 years. Planned Parenthood health centers are the largest Title X provider, serving 40% of patients who receive care through the program.
“We believe that the Trump administration is doing this as an attack on reproductive health care and to keep providers like Planned Parenthood from serving our patients,” Ms. McGill said in a statement. “Health care shouldn’t come down to how much you earn, where you live, or who you are. Congress must act now. It’s time for the U.S. Senate to act to pass a spending bill that will reverse the harmful rule and restore access to birth control, STD testing, and other critical services to people with low incomes.”
In an Aug. 19 statement, Mia Palmieri Heck, director of external affairs for the U.S. Department of Health & Human Services said every current Title X grantee has the choice to accept their grant and comply with the changes, or reject their funding by refusing to comply.
“The new Title X regulations were final at the time the current grant awards were announced,” Ms. Heck said a statement. “Some grantees are now blaming the government for their own actions – having chosen to accept the grant while failing to comply with the regulations that accompany it – and they are abandoning their obligations to serve their patients under the program. HHS is grateful for the many grantees who continue to serve their patients under the Title X program, and we will work to ensure all patients continue to be served.”
The announcement by Planned Parenthood comes about a month after HHS gave family planning clinics more time to comply with the new rule if they are making good faith efforts to comply with the new rules. The changes to the Title X program make health clinics ineligible for funding if they offer, promote, or support abortion as a method of family planning.
So far, more than 20 states and several abortion rights organizations, including Planned Parenthood, have sued over the rules in four separate states. District judges in Oregon, Washington, and California temporarily blocked the rules from taking effect. In a June 20 decision, the 9th U.S. Circuit Court of Appeals ruled that the federal government may go forward with its plan to restrict Title X funding from clinics that provide abortion counseling or referrals. The decision overturned the lower court injunctions.
Clare Coleman, president and CEO for the National Family Planning & Reproductive Health Association, said she expects further withdrawals from the Title X program to follow Planned Parenthood’s departure.
“The administration’s Title X rule is forcing the program’s 90 grantees and nearly 4,000 service sites to make gut-wrenching choices,” Ms. Coleman said in a statement. “They can stay in the program, despite the rule’s harms and compromises to Title X’s quality of care, for the sake of continuing to offer some Title X care for low-income individuals [or] they can leave the program and forego funding in order to avoid the rule’s limits on pregnancy counseling and other essential care, contrary to HHS’s own professional standards.”
HHS has previously said that the Title X changes ensure that grants and contracts awarded under the program fully comply with the statutory program integrity requirements, “thereby fulfilling the purpose of Title X, so that more women and men can receive services that help them consider and achieve both their short-term and long-term family planning needs.” The agency recently posted guidance on its website on myths vs. facts about the changes.
Ms. Johnson meanwhile, said Planned Parenthood clinics will remain open to serve patients, and that the organization will continue to fight the Title X changes in court.
[email protected]
Planned Parenthood will no longer participate in the federal Title X family planning program in response to a Trump administration rule that prohibits physicians from counseling patients about abortion and referring patients for the procedure.
In an Aug. 19 announcement, Alexis McGill Johnson, Planned Parenthood Federation of America president and CEO, said the Title X changes, which amount to “an unethical and dangerous gag rule,” has forced the organization out of Title X after being part of the program for 50 years. Planned Parenthood health centers are the largest Title X provider, serving 40% of patients who receive care through the program.
“We believe that the Trump administration is doing this as an attack on reproductive health care and to keep providers like Planned Parenthood from serving our patients,” Ms. McGill said in a statement. “Health care shouldn’t come down to how much you earn, where you live, or who you are. Congress must act now. It’s time for the U.S. Senate to act to pass a spending bill that will reverse the harmful rule and restore access to birth control, STD testing, and other critical services to people with low incomes.”
In an Aug. 19 statement, Mia Palmieri Heck, director of external affairs for the U.S. Department of Health & Human Services said every current Title X grantee has the choice to accept their grant and comply with the changes, or reject their funding by refusing to comply.
“The new Title X regulations were final at the time the current grant awards were announced,” Ms. Heck said a statement. “Some grantees are now blaming the government for their own actions – having chosen to accept the grant while failing to comply with the regulations that accompany it – and they are abandoning their obligations to serve their patients under the program. HHS is grateful for the many grantees who continue to serve their patients under the Title X program, and we will work to ensure all patients continue to be served.”
The announcement by Planned Parenthood comes about a month after HHS gave family planning clinics more time to comply with the new rule if they are making good faith efforts to comply with the new rules. The changes to the Title X program make health clinics ineligible for funding if they offer, promote, or support abortion as a method of family planning.
So far, more than 20 states and several abortion rights organizations, including Planned Parenthood, have sued over the rules in four separate states. District judges in Oregon, Washington, and California temporarily blocked the rules from taking effect. In a June 20 decision, the 9th U.S. Circuit Court of Appeals ruled that the federal government may go forward with its plan to restrict Title X funding from clinics that provide abortion counseling or referrals. The decision overturned the lower court injunctions.
Clare Coleman, president and CEO for the National Family Planning & Reproductive Health Association, said she expects further withdrawals from the Title X program to follow Planned Parenthood’s departure.
“The administration’s Title X rule is forcing the program’s 90 grantees and nearly 4,000 service sites to make gut-wrenching choices,” Ms. Coleman said in a statement. “They can stay in the program, despite the rule’s harms and compromises to Title X’s quality of care, for the sake of continuing to offer some Title X care for low-income individuals [or] they can leave the program and forego funding in order to avoid the rule’s limits on pregnancy counseling and other essential care, contrary to HHS’s own professional standards.”
HHS has previously said that the Title X changes ensure that grants and contracts awarded under the program fully comply with the statutory program integrity requirements, “thereby fulfilling the purpose of Title X, so that more women and men can receive services that help them consider and achieve both their short-term and long-term family planning needs.” The agency recently posted guidance on its website on myths vs. facts about the changes.
Ms. Johnson meanwhile, said Planned Parenthood clinics will remain open to serve patients, and that the organization will continue to fight the Title X changes in court.
[email protected]
Planned Parenthood will no longer participate in the federal Title X family planning program in response to a Trump administration rule that prohibits physicians from counseling patients about abortion and referring patients for the procedure.
In an Aug. 19 announcement, Alexis McGill Johnson, Planned Parenthood Federation of America president and CEO, said the Title X changes, which amount to “an unethical and dangerous gag rule,” has forced the organization out of Title X after being part of the program for 50 years. Planned Parenthood health centers are the largest Title X provider, serving 40% of patients who receive care through the program.
“We believe that the Trump administration is doing this as an attack on reproductive health care and to keep providers like Planned Parenthood from serving our patients,” Ms. McGill said in a statement. “Health care shouldn’t come down to how much you earn, where you live, or who you are. Congress must act now. It’s time for the U.S. Senate to act to pass a spending bill that will reverse the harmful rule and restore access to birth control, STD testing, and other critical services to people with low incomes.”
In an Aug. 19 statement, Mia Palmieri Heck, director of external affairs for the U.S. Department of Health & Human Services said every current Title X grantee has the choice to accept their grant and comply with the changes, or reject their funding by refusing to comply.
“The new Title X regulations were final at the time the current grant awards were announced,” Ms. Heck said a statement. “Some grantees are now blaming the government for their own actions – having chosen to accept the grant while failing to comply with the regulations that accompany it – and they are abandoning their obligations to serve their patients under the program. HHS is grateful for the many grantees who continue to serve their patients under the Title X program, and we will work to ensure all patients continue to be served.”
The announcement by Planned Parenthood comes about a month after HHS gave family planning clinics more time to comply with the new rule if they are making good faith efforts to comply with the new rules. The changes to the Title X program make health clinics ineligible for funding if they offer, promote, or support abortion as a method of family planning.
So far, more than 20 states and several abortion rights organizations, including Planned Parenthood, have sued over the rules in four separate states. District judges in Oregon, Washington, and California temporarily blocked the rules from taking effect. In a June 20 decision, the 9th U.S. Circuit Court of Appeals ruled that the federal government may go forward with its plan to restrict Title X funding from clinics that provide abortion counseling or referrals. The decision overturned the lower court injunctions.
Clare Coleman, president and CEO for the National Family Planning & Reproductive Health Association, said she expects further withdrawals from the Title X program to follow Planned Parenthood’s departure.
“The administration’s Title X rule is forcing the program’s 90 grantees and nearly 4,000 service sites to make gut-wrenching choices,” Ms. Coleman said in a statement. “They can stay in the program, despite the rule’s harms and compromises to Title X’s quality of care, for the sake of continuing to offer some Title X care for low-income individuals [or] they can leave the program and forego funding in order to avoid the rule’s limits on pregnancy counseling and other essential care, contrary to HHS’s own professional standards.”
HHS has previously said that the Title X changes ensure that grants and contracts awarded under the program fully comply with the statutory program integrity requirements, “thereby fulfilling the purpose of Title X, so that more women and men can receive services that help them consider and achieve both their short-term and long-term family planning needs.” The agency recently posted guidance on its website on myths vs. facts about the changes.
Ms. Johnson meanwhile, said Planned Parenthood clinics will remain open to serve patients, and that the organization will continue to fight the Title X changes in court.
[email protected]
Are rigid HPV vaccination schedules really necessary?
LJUBLJANA, SLOVENIA – Vladimir Gilca, MD, PhD, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.
This novel observation from a post hoc analysis of two clinical trials conducted by the same research team has important potential implications for both clinical practice and public health, according to Dr. Gilca of the Quebec National Institute of Public Health and Laval University, Quebec City.
“A less rigid immunization schedule might facilitate the coadministration of HPV vaccine with other vaccines, such as meningococcal or Tdap, and reduce the number of vaccination visits. Also, our data support the decision to offer only one dose in cases of vaccine shortage, like we have presently in many countries around the world, with the possibility of giving the second dose several years later when the shortage is resolved,” he said.
He presented a comparison of anti-HPV geometric mean IgG antibody titers and their distribution in two clinical trials with serologic assays performed in the same lab using the same enzyme-linked immunosorbent assay procedures. In the first study, 173 boys and girls aged 9-10 years received two doses of a 9-valent HPV vaccine 6 months apart. In the second trial, 31 girls were vaccinated with one dose of a quadrivalent HPV vaccine at age 9-14 years and then received a dose of the 9-valent vaccine at a mean of 5.4 years and maximum of 8 years later. Blood samples were obtained before and 1 month after the second dose in both trials.
Despite the enormous differences in the time between the first and second doses in the two studies, 100% of subjects in both trials were seropositive to HPV 6, 11, 16, and 18, with similar geometric mean titers and titer distributions before dose number two. Moreover, 1 month after the second dose, the geometric mean titers jumped 40-91 times in study participants with a 6-month dosing interval, and similarly by 60-82 times in those with the far lengthier interval. Titer distributions after the second dose were equivalent in the two studies.
Dr. Gilca and coinvestigators looked at subgroups who received their second dose 3-4 years, 6, or 7-8 years after the first. The time difference didn’t affect the distribution of antibodies.
“We conclude that delayed administration of the second dose has no negative impact on the magnitude of the immune response,” he declared.
There are abundant precedents for this phenomenon of high immunogenicity of delayed doses of vaccine. Rabies, anthrax, hepatitis A and B, and tick-borne encephalitis vaccines have all been shown to elicit at least a similar magnitude of immune response after delayed administration of a second or third dose, compared with dosing at the guideline-recommended intervals, he noted.
Asked about the possible approach of giving just one dose of HPV vaccine, as was supported based upon retrospective data in a high-profile presentation earlier at ESPID 2019, Dr. Gilca replied, “The data we’ve seen so far show clinical noninferiority between one, two, and three doses. An approach that might be used by at least some countries is to give, for example, one dose of HPV vaccine in grade 4 and to then wait for confirmatory data about the efficacy of one dose, which we expect in the next 4-5 years. At least five or six clinical trials are ongoing on one dose versus two or three doses.”
He reported having no financial conflicts of interest regarding his presentation.
SOURCE: Gilca V et al. ESPID 2019, Abstract.
LJUBLJANA, SLOVENIA – Vladimir Gilca, MD, PhD, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.
This novel observation from a post hoc analysis of two clinical trials conducted by the same research team has important potential implications for both clinical practice and public health, according to Dr. Gilca of the Quebec National Institute of Public Health and Laval University, Quebec City.
“A less rigid immunization schedule might facilitate the coadministration of HPV vaccine with other vaccines, such as meningococcal or Tdap, and reduce the number of vaccination visits. Also, our data support the decision to offer only one dose in cases of vaccine shortage, like we have presently in many countries around the world, with the possibility of giving the second dose several years later when the shortage is resolved,” he said.
He presented a comparison of anti-HPV geometric mean IgG antibody titers and their distribution in two clinical trials with serologic assays performed in the same lab using the same enzyme-linked immunosorbent assay procedures. In the first study, 173 boys and girls aged 9-10 years received two doses of a 9-valent HPV vaccine 6 months apart. In the second trial, 31 girls were vaccinated with one dose of a quadrivalent HPV vaccine at age 9-14 years and then received a dose of the 9-valent vaccine at a mean of 5.4 years and maximum of 8 years later. Blood samples were obtained before and 1 month after the second dose in both trials.
Despite the enormous differences in the time between the first and second doses in the two studies, 100% of subjects in both trials were seropositive to HPV 6, 11, 16, and 18, with similar geometric mean titers and titer distributions before dose number two. Moreover, 1 month after the second dose, the geometric mean titers jumped 40-91 times in study participants with a 6-month dosing interval, and similarly by 60-82 times in those with the far lengthier interval. Titer distributions after the second dose were equivalent in the two studies.
Dr. Gilca and coinvestigators looked at subgroups who received their second dose 3-4 years, 6, or 7-8 years after the first. The time difference didn’t affect the distribution of antibodies.
“We conclude that delayed administration of the second dose has no negative impact on the magnitude of the immune response,” he declared.
There are abundant precedents for this phenomenon of high immunogenicity of delayed doses of vaccine. Rabies, anthrax, hepatitis A and B, and tick-borne encephalitis vaccines have all been shown to elicit at least a similar magnitude of immune response after delayed administration of a second or third dose, compared with dosing at the guideline-recommended intervals, he noted.
Asked about the possible approach of giving just one dose of HPV vaccine, as was supported based upon retrospective data in a high-profile presentation earlier at ESPID 2019, Dr. Gilca replied, “The data we’ve seen so far show clinical noninferiority between one, two, and three doses. An approach that might be used by at least some countries is to give, for example, one dose of HPV vaccine in grade 4 and to then wait for confirmatory data about the efficacy of one dose, which we expect in the next 4-5 years. At least five or six clinical trials are ongoing on one dose versus two or three doses.”
He reported having no financial conflicts of interest regarding his presentation.
SOURCE: Gilca V et al. ESPID 2019, Abstract.
LJUBLJANA, SLOVENIA – Vladimir Gilca, MD, PhD, reported at the annual meeting of the European Society for Paediatric Infectious Diseases.
This novel observation from a post hoc analysis of two clinical trials conducted by the same research team has important potential implications for both clinical practice and public health, according to Dr. Gilca of the Quebec National Institute of Public Health and Laval University, Quebec City.
“A less rigid immunization schedule might facilitate the coadministration of HPV vaccine with other vaccines, such as meningococcal or Tdap, and reduce the number of vaccination visits. Also, our data support the decision to offer only one dose in cases of vaccine shortage, like we have presently in many countries around the world, with the possibility of giving the second dose several years later when the shortage is resolved,” he said.
He presented a comparison of anti-HPV geometric mean IgG antibody titers and their distribution in two clinical trials with serologic assays performed in the same lab using the same enzyme-linked immunosorbent assay procedures. In the first study, 173 boys and girls aged 9-10 years received two doses of a 9-valent HPV vaccine 6 months apart. In the second trial, 31 girls were vaccinated with one dose of a quadrivalent HPV vaccine at age 9-14 years and then received a dose of the 9-valent vaccine at a mean of 5.4 years and maximum of 8 years later. Blood samples were obtained before and 1 month after the second dose in both trials.
Despite the enormous differences in the time between the first and second doses in the two studies, 100% of subjects in both trials were seropositive to HPV 6, 11, 16, and 18, with similar geometric mean titers and titer distributions before dose number two. Moreover, 1 month after the second dose, the geometric mean titers jumped 40-91 times in study participants with a 6-month dosing interval, and similarly by 60-82 times in those with the far lengthier interval. Titer distributions after the second dose were equivalent in the two studies.
Dr. Gilca and coinvestigators looked at subgroups who received their second dose 3-4 years, 6, or 7-8 years after the first. The time difference didn’t affect the distribution of antibodies.
“We conclude that delayed administration of the second dose has no negative impact on the magnitude of the immune response,” he declared.
There are abundant precedents for this phenomenon of high immunogenicity of delayed doses of vaccine. Rabies, anthrax, hepatitis A and B, and tick-borne encephalitis vaccines have all been shown to elicit at least a similar magnitude of immune response after delayed administration of a second or third dose, compared with dosing at the guideline-recommended intervals, he noted.
Asked about the possible approach of giving just one dose of HPV vaccine, as was supported based upon retrospective data in a high-profile presentation earlier at ESPID 2019, Dr. Gilca replied, “The data we’ve seen so far show clinical noninferiority between one, two, and three doses. An approach that might be used by at least some countries is to give, for example, one dose of HPV vaccine in grade 4 and to then wait for confirmatory data about the efficacy of one dose, which we expect in the next 4-5 years. At least five or six clinical trials are ongoing on one dose versus two or three doses.”
He reported having no financial conflicts of interest regarding his presentation.
SOURCE: Gilca V et al. ESPID 2019, Abstract.
REPORTING FROM ESPID 2019