FDA Abandons Gathering of Independent Advisers and Announces Recommendations for 2025-2026 Flu Vaccine
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Hopping on the Flu Shot Bandwagon - Solo Act or Ensemble Performance?
Last Thursday, the US Food and Drug Administration (FDA) took center stage, unveiling its suggestions for the composition of this year's flu shots. But, surprisingly, without guidance from their trusted independent vaccine advisors.
Initially, the FDA's Vaccines and Related Biological Products Advisory Committee were due to convene on Thursday to deliberate on the flu shot composition. However, that meeting was surprisingly scrapped towards the end of February without an explanation.
In its place, a group of experts from within the FDA, the US Centers for Disease Control and Prevention (CDC), and the US Department of Defense came together to review data from the US and worldwide on flu viruses that are currently in circulation.
The FDA is advocating for flu vaccines in the upcoming season to be trivalent, offering protection against two strains of influenza A and one of influenza B. The FDA anticipates an ample and varied supply of approved trivalent seasonal influenza vaccines for this year.
While there are various methods to manufacture flu vaccines, the most common is cultivating the selected candidate viruses in chickens, a laborious process that can take months to complete. This careful selection of strains ensures that manufacturers can distribute the shots to medical facilities on schedule.
For a vaccine to be marketed in the US, it must contain strains officially selected by the FDA, a decision typically made post meetings of the World Health Organization's Global Influenza Surveillance and Response System. This network comprises seven collaborating centers and four essential regulatory labs based in countries like the US, UK, Japan, China, Russia, and Australia. Both the CDC and the FDA are part of this global network.
Twice a year, these experts gather – in the fall and spring – to determine the strains for countries in both the Southern and Northern Hemispheres. The World Health Organization's vaccine recommendations for the upcoming season generally align with those of the FDA.
Traditionally, the 17-member FDA vaccine committee would meet next, openly discussing the recommendation and earning their endorsement. Afterward, the agency would make its final decision.
The abrupt cancellation of the committee meeting had sparked concerns about the accessibility and timing of flu shots for this fall. "I'm relieved that they've announced the influenza recommendation in a timely manner," Dr. Paul Offit, a member of the independent advisory committee and director of the Vaccine Education Center at the Philadelphia Children's Hospital, expressed on Thursday.
The 2023-24 flu season - the most severe in over a decade in the US - is estimated to have reached its peak in early February. As of early March, the CDC estimated that there had been at least 40 million illnesses, 520,000 hospitalizations, and 22,000 deaths due to flu this season.
CNN's Meg Tirrell contributed to this report.
- The FDA anticipates an ample and varied supply of approved trivalent seasonal influenza vaccines for the year 2023, offering protection against two strains of influenza A and one of influenza B.
- In the upcoming season, pharmacies are expected to stock trivalent flu vaccines, as the FDA advocates for these vaccines to combat influenza.
- By 2025, it is anticipated that there will be a range of approved trivalent seasonal influenza vaccines available at pharmacies, providing protection against the influenza viruses currently circulating worldwide.
