Could flu shot supply fall short this year?
FDA’s sudden decision sparks concerns about vaccine production
The Food and Drug Administration’s (FDA) abrupt decision to cancel next month’s vaccine advisory committee meeting is raising concerns about whether the U.S. will have enough flu vaccine for the next season. The meeting, where experts recommend the strains for next season’s flu shot, was scheduled for March 13, with a final decision from the agency on the strain expected shortly after.
Drugmakers face tight deadline
Drugmakers already face a tight deadline each year to produce enough doses for distribution in the fall. The federal government typically places preorders for the vaccines in January and February, which appears to have been done as usual. However, manufacturers cannot start making the doses until the FDA selects the strains.
Manufacturers’ timeline
According to Litjen Tan, co-chair of the flu shot advocacy group the National Adult and Influenza Immunization Summit, shots are usually available by the end of July or early August. The advisory committee meeting plays a key role in the process, as the flu virus is constantly evolving, requiring updates to the vaccine to provide the best protection.
Concerns about strain selection
Tan said that depending on the vaccine technology used, manufacturers can wait until late March for input from the FDA on strain selection to produce enough doses for the fall. However, if the delay is any longer, it will put manufacturers in a huge bind.
Flu season’s severity adds to concerns
The cancelation of the meeting comes amid a particularly bad flu season this year, with as many as 910,000 hospitalizations so far, according to the Centers for Disease Control and Prevention (CDC). At least 86 children and 19,000 adults have died.
Uncertainty ahead
In a statement, Andrew Nixon, a senior spokesperson for the Department of Health and Human Services, which oversees the FDA, said the agency will “make public its recommendations to manufacturers in time for updated vaccines to be available for the 2025-2026 influenza season.” However, Nixon did not answer questions about why the meeting was canceled or whether the agency would seek input from its outside advisory committee.
Alternative options
Dr. Ofer Levy, director of the precision vaccines program at Boston Children’s Hospital, who has advised the FDA on vaccines, said that if the agency decides not to seek input from its committee, it won’t be entirely in the dark. The World Health Organization (WHO) is convening a meeting on Friday to decide which strains should be included in next season’s flu vaccines for the Northern Hemisphere.
Conclusion
The cancellation of the FDA’s advisory committee meeting has raised concerns about whether the U.S. will have enough flu vaccine for the next season. While drugmakers are preparing for next year’s flu season, the uncertainty surrounding the strain selection process has left many wondering if they will be able to produce enough doses in time.
FAQs
* What is the purpose of the FDA’s advisory committee meeting?
The meeting is where experts recommend the strains for next season’s flu shot.
* Why was the meeting canceled?
The reason for the cancellation is unclear, but it has raised concerns about the strain selection process.
* Can drugmakers produce enough doses without the meeting?
Yes, but it will be a tight deadline, and any further delay could put manufacturers in a huge bind.
* What is the current state of the flu season?
As many as 910,000 hospitalizations have been reported, with at least 86 children and 19,000 adults having died.
* Will the WHO’s meeting have an impact on the FDA’s decision?
Yes, the WHO’s meeting will guide the FDA’s strain selection, but it is unclear if drugmakers can begin producing doses based on the WHO’s recommendation or if they must wait for the FDA’s guidance.
