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US would seek global approach to updating Covid vaccines, official says - STAT
Jan 18, 2022 1 min, 36 secs

If the Food and Drug Administration decides to update Covid-19 vaccines to take better aim at Omicron or other variants, it is unlikely to go it alone.

Instead, a senior FDA official told STAT, the agency expects to take part in an internationally coordinated program aimed at deciding if, when, and how to update Covid-19 vaccines.

“We can’t have our manufacturers going willy-nilly [saying], ‘Oh well, the EMA decided they wanted this composition, but FDA wanted that composition,’” the official said, referring to the European Medicines Agency.

The approach will likely be modeled on — though perhaps not identical to — a program used for decades to decide which strains should be included in influenza vaccines, the official said, speaking on condition of anonymity.

Last week, regulatory agencies from around the globe met to discuss, among other things, what would be required to update the vaccines.

“I think we very much are going to try to align with our large regulatory colleagues like the EMA,’’ the official said.

The Omicron variant’s capacity to partially evade the immune protections elicited by Covid vaccines is making the planning for a process to update vaccines more critical

Several of the manufacturers are testing Omicron-based vaccines and the partnership of Pfizer and BioNTech has already indicated it expects to have data by early March

If future variants are markedly different, the cross-protection generated by an Omicron-based vaccine might not be as robust as the protection generated by the original vaccines or those targeted at, for example, the Delta variant

The official said that in addition to the need to harmonize vaccine updates internationally, there’s a domestic imperative at play

“We do not particularly relish the idea of each manufacturer having their own flavor of secret sauce,” the official said

The goal with Covid vaccines is to have them work in the same manner, if it becomes clear regular or annual boosting will be needed, the FDA has said

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