The US Food and Drug Administration (FDA) may this week approve a COVID-19 booster dose for the new Omicron strain. This information has come out through the media. The Daily Mail, citing The Wall Street Journal, reported that the vaccines have been modified to target the Omicron variant but the US FDA has yet to end their testing on humans.
The report noted that, “the FDA has instead relied on information from other sources, such as mice studies and data from previous vaccinations.”
“The current mRNA COVID-19 vaccines that have been administered to millions of people show us they are safe,” FDA Commissioner Robert M. Califf said in a tweet last week.
The official Also Wrote That the FDA Would Decide on the Totality of the Evidence Available
This includes clinical trial data from other bivalent mRNA COVID-19 boosters, RWEs from current COVID-19 vaccines administered to millions of people, and non-clinical data for bivalent BA 4/5 vaccines.
The report said that the clinical trial data, which will be used for the clearance of vaccines, is similar to the approach used by the FDA with regard to flu shots, which are updated annually to keep up with mutating strains. Is.
But some vaccine experts are not liking it. He believes that it would be better to wait rather than go with ‘mouse data’.
