The U.S. may be getting its first adjuvanted flu vaccine.
On Tuesday, an FDA panel recommended accelerated approval of Novartis' ($NVS) Fluad--now owned by CSL's flu vaccine subsidiary--in individuals 65 and older. Though the vaccine has been approved in Europe since 1997 and is used in dozens of countries, it would be the first boosted flu vaccine available to the U.S. public if the FDA takes the recommendation.
The FDA isn't required to follow the guidance in its ruling, but the agency typically follows panel votes.
Adjuvants--which are added to vaccines to increase the body's immune response--have had a troubled past in the U.S. as officials have shown concern about public suspicion of ingredients such as the preservative thimerosal. However, vaccine companies continue to look for ways to more effectively immunize seniors, who have weaker immune systems than those in other age groups.
Those 65 and older can be more susceptible to flu complications due to their reduced responses to vaccines, accounting for more than half of flu-related hospitalizations and about 90% of flu-associated deaths, CDC figures show.
The panel found Fluad, containing the proprietary MF59 adjuvant, to be effective for individuals 65 and older by an 11-to-1 vote, with 1 abstention, and safe for the age group by a 10-to-2 vote, with 1 abstention. The only other adjuvanted flu vaccine in the U.S., containing AS03, is in stockpiling and is not available for public use.
"While it's important to vaccinate people against the flu throughout their lives, we are proud to have developed an alternative solution to help meet a major public health need of adults aged 65 and older, one of the populations at greatest risk for seasonal influenza," Brent MacGregor, global head of CSL subsidiary NVS Influenza Vaccines, said in a statement.
Although it's been approved for nearly two decades in Europe, Fluad hasn't been devoid of controversy there. Late last year, Italian regulators temporarily banned Fluad after 19 deaths were reported after vaccination. However, officials shortly later said that tests showed the vaccine was safe.
With CSL's purchase of Novartis' flu vaccines business early last month, the company becomes the world's second largest flu vaccine supplier behind Sanofi ($SNY).
Postmarketing studies would be required if Fluad is granted accelerated approval.
- here's the release
- get more from the Center for Infectious Disease Research and Policy
- and a story from Medscape (reg. req.)