the US Food and Drug Administration The FDA is expected to approve new Covid-19 booster vaccines for newer strains from Omicron this week, making them accessible to people in the country before human testing ends, media reported.
The vaccines have been modified to target the latest Omicron variant, but the US FDA will not have finished testing them in humans, the Daily Mail reported The Wall Street Journal as saying.
The report noted that the FDA is instead relying on information from other sources, such as mouse studies and data from previous immunizations.
“Real-world evidence from current mRNA Covid-19 vaccines, which have been administered to millions of people, shows us that the vaccines are safe,” FDA Commissioner Robert Califf said in a tweet last week. .
The official also wrote that the FDA will rely on the totality of available evidence to make a decision.
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 the BA.4/5 bivalent vaccines.
The data from the clinical trials, which will be used for vaccine approval, is similar to the approach the FDA uses regarding flu vaccines, which are updated annually to keep up with mutant strains, the report said. .
But some vaccine experts aren’t fans of the approach and believe it would be better to wait, rather than use “mouse data,” he added.
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