Supply of yellow fever vaccines dwindling
CDC plans to bring in French version to restock U.S. clinics
U.S. health officials warned of a new complication in the fight to contain mosquito-borne viruses spreading around the world: The country’s supply of yellow fever vaccine is dwindling and will likely be completely gone by this summer — with no way to make more because of a manufacturing problem.
The shortage comes at a troubling time. Multiple outbreaks of yellow fever, which was eradicated in many countries by the 1920s, have popped up around the world in recent years in places such as Angola, the Democratic Republic of Congo and, most recently, Brazil.
The Centers for Disease Control and Prevention’s Marty Cetron said the CDC has been collaborating with the Food and Drug Administration and Sanofi Pasteur, which makes the vaccine, to address the shortage by expanding access to a different type of yellow fever vaccine that will be imported from France.
That vaccine, Stamaril, is considered investigational and is unlicensed in the United States but is registered in more than 70 other countries and is believed to have a comparable safety and efficacy profile to the one currently in use in the United States.
Stamaril is being made available outside the regular multiyear, multilayer review process required by the FDA for new vaccines through an “expanded access” provision, which allows for a wider distribution of a drug beyond a limited clinical trial in emergency situations. The provision has more typically been used to grant so-called compassionate use of unapproved drugs to severely ill patients when no alternative is available.
In an interview, Cetron, who oversees the CDC’s division of global migration and quarantine, called the plan a “safety net” that will assure a continuous supply of yellow fever vaccine in the United States.
However, he acknowledged it would not be without logistical challenges.
The main issue for consumers will be that the number of clinics offering the new yellow fever vaccine will be greatly reduced, from about 4,000 to 250, because of the increased complexity of monitoring and data gathering through the expanded access program, which is similar to a clinical trial.
“People who are accustomed to doing things at the last minute should know it may take longer to assure they can get to the right clinic. They should plan ahead,” Cetron said.
He also emphasized that yellow fever is a serious disease — among those who come down with a severe infection, 20 to 50 percent die — and that travelers should heed advice to get the vaccine when traveling to an area where the viral disease is present. Estimates of the number of people infected range from 84,000 to 174,000 annually. About 60,000 are believed to die globally each year from the disease, which is transmitted by the same mosquito as Zika.
“This is an important vaccine to get,” he said. “Don’t blow it off.”