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Coronavirus outbreak: Putting it into perspective
References
- Centers for Disease Control and Prevention. 2019 novel coronavirus. https://www.cdc.gov/coronavirus/2019-nCoV/hcp/index.html. Last reviewed February 8, 2020. Accessed February 9, 2020.
- World Health Organization. Novel coronavirus (2019-nCoV) situation as of 10 February 2020. http://who.maps.arcgis.com/apps/opsdashboard/index.html#/c88e37cfc43b4ed3baf977d77e4a0667. Accessed February 9, 2020.
- Centers for Disease Control and Prevention. 2019 novel coronavirus: Evaluating and reporting persons under investigation (PUI). https://www.cdc.gov/coronavirus/2019-nCoV/hcp/clinical-criteria.html Last reviewed February 3, 2020. Accessed February 9, 2020.
- Centers for Disease Control and Prevention. Weekly US influenza surveillance report. https://www.cdc.gov/flu/weekly/index.htm. Last reviewed February 7, 2020. Accessed February 12, 2020.
References
- Centers for Disease Control and Prevention. 2019 novel coronavirus. https://www.cdc.gov/coronavirus/2019-nCoV/hcp/index.html. Last reviewed February 8, 2020. Accessed February 9, 2020.
- World Health Organization. Novel coronavirus (2019-nCoV) situation as of 10 February 2020. http://who.maps.arcgis.com/apps/opsdashboard/index.html#/c88e37cfc43b4ed3baf977d77e4a0667. Accessed February 9, 2020.
- Centers for Disease Control and Prevention. 2019 novel coronavirus: Evaluating and reporting persons under investigation (PUI). https://www.cdc.gov/coronavirus/2019-nCoV/hcp/clinical-criteria.html Last reviewed February 3, 2020. Accessed February 9, 2020.
- Centers for Disease Control and Prevention. Weekly US influenza surveillance report. https://www.cdc.gov/flu/weekly/index.htm. Last reviewed February 7, 2020. Accessed February 12, 2020.
References
- Centers for Disease Control and Prevention. 2019 novel coronavirus. https://www.cdc.gov/coronavirus/2019-nCoV/hcp/index.html. Last reviewed February 8, 2020. Accessed February 9, 2020.
- World Health Organization. Novel coronavirus (2019-nCoV) situation as of 10 February 2020. http://who.maps.arcgis.com/apps/opsdashboard/index.html#/c88e37cfc43b4ed3baf977d77e4a0667. Accessed February 9, 2020.
- Centers for Disease Control and Prevention. 2019 novel coronavirus: Evaluating and reporting persons under investigation (PUI). https://www.cdc.gov/coronavirus/2019-nCoV/hcp/clinical-criteria.html Last reviewed February 3, 2020. Accessed February 9, 2020.
- Centers for Disease Control and Prevention. Weekly US influenza surveillance report. https://www.cdc.gov/flu/weekly/index.htm. Last reviewed February 7, 2020. Accessed February 12, 2020.
Flu activity increases for third straight week
For the second time during the 2019-2020 flu season, activity measures have climbed into noteworthy territory.
The proportion of outpatient visits for influenza-like illness (ILI) reached its highest December level, 7.1%, since 2003 and then dropped for 2 weeks. Three weeks of increases since then, however, have the outpatient-visit rate at 6.7% for the week ending Feb. 1, 2020, the Centers for Disease Control and Prevention reported. The baseline rate for the United States is 2.4%.
That rate of 6.7% is already above the highest rates recorded in eight of the last nine flu seasons, and another increase could mean a second, separate trip above 7.0% in the 2019-2020 season – something that has not occurred since national tracking began in 1997, CDC data show.
Those same data also show that,
Another important measure on the rise, the proportion of respiratory specimens testing positive for influenza, reached a new high for the season, 29.8%, during the week of Feb. 1, the CDC’s influenza division said.
Tests at clinical laboratories also show that predominance is continuing to switch from type B (45.6%) to type A (54.4%), the influenza division noted. Overall predominance for the season, however, continues to favor type B, 59.3% to 40.7%.
The percentage of deaths caused by pneumonia and influenza, which passed the threshold for epidemic of 7.2% back in early January, has been trending downward for the last 3 weeks and was 7.1% as of Feb. 1, according to the influenza division.
ILI-related deaths among children continue to remain high, with a total count of 78 for the season after another 10 deaths were reported during the week ending Feb. 1, the CDC reported. Comparable numbers for the last three seasons are 44 (2018-2019), 97 (2017-2018), and 35 (2016-2017).
The CDC estimates put the total number of ILIs at around 22 million for the season so far, leading to 210,000 hospitalizations. The agency said that it expects to release estimates of vaccine effectiveness later this month.
For the second time during the 2019-2020 flu season, activity measures have climbed into noteworthy territory.
The proportion of outpatient visits for influenza-like illness (ILI) reached its highest December level, 7.1%, since 2003 and then dropped for 2 weeks. Three weeks of increases since then, however, have the outpatient-visit rate at 6.7% for the week ending Feb. 1, 2020, the Centers for Disease Control and Prevention reported. The baseline rate for the United States is 2.4%.
That rate of 6.7% is already above the highest rates recorded in eight of the last nine flu seasons, and another increase could mean a second, separate trip above 7.0% in the 2019-2020 season – something that has not occurred since national tracking began in 1997, CDC data show.
Those same data also show that,
Another important measure on the rise, the proportion of respiratory specimens testing positive for influenza, reached a new high for the season, 29.8%, during the week of Feb. 1, the CDC’s influenza division said.
Tests at clinical laboratories also show that predominance is continuing to switch from type B (45.6%) to type A (54.4%), the influenza division noted. Overall predominance for the season, however, continues to favor type B, 59.3% to 40.7%.
The percentage of deaths caused by pneumonia and influenza, which passed the threshold for epidemic of 7.2% back in early January, has been trending downward for the last 3 weeks and was 7.1% as of Feb. 1, according to the influenza division.
ILI-related deaths among children continue to remain high, with a total count of 78 for the season after another 10 deaths were reported during the week ending Feb. 1, the CDC reported. Comparable numbers for the last three seasons are 44 (2018-2019), 97 (2017-2018), and 35 (2016-2017).
The CDC estimates put the total number of ILIs at around 22 million for the season so far, leading to 210,000 hospitalizations. The agency said that it expects to release estimates of vaccine effectiveness later this month.
For the second time during the 2019-2020 flu season, activity measures have climbed into noteworthy territory.
The proportion of outpatient visits for influenza-like illness (ILI) reached its highest December level, 7.1%, since 2003 and then dropped for 2 weeks. Three weeks of increases since then, however, have the outpatient-visit rate at 6.7% for the week ending Feb. 1, 2020, the Centers for Disease Control and Prevention reported. The baseline rate for the United States is 2.4%.
That rate of 6.7% is already above the highest rates recorded in eight of the last nine flu seasons, and another increase could mean a second, separate trip above 7.0% in the 2019-2020 season – something that has not occurred since national tracking began in 1997, CDC data show.
Those same data also show that,
Another important measure on the rise, the proportion of respiratory specimens testing positive for influenza, reached a new high for the season, 29.8%, during the week of Feb. 1, the CDC’s influenza division said.
Tests at clinical laboratories also show that predominance is continuing to switch from type B (45.6%) to type A (54.4%), the influenza division noted. Overall predominance for the season, however, continues to favor type B, 59.3% to 40.7%.
The percentage of deaths caused by pneumonia and influenza, which passed the threshold for epidemic of 7.2% back in early January, has been trending downward for the last 3 weeks and was 7.1% as of Feb. 1, according to the influenza division.
ILI-related deaths among children continue to remain high, with a total count of 78 for the season after another 10 deaths were reported during the week ending Feb. 1, the CDC reported. Comparable numbers for the last three seasons are 44 (2018-2019), 97 (2017-2018), and 35 (2016-2017).
The CDC estimates put the total number of ILIs at around 22 million for the season so far, leading to 210,000 hospitalizations. The agency said that it expects to release estimates of vaccine effectiveness later this month.
Remdesivir under study as treatment for novel coronavirus
“What they’re looking at is the effect of this drug -- either the drug plus standard of care versus standard of care alone,” Anthony S. Fauci, MD, reported Feb. 7 during a press briefing held by members of President Trump’s Coronavirus Task Force. “I think pretty soon we are going to get a definitive answer, whether one of these among several drugs works.”
Dr. Fauci, director of the National Institute of Allergy and Infectious Diseases, added that several organizations and individual investigators are developing vaccines for 2019-nCoV. In one such effort, the National Institutes of Health is working with Moderna Inc. to develop a vaccine built on a messenger RNA platform. “One of the first steps is to successfully get that [novel coronavirus] gene and insert it into the messenger RNA platform successfully and allow it to express proteins,” Dr. Fauci explained. “We’ve succeeded in that. The next [step] is to put it in a mouse animal model to induce immunogenicity, and to get the company to make [gold nanoparticle] products. All of those have been successfully implemented. There have been no glitches so far. If that continues, we will be in Phase 1 trials in people within the next two-and-a-half months.”
In another development on the same day, Robert R. Redfield, MD, director of the Centers for Disease Control and Prevention, announced that Heath & Human Services issued an interim final rule to amend foreign quarantine regulations in the wake of the public health threat posed by the 2019-nCoV. “This will enable CDC to collect certain contact information data regarding airline passengers and crew when they arrive from other countries. . .and may be exposed to communicable disease,” Dr. Redfield said. “This action is part of our multi-layered approach to the U.S. response and demonstrates our commitment to take all necessary actions to protect the American people.”
According to Alex Azar, secretary of Health and Human Services, and chair of President Trump’s Coronavirus Task Force, there are 12 confirmed cases of the novel coronavirus in the United States, including two cases of transmission to people who had not recently been in China. “Although the virus represents a potentially very serious public health threat, and we expect to continue seeing more cases here, the immediate risk to the American public is low at this time,” Mr. Azar said. “We are working as quickly as possible on the many unanswered questions about this virus. That includes exactly how it spreads, how deadly it is, whether it’s commonly transmitted by patients who are not yet displaying symptoms, and other issues.”
“What they’re looking at is the effect of this drug -- either the drug plus standard of care versus standard of care alone,” Anthony S. Fauci, MD, reported Feb. 7 during a press briefing held by members of President Trump’s Coronavirus Task Force. “I think pretty soon we are going to get a definitive answer, whether one of these among several drugs works.”
Dr. Fauci, director of the National Institute of Allergy and Infectious Diseases, added that several organizations and individual investigators are developing vaccines for 2019-nCoV. In one such effort, the National Institutes of Health is working with Moderna Inc. to develop a vaccine built on a messenger RNA platform. “One of the first steps is to successfully get that [novel coronavirus] gene and insert it into the messenger RNA platform successfully and allow it to express proteins,” Dr. Fauci explained. “We’ve succeeded in that. The next [step] is to put it in a mouse animal model to induce immunogenicity, and to get the company to make [gold nanoparticle] products. All of those have been successfully implemented. There have been no glitches so far. If that continues, we will be in Phase 1 trials in people within the next two-and-a-half months.”
In another development on the same day, Robert R. Redfield, MD, director of the Centers for Disease Control and Prevention, announced that Heath & Human Services issued an interim final rule to amend foreign quarantine regulations in the wake of the public health threat posed by the 2019-nCoV. “This will enable CDC to collect certain contact information data regarding airline passengers and crew when they arrive from other countries. . .and may be exposed to communicable disease,” Dr. Redfield said. “This action is part of our multi-layered approach to the U.S. response and demonstrates our commitment to take all necessary actions to protect the American people.”
According to Alex Azar, secretary of Health and Human Services, and chair of President Trump’s Coronavirus Task Force, there are 12 confirmed cases of the novel coronavirus in the United States, including two cases of transmission to people who had not recently been in China. “Although the virus represents a potentially very serious public health threat, and we expect to continue seeing more cases here, the immediate risk to the American public is low at this time,” Mr. Azar said. “We are working as quickly as possible on the many unanswered questions about this virus. That includes exactly how it spreads, how deadly it is, whether it’s commonly transmitted by patients who are not yet displaying symptoms, and other issues.”
“What they’re looking at is the effect of this drug -- either the drug plus standard of care versus standard of care alone,” Anthony S. Fauci, MD, reported Feb. 7 during a press briefing held by members of President Trump’s Coronavirus Task Force. “I think pretty soon we are going to get a definitive answer, whether one of these among several drugs works.”
Dr. Fauci, director of the National Institute of Allergy and Infectious Diseases, added that several organizations and individual investigators are developing vaccines for 2019-nCoV. In one such effort, the National Institutes of Health is working with Moderna Inc. to develop a vaccine built on a messenger RNA platform. “One of the first steps is to successfully get that [novel coronavirus] gene and insert it into the messenger RNA platform successfully and allow it to express proteins,” Dr. Fauci explained. “We’ve succeeded in that. The next [step] is to put it in a mouse animal model to induce immunogenicity, and to get the company to make [gold nanoparticle] products. All of those have been successfully implemented. There have been no glitches so far. If that continues, we will be in Phase 1 trials in people within the next two-and-a-half months.”
In another development on the same day, Robert R. Redfield, MD, director of the Centers for Disease Control and Prevention, announced that Heath & Human Services issued an interim final rule to amend foreign quarantine regulations in the wake of the public health threat posed by the 2019-nCoV. “This will enable CDC to collect certain contact information data regarding airline passengers and crew when they arrive from other countries. . .and may be exposed to communicable disease,” Dr. Redfield said. “This action is part of our multi-layered approach to the U.S. response and demonstrates our commitment to take all necessary actions to protect the American people.”
According to Alex Azar, secretary of Health and Human Services, and chair of President Trump’s Coronavirus Task Force, there are 12 confirmed cases of the novel coronavirus in the United States, including two cases of transmission to people who had not recently been in China. “Although the virus represents a potentially very serious public health threat, and we expect to continue seeing more cases here, the immediate risk to the American public is low at this time,” Mr. Azar said. “We are working as quickly as possible on the many unanswered questions about this virus. That includes exactly how it spreads, how deadly it is, whether it’s commonly transmitted by patients who are not yet displaying symptoms, and other issues.”
Fewer complications, better outcomes with outpatient UKA
according to a review from the University of Tennessee Campbell Clinic, Memphis.
“In carefully selected patients, the ASC [ambulatory surgery center] seems to be a safe alternative to the inpatient hospital setting,” concluded investigators led by led by Marcus Ford, MD, a Campbell Clinic orthopedic surgeon.
He and his colleagues have been doing outpatient unicompartmental knee arthroplasty (UKA) since 2009, and “based on the subjective success,” recently increased the number of total knee, hip, and shoulder arthroplasties performed in their ASC.
They wanted to make sure, however, that their impression of good outpatient UKA results was supported by the data, so they compared outcomes in 48 UKA patients treated at their ASC with 48 treated in the hospital. The operations were done by two surgeons using the same technique and same medial UKA implant.
“Naturally, surgeons select those patients who are deemed physically and mentally capable of succeeding with an accelerated discharge plan” for outpatient service, the investigators wrote. To address that potential selection bias, the team matched their subjects by age and comorbidities.
There was only one minor complication in the outpatient group, a superficial stitch abscess. No patient needed a second operation, and all went home the same day.
It was different on the inpatient side. The average length of stay was 2.9 days, and there were four major complications: a deep venous thrombosis, a pulmonary embolus, an acute postoperative infection, and a periprosthetic fracture. All four required hospital readmission, and two patients needed a second operation.
The report didn’t directly address the reasons for the differences, but Dr. Ford and colleagues did note that they “believe that the ASC allows the surgeon greater direct control of perioperative variables that can impact patient outcome.”
Patients were in their late 50s, on average, and there were more women than men in both groups. The mean American Society of Anesthesiologists physical status classification score was 1.94 and mean body mass index was 34.3 kg/m2 in the outpatient group, compared with a mean physical status classification score of 2.08 and mean body mass index of 32.9 kg/m2 in the inpatient group. The differences were not statistically significant.
No funding source was reported. The investigators did not report any disclosures.
SOURCE: Ford M et al. Orthop Clin North Am. 2020 Jan;51[1]:1-5. doi: 10.1016/j.ocl.2019.08.001
according to a review from the University of Tennessee Campbell Clinic, Memphis.
“In carefully selected patients, the ASC [ambulatory surgery center] seems to be a safe alternative to the inpatient hospital setting,” concluded investigators led by led by Marcus Ford, MD, a Campbell Clinic orthopedic surgeon.
He and his colleagues have been doing outpatient unicompartmental knee arthroplasty (UKA) since 2009, and “based on the subjective success,” recently increased the number of total knee, hip, and shoulder arthroplasties performed in their ASC.
They wanted to make sure, however, that their impression of good outpatient UKA results was supported by the data, so they compared outcomes in 48 UKA patients treated at their ASC with 48 treated in the hospital. The operations were done by two surgeons using the same technique and same medial UKA implant.
“Naturally, surgeons select those patients who are deemed physically and mentally capable of succeeding with an accelerated discharge plan” for outpatient service, the investigators wrote. To address that potential selection bias, the team matched their subjects by age and comorbidities.
There was only one minor complication in the outpatient group, a superficial stitch abscess. No patient needed a second operation, and all went home the same day.
It was different on the inpatient side. The average length of stay was 2.9 days, and there were four major complications: a deep venous thrombosis, a pulmonary embolus, an acute postoperative infection, and a periprosthetic fracture. All four required hospital readmission, and two patients needed a second operation.
The report didn’t directly address the reasons for the differences, but Dr. Ford and colleagues did note that they “believe that the ASC allows the surgeon greater direct control of perioperative variables that can impact patient outcome.”
Patients were in their late 50s, on average, and there were more women than men in both groups. The mean American Society of Anesthesiologists physical status classification score was 1.94 and mean body mass index was 34.3 kg/m2 in the outpatient group, compared with a mean physical status classification score of 2.08 and mean body mass index of 32.9 kg/m2 in the inpatient group. The differences were not statistically significant.
No funding source was reported. The investigators did not report any disclosures.
SOURCE: Ford M et al. Orthop Clin North Am. 2020 Jan;51[1]:1-5. doi: 10.1016/j.ocl.2019.08.001
according to a review from the University of Tennessee Campbell Clinic, Memphis.
“In carefully selected patients, the ASC [ambulatory surgery center] seems to be a safe alternative to the inpatient hospital setting,” concluded investigators led by led by Marcus Ford, MD, a Campbell Clinic orthopedic surgeon.
He and his colleagues have been doing outpatient unicompartmental knee arthroplasty (UKA) since 2009, and “based on the subjective success,” recently increased the number of total knee, hip, and shoulder arthroplasties performed in their ASC.
They wanted to make sure, however, that their impression of good outpatient UKA results was supported by the data, so they compared outcomes in 48 UKA patients treated at their ASC with 48 treated in the hospital. The operations were done by two surgeons using the same technique and same medial UKA implant.
“Naturally, surgeons select those patients who are deemed physically and mentally capable of succeeding with an accelerated discharge plan” for outpatient service, the investigators wrote. To address that potential selection bias, the team matched their subjects by age and comorbidities.
There was only one minor complication in the outpatient group, a superficial stitch abscess. No patient needed a second operation, and all went home the same day.
It was different on the inpatient side. The average length of stay was 2.9 days, and there were four major complications: a deep venous thrombosis, a pulmonary embolus, an acute postoperative infection, and a periprosthetic fracture. All four required hospital readmission, and two patients needed a second operation.
The report didn’t directly address the reasons for the differences, but Dr. Ford and colleagues did note that they “believe that the ASC allows the surgeon greater direct control of perioperative variables that can impact patient outcome.”
Patients were in their late 50s, on average, and there were more women than men in both groups. The mean American Society of Anesthesiologists physical status classification score was 1.94 and mean body mass index was 34.3 kg/m2 in the outpatient group, compared with a mean physical status classification score of 2.08 and mean body mass index of 32.9 kg/m2 in the inpatient group. The differences were not statistically significant.
No funding source was reported. The investigators did not report any disclosures.
SOURCE: Ford M et al. Orthop Clin North Am. 2020 Jan;51[1]:1-5. doi: 10.1016/j.ocl.2019.08.001
FROM ORTHOPEDIC CLINICS OF NORTH AMERICA
‘Antibacterial’ soap labels still list banned ingredients
The website of retail pharmacy giant Walgreens, for example, lists Dial Complete antibacterial soap with the active ingredient triclosan, a chemical the Food and Drug Administration banned along with others in 2017. The agency cited a lack of evidence that the ingredients were more effective than plain soap and water and that they were safe for long-term daily use.
A Dial Complete soap product page on Walgreens’ website lists, as of Feb. 4, 2020, an ingredient that was banned by the FDA.
Yet banned substances such as the triclosan in this Dial soap still commonly appear on online product descriptions, researchers found after searching the National Drug Code Directory and the websites of major online retailers, including Amazon, Walmart, and Target. The health effects of antibacterial ingredients “are very poorly defined,” said Chandler Rundle, MD, first author of the study, which was published in Dermatitis. Dr. Rundle is with the department of dermatology at the University of Colorado at Denver, Aurora.
The label on the back of the Dial soap bottle sold on Walgreens.com states that it “[k]ills more bacteria than ordinary liquid hand soap.” The website displays a close-up graphic of a hand that has been washed with Dial soap and that has fewer bacteria than a hand washed with “Others.” The graphic includes a dramatization disclaimer.
When asked about the product, a Walgreens corporate relations spokesperson checked the soap’s ingredients list they had on file from Dial’s parent company, Henkel North American Consumer Goods.
“I did not see that particular ingredient,” the representative said. Their ingredients list reflected a version of the soap that was updated after the ban. That label differs from Walgreens.com’s product information. The updated, ban-compliant version of the soap contains an alternative antibacterial compound, benzalkonium chloride. The spokesperson wasn’t sure of the source of the incorrect information on the website. Dial did not respond to a request for comment.
The ingredients list for Dial Complete soap on Walgreens.com shows FDA-banned triclosan as the active ingredient.
The 2017 FDA ban restricted the marketing of triclosan and triclocarban along with 17 other ingredients in consumer antibacterial soaps because manufacturers did not provide sufficient data to demonstrate that the ingredients were safe and effective, according to the FDA’s announcement. Independent research also showed that some ingredients worked no better than traditional soap and could create antibacterial-resistant microbes. Regular hand soap “still kills bacteria,” Dr. Rundle said. “The inclusion of an antibacterial substance does not make it better.”
Retailers (such as Walgreens) aren’t required to update their products’ online ingredient lists, which can pose a challenge for people who suffer from skin allergies, said Dr. Rundle. People at risk of having a reaction must read labels to verify the ingredients that are included.
Consumer antibacterial soap products that contain the banned compounds have largely been replaced with stand-ins, such as benzalkonium chloride and chloroxylenol, according to Dr. Rundle’s study. He and other researchers are trying to determine whether those compounds have the same shortcomings. “We’re talking 10-20 years down the line, and we’re worried about things like antibacterial resistance and systemic effects,” Dr. Rundle said.
The FDA has considered a ban on benzalkonium chloride and additional antibacterial ingredients, but in 2016, it granted ban deferrals, pending more research. The agency exchanged letters with the American Cleaning Institute (ACI), a trade association that represents companies, including Henkel. The FDA required that its companies fund research to show that the new antibacterial ingredients are safe and effective. The FDA granted subsequent annual extensions in 2017, 2018, and, most recently, in August 2019 to allow continued research into whether several ingredients are effective in soaps. In its most recent letter to the ACI, the FDA gave a checklist of research tasks to be submitted by July 2020.
The letter from August 2019 stated that the ACI, in its March 2019 progress report, failed to address milestones in studies of health care personnel handwashing for two of the substances. It also referenced the ACI’s lack of funding for the studies and reminded the organization that further deferrals would not be granted unless the ACI can show ongoing progress.
The ACI plans to meet with the FDA to have an in-depth discussion, Brian Sansoni, a spokesperson for the ACI, told Medscape Medical News. The ACI plans to give the FDA data that show the effectiveness of these ingredients over the course of several years, “due to the complexity of what FDA is asking for,” Mr. Sansoni said. “We’re working as diligently as possible to meet FDA requests.”
This article first appeared on Medscape.com.
The website of retail pharmacy giant Walgreens, for example, lists Dial Complete antibacterial soap with the active ingredient triclosan, a chemical the Food and Drug Administration banned along with others in 2017. The agency cited a lack of evidence that the ingredients were more effective than plain soap and water and that they were safe for long-term daily use.
A Dial Complete soap product page on Walgreens’ website lists, as of Feb. 4, 2020, an ingredient that was banned by the FDA.
Yet banned substances such as the triclosan in this Dial soap still commonly appear on online product descriptions, researchers found after searching the National Drug Code Directory and the websites of major online retailers, including Amazon, Walmart, and Target. The health effects of antibacterial ingredients “are very poorly defined,” said Chandler Rundle, MD, first author of the study, which was published in Dermatitis. Dr. Rundle is with the department of dermatology at the University of Colorado at Denver, Aurora.
The label on the back of the Dial soap bottle sold on Walgreens.com states that it “[k]ills more bacteria than ordinary liquid hand soap.” The website displays a close-up graphic of a hand that has been washed with Dial soap and that has fewer bacteria than a hand washed with “Others.” The graphic includes a dramatization disclaimer.
When asked about the product, a Walgreens corporate relations spokesperson checked the soap’s ingredients list they had on file from Dial’s parent company, Henkel North American Consumer Goods.
“I did not see that particular ingredient,” the representative said. Their ingredients list reflected a version of the soap that was updated after the ban. That label differs from Walgreens.com’s product information. The updated, ban-compliant version of the soap contains an alternative antibacterial compound, benzalkonium chloride. The spokesperson wasn’t sure of the source of the incorrect information on the website. Dial did not respond to a request for comment.
The ingredients list for Dial Complete soap on Walgreens.com shows FDA-banned triclosan as the active ingredient.
The 2017 FDA ban restricted the marketing of triclosan and triclocarban along with 17 other ingredients in consumer antibacterial soaps because manufacturers did not provide sufficient data to demonstrate that the ingredients were safe and effective, according to the FDA’s announcement. Independent research also showed that some ingredients worked no better than traditional soap and could create antibacterial-resistant microbes. Regular hand soap “still kills bacteria,” Dr. Rundle said. “The inclusion of an antibacterial substance does not make it better.”
Retailers (such as Walgreens) aren’t required to update their products’ online ingredient lists, which can pose a challenge for people who suffer from skin allergies, said Dr. Rundle. People at risk of having a reaction must read labels to verify the ingredients that are included.
Consumer antibacterial soap products that contain the banned compounds have largely been replaced with stand-ins, such as benzalkonium chloride and chloroxylenol, according to Dr. Rundle’s study. He and other researchers are trying to determine whether those compounds have the same shortcomings. “We’re talking 10-20 years down the line, and we’re worried about things like antibacterial resistance and systemic effects,” Dr. Rundle said.
The FDA has considered a ban on benzalkonium chloride and additional antibacterial ingredients, but in 2016, it granted ban deferrals, pending more research. The agency exchanged letters with the American Cleaning Institute (ACI), a trade association that represents companies, including Henkel. The FDA required that its companies fund research to show that the new antibacterial ingredients are safe and effective. The FDA granted subsequent annual extensions in 2017, 2018, and, most recently, in August 2019 to allow continued research into whether several ingredients are effective in soaps. In its most recent letter to the ACI, the FDA gave a checklist of research tasks to be submitted by July 2020.
The letter from August 2019 stated that the ACI, in its March 2019 progress report, failed to address milestones in studies of health care personnel handwashing for two of the substances. It also referenced the ACI’s lack of funding for the studies and reminded the organization that further deferrals would not be granted unless the ACI can show ongoing progress.
The ACI plans to meet with the FDA to have an in-depth discussion, Brian Sansoni, a spokesperson for the ACI, told Medscape Medical News. The ACI plans to give the FDA data that show the effectiveness of these ingredients over the course of several years, “due to the complexity of what FDA is asking for,” Mr. Sansoni said. “We’re working as diligently as possible to meet FDA requests.”
This article first appeared on Medscape.com.
The website of retail pharmacy giant Walgreens, for example, lists Dial Complete antibacterial soap with the active ingredient triclosan, a chemical the Food and Drug Administration banned along with others in 2017. The agency cited a lack of evidence that the ingredients were more effective than plain soap and water and that they were safe for long-term daily use.
A Dial Complete soap product page on Walgreens’ website lists, as of Feb. 4, 2020, an ingredient that was banned by the FDA.
Yet banned substances such as the triclosan in this Dial soap still commonly appear on online product descriptions, researchers found after searching the National Drug Code Directory and the websites of major online retailers, including Amazon, Walmart, and Target. The health effects of antibacterial ingredients “are very poorly defined,” said Chandler Rundle, MD, first author of the study, which was published in Dermatitis. Dr. Rundle is with the department of dermatology at the University of Colorado at Denver, Aurora.
The label on the back of the Dial soap bottle sold on Walgreens.com states that it “[k]ills more bacteria than ordinary liquid hand soap.” The website displays a close-up graphic of a hand that has been washed with Dial soap and that has fewer bacteria than a hand washed with “Others.” The graphic includes a dramatization disclaimer.
When asked about the product, a Walgreens corporate relations spokesperson checked the soap’s ingredients list they had on file from Dial’s parent company, Henkel North American Consumer Goods.
“I did not see that particular ingredient,” the representative said. Their ingredients list reflected a version of the soap that was updated after the ban. That label differs from Walgreens.com’s product information. The updated, ban-compliant version of the soap contains an alternative antibacterial compound, benzalkonium chloride. The spokesperson wasn’t sure of the source of the incorrect information on the website. Dial did not respond to a request for comment.
The ingredients list for Dial Complete soap on Walgreens.com shows FDA-banned triclosan as the active ingredient.
The 2017 FDA ban restricted the marketing of triclosan and triclocarban along with 17 other ingredients in consumer antibacterial soaps because manufacturers did not provide sufficient data to demonstrate that the ingredients were safe and effective, according to the FDA’s announcement. Independent research also showed that some ingredients worked no better than traditional soap and could create antibacterial-resistant microbes. Regular hand soap “still kills bacteria,” Dr. Rundle said. “The inclusion of an antibacterial substance does not make it better.”
Retailers (such as Walgreens) aren’t required to update their products’ online ingredient lists, which can pose a challenge for people who suffer from skin allergies, said Dr. Rundle. People at risk of having a reaction must read labels to verify the ingredients that are included.
Consumer antibacterial soap products that contain the banned compounds have largely been replaced with stand-ins, such as benzalkonium chloride and chloroxylenol, according to Dr. Rundle’s study. He and other researchers are trying to determine whether those compounds have the same shortcomings. “We’re talking 10-20 years down the line, and we’re worried about things like antibacterial resistance and systemic effects,” Dr. Rundle said.
The FDA has considered a ban on benzalkonium chloride and additional antibacterial ingredients, but in 2016, it granted ban deferrals, pending more research. The agency exchanged letters with the American Cleaning Institute (ACI), a trade association that represents companies, including Henkel. The FDA required that its companies fund research to show that the new antibacterial ingredients are safe and effective. The FDA granted subsequent annual extensions in 2017, 2018, and, most recently, in August 2019 to allow continued research into whether several ingredients are effective in soaps. In its most recent letter to the ACI, the FDA gave a checklist of research tasks to be submitted by July 2020.
The letter from August 2019 stated that the ACI, in its March 2019 progress report, failed to address milestones in studies of health care personnel handwashing for two of the substances. It also referenced the ACI’s lack of funding for the studies and reminded the organization that further deferrals would not be granted unless the ACI can show ongoing progress.
The ACI plans to meet with the FDA to have an in-depth discussion, Brian Sansoni, a spokesperson for the ACI, told Medscape Medical News. The ACI plans to give the FDA data that show the effectiveness of these ingredients over the course of several years, “due to the complexity of what FDA is asking for,” Mr. Sansoni said. “We’re working as diligently as possible to meet FDA requests.”
This article first appeared on Medscape.com.
Delaying flu vaccine didn’t drop fever rate for childhood immunizations
according to a randomized trial.
An increased risk for febrile seizures had been seen when the three vaccines were administered together, wrote Emmanuel B. Walter, MD, MPH, and coauthors, so they constructed a trial that compared a simultaneous administration strategy that delayed inactivated influenza vaccine (IIV) administration by about 2 weeks.
In all, 221 children aged 12-16 months were enrolled in the randomized study. A total of 110 children received quadrivalent IIV (IIV4), DTaP, and 13-valent pneumococcal conjugate vaccine (PCV13) simultaneously and returned for a dental health education visit 2 weeks later. For 111 children, DTaP and PCV13 were administered at study visit 1, and IIV4 was given along with dental health education 2 weeks later. Most children in both groups also received at least one nonstudy vaccine at the first study visit. Eleven children in the simultaneous group and four in the sequential group didn’t complete the study.
There was no difference between study groups in the combined rates of fever on the first 2 days after study visits 1 and 2 taken together: 8% of children in the simultaneous group and 9% of those in the sequential group had fever of 38° C or higher (adjusted relative risk, 0.87; 95% confidence interval, 0.36-2.10).
However, children in the simultaneous group were more likely to receive antipyretic medication in the first 2 days after visit 1 (37% versus 22%; P = .020), reported Dr. Walter, professor of pediatrics at Duke University, Durham, N.C., and coauthors. Because it’s rare for febrile seizures to occur after immunization, the authors didn’t make the occurrence of febrile seizure a primary or secondary endpoint of the study; no seizures occurred in study participants. They did hypothesize that the total proportion of children having fever would be higher in the simultaneous than in the sequential group – a hypothesis not supported by the study findings.
Children were excluded, or their study vaccinations were delayed, if they had received antipyretic medication within the 72 hours preceding the visit or at the study visit, or if they had a temperature of 38° C or more.
Parents monitored participants’ temperatures for 8 days after visits by using a study-provided temporal thermometer once daily at about the same time, and also by checking the temperature if their child felt feverish. Parents also recorded any antipyretic use, medical care, other symptoms, and febrile seizures.
The study was stopped earlier than anticipated because unexpectedly high levels of influenza activity made it unethical to delay influenza immunization, explained Dr. Walter and coauthors.
Participants were a median 15 months old; most were non-Hispanic white and had private insurance. Most participants didn’t attend day care.
“Nearly all fever episodes and days of fever on days 1-2 after the study visits occurred after visit 1,” reported Dr. Walter and coinvestigators. They saw no difference between groups in the proportion of children who had a fever of 38.6° C on days 1-2 after either study visit.
The mean peak temperature – about 38.5° C – on combined study visits 1 and 2 didn’t differ between groups. Similarly, for those participants who had a fever, the mean postvisit fever duration of 1.3 days was identical between groups.
Parents also were asked about their perceptions of the vaccination schedule their children received. Over half of parents overall (56%) reported that they disliked having to bring their child in for two separate clinic visits, with more parents in the sequential group than the simultaneous group reporting this (65% versus 48%).
Generalizability of the findings and comparison with previous studies are limited, noted Dr. Walter and coinvestigators, because the composition of influenza vaccine varies from year to year. No signal for seizures was seen in the Vaccine Safety Datalink after IIV during the 2017-2018 influenza season, wrote the investigators. The 2010-2011 influenza season’s IIV formulation was associated with increased febrile seizure risk, indicating that the IIV formulation for that year may have been more pyrogenic than the 2017-2018 formulation.
Also, children deemed at higher risk of febrile seizure were excluded from the study, so findings may have limited applicability to these children. The lack of parental blinding also may have influenced antipyretic administration or other symptom reporting, although objective temperature measurement should not have been affected by the lack of blinding, wrote Dr. Walker and collaborators.
The study was funded by the Centers for Disease Control and Prevention. One coauthor reported potential conflicts of interest from financial support received from GlaxoSmithKline, Sanofi Pasteur, Pfizer, Merck, Protein Science, Dynavax, and Medimmune. The remaining authors have no relevant financial disclosures.
SOURCE: Walter EB et al. Pediatrics. 2020;145(3):e20191909.
according to a randomized trial.
An increased risk for febrile seizures had been seen when the three vaccines were administered together, wrote Emmanuel B. Walter, MD, MPH, and coauthors, so they constructed a trial that compared a simultaneous administration strategy that delayed inactivated influenza vaccine (IIV) administration by about 2 weeks.
In all, 221 children aged 12-16 months were enrolled in the randomized study. A total of 110 children received quadrivalent IIV (IIV4), DTaP, and 13-valent pneumococcal conjugate vaccine (PCV13) simultaneously and returned for a dental health education visit 2 weeks later. For 111 children, DTaP and PCV13 were administered at study visit 1, and IIV4 was given along with dental health education 2 weeks later. Most children in both groups also received at least one nonstudy vaccine at the first study visit. Eleven children in the simultaneous group and four in the sequential group didn’t complete the study.
There was no difference between study groups in the combined rates of fever on the first 2 days after study visits 1 and 2 taken together: 8% of children in the simultaneous group and 9% of those in the sequential group had fever of 38° C or higher (adjusted relative risk, 0.87; 95% confidence interval, 0.36-2.10).
However, children in the simultaneous group were more likely to receive antipyretic medication in the first 2 days after visit 1 (37% versus 22%; P = .020), reported Dr. Walter, professor of pediatrics at Duke University, Durham, N.C., and coauthors. Because it’s rare for febrile seizures to occur after immunization, the authors didn’t make the occurrence of febrile seizure a primary or secondary endpoint of the study; no seizures occurred in study participants. They did hypothesize that the total proportion of children having fever would be higher in the simultaneous than in the sequential group – a hypothesis not supported by the study findings.
Children were excluded, or their study vaccinations were delayed, if they had received antipyretic medication within the 72 hours preceding the visit or at the study visit, or if they had a temperature of 38° C or more.
Parents monitored participants’ temperatures for 8 days after visits by using a study-provided temporal thermometer once daily at about the same time, and also by checking the temperature if their child felt feverish. Parents also recorded any antipyretic use, medical care, other symptoms, and febrile seizures.
The study was stopped earlier than anticipated because unexpectedly high levels of influenza activity made it unethical to delay influenza immunization, explained Dr. Walter and coauthors.
Participants were a median 15 months old; most were non-Hispanic white and had private insurance. Most participants didn’t attend day care.
“Nearly all fever episodes and days of fever on days 1-2 after the study visits occurred after visit 1,” reported Dr. Walter and coinvestigators. They saw no difference between groups in the proportion of children who had a fever of 38.6° C on days 1-2 after either study visit.
The mean peak temperature – about 38.5° C – on combined study visits 1 and 2 didn’t differ between groups. Similarly, for those participants who had a fever, the mean postvisit fever duration of 1.3 days was identical between groups.
Parents also were asked about their perceptions of the vaccination schedule their children received. Over half of parents overall (56%) reported that they disliked having to bring their child in for two separate clinic visits, with more parents in the sequential group than the simultaneous group reporting this (65% versus 48%).
Generalizability of the findings and comparison with previous studies are limited, noted Dr. Walter and coinvestigators, because the composition of influenza vaccine varies from year to year. No signal for seizures was seen in the Vaccine Safety Datalink after IIV during the 2017-2018 influenza season, wrote the investigators. The 2010-2011 influenza season’s IIV formulation was associated with increased febrile seizure risk, indicating that the IIV formulation for that year may have been more pyrogenic than the 2017-2018 formulation.
Also, children deemed at higher risk of febrile seizure were excluded from the study, so findings may have limited applicability to these children. The lack of parental blinding also may have influenced antipyretic administration or other symptom reporting, although objective temperature measurement should not have been affected by the lack of blinding, wrote Dr. Walker and collaborators.
The study was funded by the Centers for Disease Control and Prevention. One coauthor reported potential conflicts of interest from financial support received from GlaxoSmithKline, Sanofi Pasteur, Pfizer, Merck, Protein Science, Dynavax, and Medimmune. The remaining authors have no relevant financial disclosures.
SOURCE: Walter EB et al. Pediatrics. 2020;145(3):e20191909.
according to a randomized trial.
An increased risk for febrile seizures had been seen when the three vaccines were administered together, wrote Emmanuel B. Walter, MD, MPH, and coauthors, so they constructed a trial that compared a simultaneous administration strategy that delayed inactivated influenza vaccine (IIV) administration by about 2 weeks.
In all, 221 children aged 12-16 months were enrolled in the randomized study. A total of 110 children received quadrivalent IIV (IIV4), DTaP, and 13-valent pneumococcal conjugate vaccine (PCV13) simultaneously and returned for a dental health education visit 2 weeks later. For 111 children, DTaP and PCV13 were administered at study visit 1, and IIV4 was given along with dental health education 2 weeks later. Most children in both groups also received at least one nonstudy vaccine at the first study visit. Eleven children in the simultaneous group and four in the sequential group didn’t complete the study.
There was no difference between study groups in the combined rates of fever on the first 2 days after study visits 1 and 2 taken together: 8% of children in the simultaneous group and 9% of those in the sequential group had fever of 38° C or higher (adjusted relative risk, 0.87; 95% confidence interval, 0.36-2.10).
However, children in the simultaneous group were more likely to receive antipyretic medication in the first 2 days after visit 1 (37% versus 22%; P = .020), reported Dr. Walter, professor of pediatrics at Duke University, Durham, N.C., and coauthors. Because it’s rare for febrile seizures to occur after immunization, the authors didn’t make the occurrence of febrile seizure a primary or secondary endpoint of the study; no seizures occurred in study participants. They did hypothesize that the total proportion of children having fever would be higher in the simultaneous than in the sequential group – a hypothesis not supported by the study findings.
Children were excluded, or their study vaccinations were delayed, if they had received antipyretic medication within the 72 hours preceding the visit or at the study visit, or if they had a temperature of 38° C or more.
Parents monitored participants’ temperatures for 8 days after visits by using a study-provided temporal thermometer once daily at about the same time, and also by checking the temperature if their child felt feverish. Parents also recorded any antipyretic use, medical care, other symptoms, and febrile seizures.
The study was stopped earlier than anticipated because unexpectedly high levels of influenza activity made it unethical to delay influenza immunization, explained Dr. Walter and coauthors.
Participants were a median 15 months old; most were non-Hispanic white and had private insurance. Most participants didn’t attend day care.
“Nearly all fever episodes and days of fever on days 1-2 after the study visits occurred after visit 1,” reported Dr. Walter and coinvestigators. They saw no difference between groups in the proportion of children who had a fever of 38.6° C on days 1-2 after either study visit.
The mean peak temperature – about 38.5° C – on combined study visits 1 and 2 didn’t differ between groups. Similarly, for those participants who had a fever, the mean postvisit fever duration of 1.3 days was identical between groups.
Parents also were asked about their perceptions of the vaccination schedule their children received. Over half of parents overall (56%) reported that they disliked having to bring their child in for two separate clinic visits, with more parents in the sequential group than the simultaneous group reporting this (65% versus 48%).
Generalizability of the findings and comparison with previous studies are limited, noted Dr. Walter and coinvestigators, because the composition of influenza vaccine varies from year to year. No signal for seizures was seen in the Vaccine Safety Datalink after IIV during the 2017-2018 influenza season, wrote the investigators. The 2010-2011 influenza season’s IIV formulation was associated with increased febrile seizure risk, indicating that the IIV formulation for that year may have been more pyrogenic than the 2017-2018 formulation.
Also, children deemed at higher risk of febrile seizure were excluded from the study, so findings may have limited applicability to these children. The lack of parental blinding also may have influenced antipyretic administration or other symptom reporting, although objective temperature measurement should not have been affected by the lack of blinding, wrote Dr. Walker and collaborators.
The study was funded by the Centers for Disease Control and Prevention. One coauthor reported potential conflicts of interest from financial support received from GlaxoSmithKline, Sanofi Pasteur, Pfizer, Merck, Protein Science, Dynavax, and Medimmune. The remaining authors have no relevant financial disclosures.
SOURCE: Walter EB et al. Pediatrics. 2020;145(3):e20191909.
FROM PEDIATRICS
Key clinical point: Fevers were no less common when influenza vaccine was delayed for children receiving DTaP and pneumococcal vaccinations.
Major finding: There was no difference between study groups in the combined rates of fever on the first 2 days after study visits 1 and 2 taken together: 8% of children in the simultaneous group and 9% of those in the sequential group had fever of 38° C or higher (adjusted relative risk, 0.87).
Study details: Randomized, nonblinded trial of 221 children aged 12-16 months receiving scheduled vaccinations.
Disclosures: The study was funded by the Centers for Disease Control and Prevention. One coauthor reported financial support received from GlaxoSmithKline, Sanofi Pasteur, Pfizer, Merck, Protein Science, Dynavax, and Medimmune.
Source: Walter EB et al. Pediatrics. 2020;145(3):e20191909.
CDC begins coronavirus diagnostic test kit distribution; new case confirmed in Wisconsin
The Centers for Disease Control and Prevention and the Wisconsin Department of Health Services confirmed a new case of the 2019 Novel Coronavirus (2019-nCoV) on Feb. 5, 2020, bringing the total number of cases in the United States to 12.*
Earlier in the day, Nancy Messonnier, MD, director of the CDC National Center for Immunization and Respiratory Diseases, told reporters that 206 individuals under investigation had tested negative for infection with the novel virus and that tests were pending on another 76 individuals.
The agency also announced during a press briefing call that diagnostic test kits will begin shipping on Feb. 5, less than 24 hours after receiving an emergency use authorization from the Food and Drug Administration. Full information is available in an article published in the Morbidity and Mortality Weekly Report.
The emergency use authorization will allow for broader use of the CDC’s 2019-nCoV Real Time RT-PCR Diagnostic Panel, which to date has been limited for use at CDC laboratories. Under the emergency use authorization, the diagnostic kit is authorized for patients who meed the CDC criteria for 2019-nCoV testing. The diagnostic test is a reverse transcriptase polymerase chain reaction test that provides presumptive detection of 2019-nCoV from respiratory secretions, such as nasal or oral swabs. A positive test indicates likely infection, although a negative test does not preclude infection and should not be the sole determination for patient management decisions.
“Today, the test kits will start shipping to over 100 U.S. public health labs,” she said. “Each of these labs is required to perform international verification for [Clinical Laboratory Improvement Amendments] compliance prior to reporting out. This process is expected to take a few days.”
Dr. Messonnier said that 200 test kits will be distributed to domestic labs and another 200 test kits will go to select international labs. Each kit can perform diagnostics on 700-800 patient samples.
“What that means is that, by the start of next week, we expect there to be much enhanced capacity for laboratory testing closer to our patients,” she said, adding that additional test kits are being produced and will be available for ordering in the future. Each laboratory that places an order will receive one test kit.
“Distribution of these tests will improve the global capacity to detect and respond to this new virus,” Dr. Messonnier said. “Availability of this test is a starting place for greater commercial availability of diagnostic testing for nCoV.”
The CDC also said that the next batch of passengers arriving from Wuhan, China, will be arriving in one of four locations: Travis Air Force Base, Fairfield, Calif.; Marine Corps Air Station Miramar, San Diego; Lackland Air Force Base, San Antonio; and Eppley Airfield, Omaha, Neb. Passengers will be quarantined for up to 14 days from the day the flight left Wuhan and medical care will be provided if needed.
“We do not believe these people pose a threat to the communities where they are being housed as we are taking measures to minimize any contact,” she said, adding that confirmed infections are expected among these and other returning travelers.
Dr. Messonnier warned that the quarantine measures “may not catch every single returning traveler returning with novel coronavirus, given the nature of this virus and how it is spreading. But if we can catch the majority of them, that will slow the entry of this virus into the United States.”
*This story was updated on 02/05/2020.
The Centers for Disease Control and Prevention and the Wisconsin Department of Health Services confirmed a new case of the 2019 Novel Coronavirus (2019-nCoV) on Feb. 5, 2020, bringing the total number of cases in the United States to 12.*
Earlier in the day, Nancy Messonnier, MD, director of the CDC National Center for Immunization and Respiratory Diseases, told reporters that 206 individuals under investigation had tested negative for infection with the novel virus and that tests were pending on another 76 individuals.
The agency also announced during a press briefing call that diagnostic test kits will begin shipping on Feb. 5, less than 24 hours after receiving an emergency use authorization from the Food and Drug Administration. Full information is available in an article published in the Morbidity and Mortality Weekly Report.
The emergency use authorization will allow for broader use of the CDC’s 2019-nCoV Real Time RT-PCR Diagnostic Panel, which to date has been limited for use at CDC laboratories. Under the emergency use authorization, the diagnostic kit is authorized for patients who meed the CDC criteria for 2019-nCoV testing. The diagnostic test is a reverse transcriptase polymerase chain reaction test that provides presumptive detection of 2019-nCoV from respiratory secretions, such as nasal or oral swabs. A positive test indicates likely infection, although a negative test does not preclude infection and should not be the sole determination for patient management decisions.
“Today, the test kits will start shipping to over 100 U.S. public health labs,” she said. “Each of these labs is required to perform international verification for [Clinical Laboratory Improvement Amendments] compliance prior to reporting out. This process is expected to take a few days.”
Dr. Messonnier said that 200 test kits will be distributed to domestic labs and another 200 test kits will go to select international labs. Each kit can perform diagnostics on 700-800 patient samples.
“What that means is that, by the start of next week, we expect there to be much enhanced capacity for laboratory testing closer to our patients,” she said, adding that additional test kits are being produced and will be available for ordering in the future. Each laboratory that places an order will receive one test kit.
“Distribution of these tests will improve the global capacity to detect and respond to this new virus,” Dr. Messonnier said. “Availability of this test is a starting place for greater commercial availability of diagnostic testing for nCoV.”
The CDC also said that the next batch of passengers arriving from Wuhan, China, will be arriving in one of four locations: Travis Air Force Base, Fairfield, Calif.; Marine Corps Air Station Miramar, San Diego; Lackland Air Force Base, San Antonio; and Eppley Airfield, Omaha, Neb. Passengers will be quarantined for up to 14 days from the day the flight left Wuhan and medical care will be provided if needed.
“We do not believe these people pose a threat to the communities where they are being housed as we are taking measures to minimize any contact,” she said, adding that confirmed infections are expected among these and other returning travelers.
Dr. Messonnier warned that the quarantine measures “may not catch every single returning traveler returning with novel coronavirus, given the nature of this virus and how it is spreading. But if we can catch the majority of them, that will slow the entry of this virus into the United States.”
*This story was updated on 02/05/2020.
The Centers for Disease Control and Prevention and the Wisconsin Department of Health Services confirmed a new case of the 2019 Novel Coronavirus (2019-nCoV) on Feb. 5, 2020, bringing the total number of cases in the United States to 12.*
Earlier in the day, Nancy Messonnier, MD, director of the CDC National Center for Immunization and Respiratory Diseases, told reporters that 206 individuals under investigation had tested negative for infection with the novel virus and that tests were pending on another 76 individuals.
The agency also announced during a press briefing call that diagnostic test kits will begin shipping on Feb. 5, less than 24 hours after receiving an emergency use authorization from the Food and Drug Administration. Full information is available in an article published in the Morbidity and Mortality Weekly Report.
The emergency use authorization will allow for broader use of the CDC’s 2019-nCoV Real Time RT-PCR Diagnostic Panel, which to date has been limited for use at CDC laboratories. Under the emergency use authorization, the diagnostic kit is authorized for patients who meed the CDC criteria for 2019-nCoV testing. The diagnostic test is a reverse transcriptase polymerase chain reaction test that provides presumptive detection of 2019-nCoV from respiratory secretions, such as nasal or oral swabs. A positive test indicates likely infection, although a negative test does not preclude infection and should not be the sole determination for patient management decisions.
“Today, the test kits will start shipping to over 100 U.S. public health labs,” she said. “Each of these labs is required to perform international verification for [Clinical Laboratory Improvement Amendments] compliance prior to reporting out. This process is expected to take a few days.”
Dr. Messonnier said that 200 test kits will be distributed to domestic labs and another 200 test kits will go to select international labs. Each kit can perform diagnostics on 700-800 patient samples.
“What that means is that, by the start of next week, we expect there to be much enhanced capacity for laboratory testing closer to our patients,” she said, adding that additional test kits are being produced and will be available for ordering in the future. Each laboratory that places an order will receive one test kit.
“Distribution of these tests will improve the global capacity to detect and respond to this new virus,” Dr. Messonnier said. “Availability of this test is a starting place for greater commercial availability of diagnostic testing for nCoV.”
The CDC also said that the next batch of passengers arriving from Wuhan, China, will be arriving in one of four locations: Travis Air Force Base, Fairfield, Calif.; Marine Corps Air Station Miramar, San Diego; Lackland Air Force Base, San Antonio; and Eppley Airfield, Omaha, Neb. Passengers will be quarantined for up to 14 days from the day the flight left Wuhan and medical care will be provided if needed.
“We do not believe these people pose a threat to the communities where they are being housed as we are taking measures to minimize any contact,” she said, adding that confirmed infections are expected among these and other returning travelers.
Dr. Messonnier warned that the quarantine measures “may not catch every single returning traveler returning with novel coronavirus, given the nature of this virus and how it is spreading. But if we can catch the majority of them, that will slow the entry of this virus into the United States.”
*This story was updated on 02/05/2020.
The 2019 novel coronavirus: Case review IDs clinical characteristics
A group of physicians in Wuhan, China, who are treating patients with the 2019 novel coronavirus have gone the extra mile to share their clinical experiences with colleagues around the world.
Nanshan Chen, MD, of Jinyintan Hospital, Wuhan, and his team conducted a retrospective study on 99 cases and, in very short order, published their initial findings in the Lancet online on Jan. 29. These findings could guide action in other cases and help clinicians all over the world create treatment plans for patients of the 2019-nCoV.
The findings show that and characteristics of those with fatal infections align with the MuLBSTA score – an early warning model for predicting viral pneumonia–related mortality, according to a case review.
Of 99 patients who presented with 2019-nCoV pneumonia at Jinyintan Hospital between Jan. 1 and Jan. 20, 67 were men, the mean age was 55.5 years, and 50 patients had chronic diseases.
“All the data of included cases have been shared with [the World Health Organization]. The study was approved by Jinyintan Hospital Ethics Committee and written informed consent was obtained from patients involved before enrollment when data were collected retrospectively,” the researchers noted.
Nearly half of the patients (49%) lived or worked near a specific seafood market, suggesting disease clustering.
Clinical manifestations affecting the majority of patients included fever and cough in 83% and 82% of patients, respectively. Other symptoms included shortness of breath in 31%, muscle aches in 11%, confusion in 9%, headache in 8%, sore throat in 5%, and rhinorrhea, chest pain, diarrhea, and nausea and vomiting in 1%-4% of patients, the investigators found.
Imaging showed bilateral pneumonia in 75% of cases, multiple mottling and ground-glass opacity in 14%, and pneumothorax in 1%. Organ function damage was present in a third of patients at admission: 17% had acute respiratory distress syndrome (ARDS) – including 11 patients who worsened quickly and died of multiple organ failure. Eight percent had acute respiratory injury, 3% had acute renal injury, 4% had septic shock, and 1% had ventilator-associated pneumonia, they said, noting that all cases were confirmed by real-time polymerase chain reaction.
A notable laboratory finding was reduced absolute lymphocyte counts in most patients, the investigators said.
All patients were treated in isolation and 76% received antiviral treatment with oseltamivir, ganciclovir, lopinavir, or ritonavir for 3-14 days (median, 3 days). Most patients also received antibiotic treatment, including a single antibiotic in 25% of cases and combination therapy in 45%, with most antibiotics used to cover “common pathogens and some atypical pathogens,” they said, adding that “when secondary bacterial infection occurred, medication was administered according to the results of bacterial culture and drug sensitivity.”
Cephalosporins, quinolones, carbapenems, tigecycline against methicillin-resistant Staphylococcus aureus, linezolid, and antifungal drugs were used, and duration ranged from 3 to 17 days (median, 5 days).
Nineteen patients also received steroid treatments.
As of Jan. 25, 31 patients had been discharged and 57 remained hospitalized. Of the 11 who died, the first 2 were a 61-year-old man and a 69-year-old man, each diagnosed with severe pneumonia and ARDS. The first experienced sudden cardiac arrest and died on admission day 11, and the second died of severe pneumonia, septic shock, and respiratory failure on admission day 9. Neither had underlying disease, but both had a long history of smoking, the investigators noted.
“The deaths of these two patients were consistent with the MuLBSTA score,” they wrote, explaining that the scoring system takes into account multilobular infiltration, lymphopenia, bacterial coinfection, smoking history, hypertension, and age.
Eight of the nine other patients who died had lymphopenia, seven had bilateral pneumonia, five were over age 60 years, three had hypertension, and one was a heavy smoker, they added.
Most coronavirus infections cause mild symptoms and have good prognosis, but some patients with the 2019-nCoV, which was identified Jan. 7 following the development of several cases of pneumonia of unknown etiology in Wuhan, develop fatal disease. The paucity of data regarding epidemiology and clinical features of pneumonia associated with 2019-nCoV prompted the current retrospective study at the center where the first cases were admitted, the investigators explained.
They noted that the sequence of 2019-nCoV “is relatively different from the six other coronavirus subtypes, including the highly pathogenic severe acute respiratory syndrome (SARS)-CoV and Middle East Respiratory Syndrome (MERS)-CoV, as well as the human coronaviruses (HCoV)-OC43, -229E, -NL63, and -HKU1 that induce mild upper respiratory disease, but can be classified as a betacoronavirus with evidence of human-to-human transmission.
Mortality associated with SARS-CoV and MERS-CoV have been reported as more than 10% and more than 35%, respectively; at data cutoff for the current study, mortality among the 99 included cases was 11%, which is similar to that in another recent 2019-nCoV report, they said.
The finding of greater risk among older men also has been seen with SARS-CoV and MERS-CoV, and the high rate among individuals with chronic diseases, mainly cerebrovascular disease, cardiovascular disease, and diabetes, also has been reported with MERS-CoV, they added.
“Our results suggest that 2019-nCoV is more likely to infect older adult males with chronic comorbidities as a result of the weaker immune functions of these patients,” they wrote.
Coinfection with bacteria and fungi occurred in some patients, particularly those with severe illness, and cultures most often showed A. baumannii, K. pneumoniae, A. flavus, C. glabrata, and C. albicans, and the findings of reduced absolute lymphocyte values in most patients suggests that “2019-nCoV might mainly act on lymphocytes, especially T lymphocytes, as does SARS-CoV,” they noted.
Given the rapid progression with ARDS and septic shock in some patients in this review, “early identification and timely treatment of critical cases is of crucial importance,” they said.
“Use of intravenous immunoglobulin is recommended to enhance the ability of anti-infection for severely ill patients, and steroids (methylprednisolone 1-2 mg/kg per day) are recommended for patients with ARDS, for as short a duration of treatment as possible,” they added.
Further, since some studies suggest that a substantial decrease in lymphocyte count indicates consumption of many immune cells by coronavirus, thereby inhibiting cellular immune function, damage to T lymphocytes might be “an important factor leading to exacerbations of patients,” they wrote, adding that “[t]he low absolute value of lymphocytes could be used as a reference index in the diagnosis of new coronavirus infections in the clinic.”
The MuLBSTA score also should be investigated to determine its applicability for predicting mortality risk in patients with 2019-nCoV infection, they added.
The current study is limited by its small sample size; additional studies are needed to include “as many patients as possible in Wuhan, in other cities in China, and even in other countries to get a more comprehensive understanding of 2019-nCoV,” they said.
The National Key R&D Program of China funded the study. The authors reported having no conflicts of interest.
SOURCE: Chen N et al. Lancet. 2020 Jan 29. doi: 10.1016/S0140-6736(20)30211-7.
A group of physicians in Wuhan, China, who are treating patients with the 2019 novel coronavirus have gone the extra mile to share their clinical experiences with colleagues around the world.
Nanshan Chen, MD, of Jinyintan Hospital, Wuhan, and his team conducted a retrospective study on 99 cases and, in very short order, published their initial findings in the Lancet online on Jan. 29. These findings could guide action in other cases and help clinicians all over the world create treatment plans for patients of the 2019-nCoV.
The findings show that and characteristics of those with fatal infections align with the MuLBSTA score – an early warning model for predicting viral pneumonia–related mortality, according to a case review.
Of 99 patients who presented with 2019-nCoV pneumonia at Jinyintan Hospital between Jan. 1 and Jan. 20, 67 were men, the mean age was 55.5 years, and 50 patients had chronic diseases.
“All the data of included cases have been shared with [the World Health Organization]. The study was approved by Jinyintan Hospital Ethics Committee and written informed consent was obtained from patients involved before enrollment when data were collected retrospectively,” the researchers noted.
Nearly half of the patients (49%) lived or worked near a specific seafood market, suggesting disease clustering.
Clinical manifestations affecting the majority of patients included fever and cough in 83% and 82% of patients, respectively. Other symptoms included shortness of breath in 31%, muscle aches in 11%, confusion in 9%, headache in 8%, sore throat in 5%, and rhinorrhea, chest pain, diarrhea, and nausea and vomiting in 1%-4% of patients, the investigators found.
Imaging showed bilateral pneumonia in 75% of cases, multiple mottling and ground-glass opacity in 14%, and pneumothorax in 1%. Organ function damage was present in a third of patients at admission: 17% had acute respiratory distress syndrome (ARDS) – including 11 patients who worsened quickly and died of multiple organ failure. Eight percent had acute respiratory injury, 3% had acute renal injury, 4% had septic shock, and 1% had ventilator-associated pneumonia, they said, noting that all cases were confirmed by real-time polymerase chain reaction.
A notable laboratory finding was reduced absolute lymphocyte counts in most patients, the investigators said.
All patients were treated in isolation and 76% received antiviral treatment with oseltamivir, ganciclovir, lopinavir, or ritonavir for 3-14 days (median, 3 days). Most patients also received antibiotic treatment, including a single antibiotic in 25% of cases and combination therapy in 45%, with most antibiotics used to cover “common pathogens and some atypical pathogens,” they said, adding that “when secondary bacterial infection occurred, medication was administered according to the results of bacterial culture and drug sensitivity.”
Cephalosporins, quinolones, carbapenems, tigecycline against methicillin-resistant Staphylococcus aureus, linezolid, and antifungal drugs were used, and duration ranged from 3 to 17 days (median, 5 days).
Nineteen patients also received steroid treatments.
As of Jan. 25, 31 patients had been discharged and 57 remained hospitalized. Of the 11 who died, the first 2 were a 61-year-old man and a 69-year-old man, each diagnosed with severe pneumonia and ARDS. The first experienced sudden cardiac arrest and died on admission day 11, and the second died of severe pneumonia, septic shock, and respiratory failure on admission day 9. Neither had underlying disease, but both had a long history of smoking, the investigators noted.
“The deaths of these two patients were consistent with the MuLBSTA score,” they wrote, explaining that the scoring system takes into account multilobular infiltration, lymphopenia, bacterial coinfection, smoking history, hypertension, and age.
Eight of the nine other patients who died had lymphopenia, seven had bilateral pneumonia, five were over age 60 years, three had hypertension, and one was a heavy smoker, they added.
Most coronavirus infections cause mild symptoms and have good prognosis, but some patients with the 2019-nCoV, which was identified Jan. 7 following the development of several cases of pneumonia of unknown etiology in Wuhan, develop fatal disease. The paucity of data regarding epidemiology and clinical features of pneumonia associated with 2019-nCoV prompted the current retrospective study at the center where the first cases were admitted, the investigators explained.
They noted that the sequence of 2019-nCoV “is relatively different from the six other coronavirus subtypes, including the highly pathogenic severe acute respiratory syndrome (SARS)-CoV and Middle East Respiratory Syndrome (MERS)-CoV, as well as the human coronaviruses (HCoV)-OC43, -229E, -NL63, and -HKU1 that induce mild upper respiratory disease, but can be classified as a betacoronavirus with evidence of human-to-human transmission.
Mortality associated with SARS-CoV and MERS-CoV have been reported as more than 10% and more than 35%, respectively; at data cutoff for the current study, mortality among the 99 included cases was 11%, which is similar to that in another recent 2019-nCoV report, they said.
The finding of greater risk among older men also has been seen with SARS-CoV and MERS-CoV, and the high rate among individuals with chronic diseases, mainly cerebrovascular disease, cardiovascular disease, and diabetes, also has been reported with MERS-CoV, they added.
“Our results suggest that 2019-nCoV is more likely to infect older adult males with chronic comorbidities as a result of the weaker immune functions of these patients,” they wrote.
Coinfection with bacteria and fungi occurred in some patients, particularly those with severe illness, and cultures most often showed A. baumannii, K. pneumoniae, A. flavus, C. glabrata, and C. albicans, and the findings of reduced absolute lymphocyte values in most patients suggests that “2019-nCoV might mainly act on lymphocytes, especially T lymphocytes, as does SARS-CoV,” they noted.
Given the rapid progression with ARDS and septic shock in some patients in this review, “early identification and timely treatment of critical cases is of crucial importance,” they said.
“Use of intravenous immunoglobulin is recommended to enhance the ability of anti-infection for severely ill patients, and steroids (methylprednisolone 1-2 mg/kg per day) are recommended for patients with ARDS, for as short a duration of treatment as possible,” they added.
Further, since some studies suggest that a substantial decrease in lymphocyte count indicates consumption of many immune cells by coronavirus, thereby inhibiting cellular immune function, damage to T lymphocytes might be “an important factor leading to exacerbations of patients,” they wrote, adding that “[t]he low absolute value of lymphocytes could be used as a reference index in the diagnosis of new coronavirus infections in the clinic.”
The MuLBSTA score also should be investigated to determine its applicability for predicting mortality risk in patients with 2019-nCoV infection, they added.
The current study is limited by its small sample size; additional studies are needed to include “as many patients as possible in Wuhan, in other cities in China, and even in other countries to get a more comprehensive understanding of 2019-nCoV,” they said.
The National Key R&D Program of China funded the study. The authors reported having no conflicts of interest.
SOURCE: Chen N et al. Lancet. 2020 Jan 29. doi: 10.1016/S0140-6736(20)30211-7.
A group of physicians in Wuhan, China, who are treating patients with the 2019 novel coronavirus have gone the extra mile to share their clinical experiences with colleagues around the world.
Nanshan Chen, MD, of Jinyintan Hospital, Wuhan, and his team conducted a retrospective study on 99 cases and, in very short order, published their initial findings in the Lancet online on Jan. 29. These findings could guide action in other cases and help clinicians all over the world create treatment plans for patients of the 2019-nCoV.
The findings show that and characteristics of those with fatal infections align with the MuLBSTA score – an early warning model for predicting viral pneumonia–related mortality, according to a case review.
Of 99 patients who presented with 2019-nCoV pneumonia at Jinyintan Hospital between Jan. 1 and Jan. 20, 67 were men, the mean age was 55.5 years, and 50 patients had chronic diseases.
“All the data of included cases have been shared with [the World Health Organization]. The study was approved by Jinyintan Hospital Ethics Committee and written informed consent was obtained from patients involved before enrollment when data were collected retrospectively,” the researchers noted.
Nearly half of the patients (49%) lived or worked near a specific seafood market, suggesting disease clustering.
Clinical manifestations affecting the majority of patients included fever and cough in 83% and 82% of patients, respectively. Other symptoms included shortness of breath in 31%, muscle aches in 11%, confusion in 9%, headache in 8%, sore throat in 5%, and rhinorrhea, chest pain, diarrhea, and nausea and vomiting in 1%-4% of patients, the investigators found.
Imaging showed bilateral pneumonia in 75% of cases, multiple mottling and ground-glass opacity in 14%, and pneumothorax in 1%. Organ function damage was present in a third of patients at admission: 17% had acute respiratory distress syndrome (ARDS) – including 11 patients who worsened quickly and died of multiple organ failure. Eight percent had acute respiratory injury, 3% had acute renal injury, 4% had septic shock, and 1% had ventilator-associated pneumonia, they said, noting that all cases were confirmed by real-time polymerase chain reaction.
A notable laboratory finding was reduced absolute lymphocyte counts in most patients, the investigators said.
All patients were treated in isolation and 76% received antiviral treatment with oseltamivir, ganciclovir, lopinavir, or ritonavir for 3-14 days (median, 3 days). Most patients also received antibiotic treatment, including a single antibiotic in 25% of cases and combination therapy in 45%, with most antibiotics used to cover “common pathogens and some atypical pathogens,” they said, adding that “when secondary bacterial infection occurred, medication was administered according to the results of bacterial culture and drug sensitivity.”
Cephalosporins, quinolones, carbapenems, tigecycline against methicillin-resistant Staphylococcus aureus, linezolid, and antifungal drugs were used, and duration ranged from 3 to 17 days (median, 5 days).
Nineteen patients also received steroid treatments.
As of Jan. 25, 31 patients had been discharged and 57 remained hospitalized. Of the 11 who died, the first 2 were a 61-year-old man and a 69-year-old man, each diagnosed with severe pneumonia and ARDS. The first experienced sudden cardiac arrest and died on admission day 11, and the second died of severe pneumonia, septic shock, and respiratory failure on admission day 9. Neither had underlying disease, but both had a long history of smoking, the investigators noted.
“The deaths of these two patients were consistent with the MuLBSTA score,” they wrote, explaining that the scoring system takes into account multilobular infiltration, lymphopenia, bacterial coinfection, smoking history, hypertension, and age.
Eight of the nine other patients who died had lymphopenia, seven had bilateral pneumonia, five were over age 60 years, three had hypertension, and one was a heavy smoker, they added.
Most coronavirus infections cause mild symptoms and have good prognosis, but some patients with the 2019-nCoV, which was identified Jan. 7 following the development of several cases of pneumonia of unknown etiology in Wuhan, develop fatal disease. The paucity of data regarding epidemiology and clinical features of pneumonia associated with 2019-nCoV prompted the current retrospective study at the center where the first cases were admitted, the investigators explained.
They noted that the sequence of 2019-nCoV “is relatively different from the six other coronavirus subtypes, including the highly pathogenic severe acute respiratory syndrome (SARS)-CoV and Middle East Respiratory Syndrome (MERS)-CoV, as well as the human coronaviruses (HCoV)-OC43, -229E, -NL63, and -HKU1 that induce mild upper respiratory disease, but can be classified as a betacoronavirus with evidence of human-to-human transmission.
Mortality associated with SARS-CoV and MERS-CoV have been reported as more than 10% and more than 35%, respectively; at data cutoff for the current study, mortality among the 99 included cases was 11%, which is similar to that in another recent 2019-nCoV report, they said.
The finding of greater risk among older men also has been seen with SARS-CoV and MERS-CoV, and the high rate among individuals with chronic diseases, mainly cerebrovascular disease, cardiovascular disease, and diabetes, also has been reported with MERS-CoV, they added.
“Our results suggest that 2019-nCoV is more likely to infect older adult males with chronic comorbidities as a result of the weaker immune functions of these patients,” they wrote.
Coinfection with bacteria and fungi occurred in some patients, particularly those with severe illness, and cultures most often showed A. baumannii, K. pneumoniae, A. flavus, C. glabrata, and C. albicans, and the findings of reduced absolute lymphocyte values in most patients suggests that “2019-nCoV might mainly act on lymphocytes, especially T lymphocytes, as does SARS-CoV,” they noted.
Given the rapid progression with ARDS and septic shock in some patients in this review, “early identification and timely treatment of critical cases is of crucial importance,” they said.
“Use of intravenous immunoglobulin is recommended to enhance the ability of anti-infection for severely ill patients, and steroids (methylprednisolone 1-2 mg/kg per day) are recommended for patients with ARDS, for as short a duration of treatment as possible,” they added.
Further, since some studies suggest that a substantial decrease in lymphocyte count indicates consumption of many immune cells by coronavirus, thereby inhibiting cellular immune function, damage to T lymphocytes might be “an important factor leading to exacerbations of patients,” they wrote, adding that “[t]he low absolute value of lymphocytes could be used as a reference index in the diagnosis of new coronavirus infections in the clinic.”
The MuLBSTA score also should be investigated to determine its applicability for predicting mortality risk in patients with 2019-nCoV infection, they added.
The current study is limited by its small sample size; additional studies are needed to include “as many patients as possible in Wuhan, in other cities in China, and even in other countries to get a more comprehensive understanding of 2019-nCoV,” they said.
The National Key R&D Program of China funded the study. The authors reported having no conflicts of interest.
SOURCE: Chen N et al. Lancet. 2020 Jan 29. doi: 10.1016/S0140-6736(20)30211-7.
FROM THE LANCET
Measles, scarlet fever among infectious diseases to watch for in 2020
ORLANDO – – leading into 2020, Justin Finch, MD, said at the ODAC Dermatology, Aesthetic, & Surgical Conference.
While group A streptococcus has declined over the past century, there has been “an unprecedented” resurgence in severe, invasive group A streptococcal infections and severe epidemics of scarlet fever worldwide, including in industrialized regions like the United Kingdom. Shedding some light on why this may be occurring, Dr. Finch referred to a recently published population-based molecular epidemiologic study identified a new dominant emm1UK lineage of Streptococcus pyogenes associated with such cases in England (Lancet Infect Dis. 2019 Nov;19(11):1209-18). This new lineage of S. pyogenes was genotypically distinct from other emm1 isolates and had greatly increased expression of the streptococcal pyrogenic exotoxin A, one of the exotoxins responsible for the clinical features of scarlet fever.
“We have not, to my knowledge, seen the strain yet in the United States,” said Dr. Finch, of Central Connecticut Dermatology in Cromwell. “Have it on your radar. With all of the worldwide travel patterns, I expect that you will see this in the United States at some point in the not-too-distant future.”
Also in 2019, promising data on the safety and effectiveness of the recombinant herpes zoster vaccine in immunocompromised patients became available for the first time. A randomized clinical trial published in JAMA of 1,846 patients who were immunosuppressed after autologous hematopoietic stem cell transplantation and received two doses of a recombinant zoster vaccine found that the patients had a reduced incidence of herpes zoster after a median follow-up of 21 months (JAMA. 2019 Jul 9;322[2]:123-33). The study found that the recombinant vaccine was both safe and effective in these immunocompromised patients, “so we can easily generalize this to our dermatology population as well,” Dr. Finch said. In comparing the live attenuated and recombinant vaccines, he noted the recombinant vaccine requires two doses but appears to be slightly more effective. “The number needed to treat to prevent [one case] of zoster is about half as high as that for the live vaccine, and most importantly for us is, it’s safe in immunocompromised patients.”
2019 also saw a record high in the number of measles cases in the United States, the highest since 1993, Dr. Finch pointed out. Most cases were seen in the area in and around New York City, but the percentage of people across the United States who are vaccinated against measles is below the threshold for herd immunity to protect immunocompromised patients. Measles requires a population vaccination rate of 94%, and less than half of U.S. counties in 2014 and 2015 reached that vaccination rate.
“Furthermore, if we look at that over the last 20 years, comparing the domestic measles cases to imported measles cases, we are increasingly breeding these measles epidemics right here at home, whereas they used to be imported from throughout the world,” said Dr. Finch. Patients with measles can be treated with vitamin A, he added, referring to a Cochrane review showing that 200,000 units of vitamin A given daily for 2 days decreased the mortality rate of measles by about 80%. Measles is on the Centers for Disease Control and Prevention’s list of reportable diseases, so should be reported to local health authorities, and will be followed up with confirmatory testing.
In 2019, a study examining herd protection of oral human papillomavirus infection in men and women compared the prevalence of oral HPV infection based on the 4 HPV types present in the quadrivalent HPV vaccine with 33 nonvaccine types from 2009 to 2016. There was no change in the prevalence of nonvaccine type oral HPV infections among men who were unvaccinated, but the prevalence of oral HPV infections because of the four strains in the quadrivalent HPV vaccine declined from 2.7% in 2009-2010 to 1.6% in 2015-2016 (JAMA. 2019 Sep 10;322[10]:977-9). Among unvaccinated women, the prevalence of nonvaccine- and vaccine-type oral HPV infections did not change between the two time periods.
“Notably, this only occurred in men,” Dr. Finch said. Herd immunity is being achieved in men “because we’re vaccinating all women, [but] we’re not seeing that herd immunity in women. Which begs the question: Why are we still vaccinating only half of our population?”
One study published in 2019 (Br J Dermatol. 2019 Nov;181[5]:1093-5) described a patient with CARD9 mutations, which predispose individuals to deep invasive infections – a disseminated Microsporum infection in this case, Dr. Finch said. “You shouldn’t see that,” he added, noting that these mutations are known to predispose individuals to severe Trichophyton infections and familial candidiasis.
“What I think is interesting about this is that, as we look forward to 2020, we’re going to increasingly see studies like this that are identifying specific mutations in our community that underlie a lot of these weird infections,” he added. “I wouldn’t be surprised if within the span of our careers, we find that a lot of those severe treatment-refractory reports that so commonly plague your everyday clinic have some underlying, specific immunity.”
Dr. Finch reported no relevant conflicts of interest.
ORLANDO – – leading into 2020, Justin Finch, MD, said at the ODAC Dermatology, Aesthetic, & Surgical Conference.
While group A streptococcus has declined over the past century, there has been “an unprecedented” resurgence in severe, invasive group A streptococcal infections and severe epidemics of scarlet fever worldwide, including in industrialized regions like the United Kingdom. Shedding some light on why this may be occurring, Dr. Finch referred to a recently published population-based molecular epidemiologic study identified a new dominant emm1UK lineage of Streptococcus pyogenes associated with such cases in England (Lancet Infect Dis. 2019 Nov;19(11):1209-18). This new lineage of S. pyogenes was genotypically distinct from other emm1 isolates and had greatly increased expression of the streptococcal pyrogenic exotoxin A, one of the exotoxins responsible for the clinical features of scarlet fever.
“We have not, to my knowledge, seen the strain yet in the United States,” said Dr. Finch, of Central Connecticut Dermatology in Cromwell. “Have it on your radar. With all of the worldwide travel patterns, I expect that you will see this in the United States at some point in the not-too-distant future.”
Also in 2019, promising data on the safety and effectiveness of the recombinant herpes zoster vaccine in immunocompromised patients became available for the first time. A randomized clinical trial published in JAMA of 1,846 patients who were immunosuppressed after autologous hematopoietic stem cell transplantation and received two doses of a recombinant zoster vaccine found that the patients had a reduced incidence of herpes zoster after a median follow-up of 21 months (JAMA. 2019 Jul 9;322[2]:123-33). The study found that the recombinant vaccine was both safe and effective in these immunocompromised patients, “so we can easily generalize this to our dermatology population as well,” Dr. Finch said. In comparing the live attenuated and recombinant vaccines, he noted the recombinant vaccine requires two doses but appears to be slightly more effective. “The number needed to treat to prevent [one case] of zoster is about half as high as that for the live vaccine, and most importantly for us is, it’s safe in immunocompromised patients.”
2019 also saw a record high in the number of measles cases in the United States, the highest since 1993, Dr. Finch pointed out. Most cases were seen in the area in and around New York City, but the percentage of people across the United States who are vaccinated against measles is below the threshold for herd immunity to protect immunocompromised patients. Measles requires a population vaccination rate of 94%, and less than half of U.S. counties in 2014 and 2015 reached that vaccination rate.
“Furthermore, if we look at that over the last 20 years, comparing the domestic measles cases to imported measles cases, we are increasingly breeding these measles epidemics right here at home, whereas they used to be imported from throughout the world,” said Dr. Finch. Patients with measles can be treated with vitamin A, he added, referring to a Cochrane review showing that 200,000 units of vitamin A given daily for 2 days decreased the mortality rate of measles by about 80%. Measles is on the Centers for Disease Control and Prevention’s list of reportable diseases, so should be reported to local health authorities, and will be followed up with confirmatory testing.
In 2019, a study examining herd protection of oral human papillomavirus infection in men and women compared the prevalence of oral HPV infection based on the 4 HPV types present in the quadrivalent HPV vaccine with 33 nonvaccine types from 2009 to 2016. There was no change in the prevalence of nonvaccine type oral HPV infections among men who were unvaccinated, but the prevalence of oral HPV infections because of the four strains in the quadrivalent HPV vaccine declined from 2.7% in 2009-2010 to 1.6% in 2015-2016 (JAMA. 2019 Sep 10;322[10]:977-9). Among unvaccinated women, the prevalence of nonvaccine- and vaccine-type oral HPV infections did not change between the two time periods.
“Notably, this only occurred in men,” Dr. Finch said. Herd immunity is being achieved in men “because we’re vaccinating all women, [but] we’re not seeing that herd immunity in women. Which begs the question: Why are we still vaccinating only half of our population?”
One study published in 2019 (Br J Dermatol. 2019 Nov;181[5]:1093-5) described a patient with CARD9 mutations, which predispose individuals to deep invasive infections – a disseminated Microsporum infection in this case, Dr. Finch said. “You shouldn’t see that,” he added, noting that these mutations are known to predispose individuals to severe Trichophyton infections and familial candidiasis.
“What I think is interesting about this is that, as we look forward to 2020, we’re going to increasingly see studies like this that are identifying specific mutations in our community that underlie a lot of these weird infections,” he added. “I wouldn’t be surprised if within the span of our careers, we find that a lot of those severe treatment-refractory reports that so commonly plague your everyday clinic have some underlying, specific immunity.”
Dr. Finch reported no relevant conflicts of interest.
ORLANDO – – leading into 2020, Justin Finch, MD, said at the ODAC Dermatology, Aesthetic, & Surgical Conference.
While group A streptococcus has declined over the past century, there has been “an unprecedented” resurgence in severe, invasive group A streptococcal infections and severe epidemics of scarlet fever worldwide, including in industrialized regions like the United Kingdom. Shedding some light on why this may be occurring, Dr. Finch referred to a recently published population-based molecular epidemiologic study identified a new dominant emm1UK lineage of Streptococcus pyogenes associated with such cases in England (Lancet Infect Dis. 2019 Nov;19(11):1209-18). This new lineage of S. pyogenes was genotypically distinct from other emm1 isolates and had greatly increased expression of the streptococcal pyrogenic exotoxin A, one of the exotoxins responsible for the clinical features of scarlet fever.
“We have not, to my knowledge, seen the strain yet in the United States,” said Dr. Finch, of Central Connecticut Dermatology in Cromwell. “Have it on your radar. With all of the worldwide travel patterns, I expect that you will see this in the United States at some point in the not-too-distant future.”
Also in 2019, promising data on the safety and effectiveness of the recombinant herpes zoster vaccine in immunocompromised patients became available for the first time. A randomized clinical trial published in JAMA of 1,846 patients who were immunosuppressed after autologous hematopoietic stem cell transplantation and received two doses of a recombinant zoster vaccine found that the patients had a reduced incidence of herpes zoster after a median follow-up of 21 months (JAMA. 2019 Jul 9;322[2]:123-33). The study found that the recombinant vaccine was both safe and effective in these immunocompromised patients, “so we can easily generalize this to our dermatology population as well,” Dr. Finch said. In comparing the live attenuated and recombinant vaccines, he noted the recombinant vaccine requires two doses but appears to be slightly more effective. “The number needed to treat to prevent [one case] of zoster is about half as high as that for the live vaccine, and most importantly for us is, it’s safe in immunocompromised patients.”
2019 also saw a record high in the number of measles cases in the United States, the highest since 1993, Dr. Finch pointed out. Most cases were seen in the area in and around New York City, but the percentage of people across the United States who are vaccinated against measles is below the threshold for herd immunity to protect immunocompromised patients. Measles requires a population vaccination rate of 94%, and less than half of U.S. counties in 2014 and 2015 reached that vaccination rate.
“Furthermore, if we look at that over the last 20 years, comparing the domestic measles cases to imported measles cases, we are increasingly breeding these measles epidemics right here at home, whereas they used to be imported from throughout the world,” said Dr. Finch. Patients with measles can be treated with vitamin A, he added, referring to a Cochrane review showing that 200,000 units of vitamin A given daily for 2 days decreased the mortality rate of measles by about 80%. Measles is on the Centers for Disease Control and Prevention’s list of reportable diseases, so should be reported to local health authorities, and will be followed up with confirmatory testing.
In 2019, a study examining herd protection of oral human papillomavirus infection in men and women compared the prevalence of oral HPV infection based on the 4 HPV types present in the quadrivalent HPV vaccine with 33 nonvaccine types from 2009 to 2016. There was no change in the prevalence of nonvaccine type oral HPV infections among men who were unvaccinated, but the prevalence of oral HPV infections because of the four strains in the quadrivalent HPV vaccine declined from 2.7% in 2009-2010 to 1.6% in 2015-2016 (JAMA. 2019 Sep 10;322[10]:977-9). Among unvaccinated women, the prevalence of nonvaccine- and vaccine-type oral HPV infections did not change between the two time periods.
“Notably, this only occurred in men,” Dr. Finch said. Herd immunity is being achieved in men “because we’re vaccinating all women, [but] we’re not seeing that herd immunity in women. Which begs the question: Why are we still vaccinating only half of our population?”
One study published in 2019 (Br J Dermatol. 2019 Nov;181[5]:1093-5) described a patient with CARD9 mutations, which predispose individuals to deep invasive infections – a disseminated Microsporum infection in this case, Dr. Finch said. “You shouldn’t see that,” he added, noting that these mutations are known to predispose individuals to severe Trichophyton infections and familial candidiasis.
“What I think is interesting about this is that, as we look forward to 2020, we’re going to increasingly see studies like this that are identifying specific mutations in our community that underlie a lot of these weird infections,” he added. “I wouldn’t be surprised if within the span of our careers, we find that a lot of those severe treatment-refractory reports that so commonly plague your everyday clinic have some underlying, specific immunity.”
Dr. Finch reported no relevant conflicts of interest.
REPORTING FROM ODAC 2020
FDA approves novel pandemic influenza vaccine
The Food and Drug Administration has approved the first and only adjuvanted, cell-based pandemic vaccine to provide active immunization against the influenza A virus H5N1 strain.
Influenza A (H5N1) monovalent vaccine, adjuvanted (Audenz, Seqirus) is for use in individuals aged 6 months and older. It’s designed to be rapidly deployed to help protect the U.S. population and can be stockpiled for first responders in the event of a pandemic.
The vaccine and formulated prefilled syringes used in the vaccine are produced in a state-of-the-art production facility built and supported through a multiyear public-private partnership between Seqirus and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health & Human Services.
“Pandemic influenza viruses can be deadly and spread rapidly, making production of safe, effective vaccines essential in saving lives,” BARDA Director Rick Bright, PhD, said in a company news release.
“With this licensure – the latest FDA-approved vaccine to prevent H5N1 influenza — we celebrate a decade-long partnership to achieve health security goals set by the National Strategy for Pandemic Influenza and the 2019 Executive Order to speed the availability of influenza vaccine. Ultimately, this latest licensure means we can protect more people in an influenza pandemic,” said Bright.
“The approval of Audenz represents a key advance in influenza prevention and pandemic preparedness, combining leading-edge, cell-based manufacturing and adjuvant technologies,” Russell Basser, MD, chief scientist and senior vice president of research and development at Seqirus, said in the news release. “This pandemic influenza vaccine exemplifies our commitment to developing innovative technologies that can help provide rapid response during a pandemic emergency.”
Audenz had FDA fast track designation, a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
This article first appeared on Medscape.com.
The Food and Drug Administration has approved the first and only adjuvanted, cell-based pandemic vaccine to provide active immunization against the influenza A virus H5N1 strain.
Influenza A (H5N1) monovalent vaccine, adjuvanted (Audenz, Seqirus) is for use in individuals aged 6 months and older. It’s designed to be rapidly deployed to help protect the U.S. population and can be stockpiled for first responders in the event of a pandemic.
The vaccine and formulated prefilled syringes used in the vaccine are produced in a state-of-the-art production facility built and supported through a multiyear public-private partnership between Seqirus and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health & Human Services.
“Pandemic influenza viruses can be deadly and spread rapidly, making production of safe, effective vaccines essential in saving lives,” BARDA Director Rick Bright, PhD, said in a company news release.
“With this licensure – the latest FDA-approved vaccine to prevent H5N1 influenza — we celebrate a decade-long partnership to achieve health security goals set by the National Strategy for Pandemic Influenza and the 2019 Executive Order to speed the availability of influenza vaccine. Ultimately, this latest licensure means we can protect more people in an influenza pandemic,” said Bright.
“The approval of Audenz represents a key advance in influenza prevention and pandemic preparedness, combining leading-edge, cell-based manufacturing and adjuvant technologies,” Russell Basser, MD, chief scientist and senior vice president of research and development at Seqirus, said in the news release. “This pandemic influenza vaccine exemplifies our commitment to developing innovative technologies that can help provide rapid response during a pandemic emergency.”
Audenz had FDA fast track designation, a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
This article first appeared on Medscape.com.
The Food and Drug Administration has approved the first and only adjuvanted, cell-based pandemic vaccine to provide active immunization against the influenza A virus H5N1 strain.
Influenza A (H5N1) monovalent vaccine, adjuvanted (Audenz, Seqirus) is for use in individuals aged 6 months and older. It’s designed to be rapidly deployed to help protect the U.S. population and can be stockpiled for first responders in the event of a pandemic.
The vaccine and formulated prefilled syringes used in the vaccine are produced in a state-of-the-art production facility built and supported through a multiyear public-private partnership between Seqirus and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health & Human Services.
“Pandemic influenza viruses can be deadly and spread rapidly, making production of safe, effective vaccines essential in saving lives,” BARDA Director Rick Bright, PhD, said in a company news release.
“With this licensure – the latest FDA-approved vaccine to prevent H5N1 influenza — we celebrate a decade-long partnership to achieve health security goals set by the National Strategy for Pandemic Influenza and the 2019 Executive Order to speed the availability of influenza vaccine. Ultimately, this latest licensure means we can protect more people in an influenza pandemic,” said Bright.
“The approval of Audenz represents a key advance in influenza prevention and pandemic preparedness, combining leading-edge, cell-based manufacturing and adjuvant technologies,” Russell Basser, MD, chief scientist and senior vice president of research and development at Seqirus, said in the news release. “This pandemic influenza vaccine exemplifies our commitment to developing innovative technologies that can help provide rapid response during a pandemic emergency.”
Audenz had FDA fast track designation, a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
This article first appeared on Medscape.com.