The ongoing global yellow fever vaccine shortage has hit the U.S., as Sanofi Pasteur’s YF-VAX, the only FDA-approved prophylactic shot for the disease, will soon run out, according to the CDC.
To cope with the situation, Sanofi Pasteur is providing another version of the vaccine through an expanded access to investigational new drug (eIND) program, which the FDA accepted in October 2016. The alternative, called Stamaril, has shown similar safety and efficacy as YF-VAX, and has been licensed in about 70 countries since 1986.
After consulting with the CDC, Sanofi Pasteur compiled a list of about 250 U.S. clinic sites to participate in the program for travelers. Sanofi will also be responsible for coordinating site recruitment and training. Although they cover all 50 states, the District of Columbia and the three U.S. territories, the number is still a significant reduction from the usual 4,000 clinics that currently offer yellow fever vaccines.
The U.S. shortage first cropped up in November 2015, when the French vaccinemaker lost a large number of doses due to manufacturing problems at its Swiftwater, Pennsylvania, campus while transferring production to a new facility.
Although Sanofi Pasteur managed to provide some additional doses and started to impose ordering restrictions in late 2016, complete depletion will still hit this summer, the CDC reports. The agency previously ruled out a proposal calling for smaller doses, citing a lack of efficacy data.
In the U.S., the limited-access situation might not be alleviated until the new Sanofi facility opens in 2018. Until then, the CDC recommends that people planning to travel to areas at risk in South America and Africa either search for an alternative shot or postpone their travel.
Around the world, the global yellow fever vaccine shortage has been ongoing for some time now—and will persist through at least this year as predicted by UNICEF. Besides Sanofi Pasteur and Brazilian research organization Fiocruz, the Institut Pasteur Foundation in Dakar and a state-owned Russian manufacturer make yellow fever vaccines, but limited production capacity, plus emergency vaccination requirements from recent outbreaks, have combined to create the run on supplies.
In Brazil, local authorities have reported (PDF) 681 confirmed yellow fever cases between December 2016 and April 20. Responding to the emergency, Brazil’s Ministry of Health recently ordered 11.5 million yellow fever doses from a unit of Fiocruz for its national stockpile.
Last April, scientists proposed cutting the vaccine dosage by four-fifths, from 0.5 ml to 0.1 ml, as a short-term emergency measure to fight the global shortage. World Health Organization officials have been considering the strategy but are still shy of a final decision.