May 3, 2017

CDC: US could run out of yellow fever vaccine by mid-2017

Daily Briefing

The United States' supply of a vaccine for yellow fever could run out this summer because of a "manufacturing complication," according to a CDC Morbidity and Mortality Weekly Report published Friday.

Yellow fever has been eradicated in the United States, but CDC recommends the vaccines for U.S. residents traveling to countries with "endemic or epidemic yellow fever virus transmission."

Shortage details

CDC said the United States' supply of the vaccine, called YF-VAX, could be depleted by as early as June.

The agency attributed the anticipated shortage to "a manufacturing complication" at Sanofi Pasteur's Swiftwater, Pennsylvania, plant.  According to "Shots," Sanofi Pasteur is the only pharmaceutical company licensed to manufacture the U.S.-approved vaccine.

Sanofi said broken equipment at the facility caused the company to lose a large number of doses of the vaccine. The company expects to open a new facility and resume production of the vaccine by mid-2018, according to the Washington Post's "To Your Health."

Issues with the world's supply of yellow fever vaccines have concerned health officials for years, but recent outbreaks of the virus in places such as Angola, Brazil, and the Democratic Republic of Congo have heightened fears of vaccine shortages.

CDC to collaborate with FDA to import yellow fever vaccines from France

To address the anticipated shortage in the United States, CDC is collaborating with FDA and Sanofi Pasteur to expand access to an alternative yellow fever vaccine, called Stamaril, which will be imported from France. Stamaril, which has a similar safety profile and effectiveness as YF-VAX, is not currently available in the United States, but is licensed in more than 70 other countries.

According to the "To Your Health," Stamaril will be available at about 250 of the 4,000 U.S. clinics that typically administer Sanofi's vaccine. It will be distributed under FDA's expanded access provision, which allows the agency to dispense vaccines and treatments outside of clinical studies in emergency situations.

CDC has posted a list of clinical sites where the yellow fever vaccine is currently available.

Comments

Marty Cetron, who oversees CDC's division of global migration and quarantine, said the plan is a "safety net" intended to ensure that there is a continuous supply of yellow fever vaccines in the country.

However, he acknowledged that there would be several logistical challenges, including a reduced number of clinics offering the vaccine due to monitoring and data gathering requirements under FDA's expanded access program. He urged individuals who need to get the vaccine to "plan ahead," noting that it might take them longer to access the immunization.

CDC spokesperson Tom Skinner added that travelers who need the vaccine but "can't get it" should "postpone" their trips.

Sanofi said it "recognizes the challenge this supply disruption will cause for customers and for patients in need of yellow fever vaccine," adding that it would make "every effort to see that yellow fever vaccination continues in the [United States] during this YF-VAX vaccine supply disruption" (Doucleff, "Shots," NPR, 4/28; Stobbe, AP/USA Today, 4/28; Eunjung Cha, "To Your Health," Washington Post, 4/28; Gershman et al., Morbidity and Mortality Weekly Report, 4/28).

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