U.S. yellow fever vaccine stocks could be depleted within months

 

Supply of the only U.S.-licensed yellow fever vaccine will be depleted by mid-2017 because of manufacturing issues, according to the Centers for Disease Control and Prevention.

Sanofi Pasteur, the manufacturer of the YF-VAX vaccine, notified the CDC and the Food and Drug Administration in 2016 there could be a shortage this year after the manufacturing complications during a factory switch over led to the loss of a large amount of vaccine supply, according to an article published online in the Morbidity and Mortality Weekly Report.

The shortage is expected to affect government workers and military personnel as well as private travelers, 8 million of whom traveled to at least one of 42 countries with endemic yellow fever virus transmission in 2015 (MMWR. 2017 Apr 28. doi: 10.15585/mmwr.mm6617e2).

The CDC, Sanofi Pasteur, and the FDA are working to supplement the shortage. The manufacturer submitted an expanded investigational new drug (eIND) application to the FDA in September 2016 for marketing permission for Stamaril, an alternative vaccine manufactured by Sanofi Pasteur France and used in around 70 countries.

The application included planning for strategic distribution sites, which the CDC is determining using a tiered system based on volume of doses ordered in 2016.

As of April 2017, 250 civilian sites have been invited to participate in the eIND program, significantly less than the 4,000 currently distributing YF-VAX.

The CDC will “monitor for critical gaps in vaccine access and collaborate to address any issues, including considering the possibility of recruiting additional clinics to participate as necessary,” according to a statement.

Updates on the shortage will be available on the CDC travel health website.

[email protected]

On Twitter @eaztweets

 

Supply of the only U.S.-licensed yellow fever vaccine will be depleted by mid-2017 because of manufacturing issues, according to the Centers for Disease Control and Prevention.

Sanofi Pasteur, the manufacturer of the YF-VAX vaccine, notified the CDC and the Food and Drug Administration in 2016 there could be a shortage this year after the manufacturing complications during a factory switch over led to the loss of a large amount of vaccine supply, according to an article published online in the Morbidity and Mortality Weekly Report.

The shortage is expected to affect government workers and military personnel as well as private travelers, 8 million of whom traveled to at least one of 42 countries with endemic yellow fever virus transmission in 2015 (MMWR. 2017 Apr 28. doi: 10.15585/mmwr.mm6617e2).

The CDC, Sanofi Pasteur, and the FDA are working to supplement the shortage. The manufacturer submitted an expanded investigational new drug (eIND) application to the FDA in September 2016 for marketing permission for Stamaril, an alternative vaccine manufactured by Sanofi Pasteur France and used in around 70 countries.

The application included planning for strategic distribution sites, which the CDC is determining using a tiered system based on volume of doses ordered in 2016.

As of April 2017, 250 civilian sites have been invited to participate in the eIND program, significantly less than the 4,000 currently distributing YF-VAX.

The CDC will “monitor for critical gaps in vaccine access and collaborate to address any issues, including considering the possibility of recruiting additional clinics to participate as necessary,” according to a statement.

Updates on the shortage will be available on the CDC travel health website.

[email protected]

On Twitter @eaztweets

 

Supply of the only U.S.-licensed yellow fever vaccine will be depleted by mid-2017 because of manufacturing issues, according to the Centers for Disease Control and Prevention.

Sanofi Pasteur, the manufacturer of the YF-VAX vaccine, notified the CDC and the Food and Drug Administration in 2016 there could be a shortage this year after the manufacturing complications during a factory switch over led to the loss of a large amount of vaccine supply, according to an article published online in the Morbidity and Mortality Weekly Report.

The shortage is expected to affect government workers and military personnel as well as private travelers, 8 million of whom traveled to at least one of 42 countries with endemic yellow fever virus transmission in 2015 (MMWR. 2017 Apr 28. doi: 10.15585/mmwr.mm6617e2).

The CDC, Sanofi Pasteur, and the FDA are working to supplement the shortage. The manufacturer submitted an expanded investigational new drug (eIND) application to the FDA in September 2016 for marketing permission for Stamaril, an alternative vaccine manufactured by Sanofi Pasteur France and used in around 70 countries.

The application included planning for strategic distribution sites, which the CDC is determining using a tiered system based on volume of doses ordered in 2016.

As of April 2017, 250 civilian sites have been invited to participate in the eIND program, significantly less than the 4,000 currently distributing YF-VAX.

The CDC will “monitor for critical gaps in vaccine access and collaborate to address any issues, including considering the possibility of recruiting additional clinics to participate as necessary,” according to a statement.

Updates on the shortage will be available on the CDC travel health website.

[email protected]

On Twitter @eaztweets