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. The approach would ensure decisions are not left solely to individual vaccine manufacturers.
“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. “So we are very much of the mind that we would like to be part of a more global process in helping to come to what vaccine composition there should be now.”
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.
The World Health Organization has been working to organize such a process for Covid-19 vaccines for some time. Last week, regulatory agencies from around the globe met to discuss, among other things, what would be required to update the vaccines. ...
