Expecting the supply of the United States’ only licensed yellow fever vaccine to disappear in July, officials are distributing another brand to sites nationwide to ensure at-risk travelers can be protected.
CDC officials discussed the plan at a meeting of the agency’s Advisory Committee on Immunization Practices (ACIP) in Atlanta. It includes an effort by the CDC and other agencies to distribute Sanofi Pasteur’s yellow fever vaccine, Stamaril, which is not licensed in the U.S.
The measure was allowed when, in October 2016, the FDA approved an expanded-access investigational New Drug Application by Sanofi Pasteur. Currently, YF-VAX — also manufactured by Sanofi Pasteur — is the only vaccine licensed in the U.S., but production of that vaccine was hampered in the fall of 2016 when, according to the company, “manufacturing complications resulted in the loss of a large number of doses.” At that time, Sanofi had started to transition production to a new facility that officials say will begin operating in the middle of 2018.
As the supply of YF-VAX dwindled, CDC officials and others sought a way to safeguard those traveling to countries where yellow fever is endemic.
“Our focus has been to provide a continuous supply of yellow fever vaccine in the U.S. for travelers, government employees, military and other response groups,” David Greenberg, MD, associate vice president and regional medical head of Sanofi Pasteur, North America, said in a presentation at the ACIP meeting. “To that end, we have held stakeholder discussions for over a year with the CDC, FDA, Department of Defense and others to manage the remaining supply of YF-VAX and to import the alternative vaccine.”
The vaccine is important to anyone traveling to countries in which yellow fever is endemic — namely, tropical areas of Africa and Central and South America. Recent outbreaks include those reported in Angola, Uganda and the Democratic Republic of the Congo in 2016, and in Suriname and Brazil earlier this year.
Sanofi Pasteur began supplying Stamaril to U.S. clinics on May 23, Greenberg said, and the company is enrolling about 250 clinics across the country to distribute the vaccine under the expanded-access program.
As of June 15, Greenberg said, 245 clinical sites had expressed interest in administering the vaccine, and staff at 194 of them had completed training on using it. The clinics will use Stamaril until Sanofi Pasteur’s new YF-VAX facility is operating, he added.
A map showing the locations of clinics administering Stamaril can be found here.
Stamaril — a live, attenuated vaccine — is used in more than 100 countries, Greenberg said. It targets the 17D-204 yellow fever strain, the same one YF-VAX addresses. Greenberg added that Stamaril’s safety and efficacy are comparable to that of YF-VAX. – by Joe Green
WHO. Yellow fever fact sheet. http://www.who.int/mediacentre/factsheets/fs100/en/. Accessed June 23, 2017.
Disclosure: Greenberg is employed by Sanofi Pasteur.