Ahead of an advisory committee meeting this week, the FDA said that similar to flu vaccinations, the annual administration of updated COVID-19 vaccines will be appropriate against a fast-changing virus.
“…experience from influenza vaccine strain composition changes for U.S. vaccines suggests that implementation of an annual vaccine composition evaluation and recommendation would likely be practical for COVID-19 vaccines,” the regulator said.
The FDA made these comments in briefing documents released ahead of a Vaccines and Related Biological Products Advisory Committee (VBRAC) Meeting scheduled for Jan. 26.
The FDA has so far greenlighted COVID-19 vaccines developed by Pfizer (NYSE:PFE)/BioNTech (NASDAQ:BNTX), Moderna (NASDAQ:MRNA), Johnson & Johnson (JNJ), and Novavax (NVAX).
In September, the U.S. rolled out mRNA-based COVID shots developed by Pfizer (PFE)/BioNTech (BNTX) and Moderna (MRNA) as boosters targeting Omicron BA.4 and BA.5 subvariants.
However, recent studies have indicated that updated bivalent shots have performed poorly against newly dominant COVID variants such as BQ.1.1 and XBB.
“As such, an annual frequency may provide a reasonable and practical starting point to implement COVID-19 vaccine composition evaluation and recommendations in the U.S,” the FDA said.
The regulator plans to conduct such an annual assessment and begin reviewing data in spring each year ahead of an updated vaccine rollout by September. The regulator does not rule out emergency VBRAC meetings if more virulent and immune-evasive COVID-19 variants circulate.
Pfizer (PFE)/ BioNTech (BNTX) and Moderna (MRNA) have already announced plans to hike COVID vaccine prices as vaccine distribution transitions to a commercial market from government-led procurements.