The US Food and Drug Administration (FDA) is expected to approve new COVID-19 booster vaccine shots for the newer Omicron variants this week, making them accessible to people in the United States before any of the human testing is completed.
The updated COVID-19 vaccines have been modified to target and focus on the most recent Omicron variant, but the US FDA will not have finished the testing on human beings. According to a report, the US FDA is relying on information and data from other sources, like mice study, and data from past immunisation.
Robert Califf, FDA Commissioner, said the real-world evidence from the current mRNA COVID-19 vaccines that have been administered to millions of individuals, shows that the COVID-19 vaccines are safe.
He also said that the US FDA will rely on the totality of the available evidence in making a decision. This also includes, clinical data from the other bivalent mRNA COVID-19 vaccine boosters, and the RWE from the current COVID-19 vaccines administered to millions of people, and the non-clinical data for the bivalent vaccines.
Some vaccine experts believe that it will be better to wait, rather than go with the data from the mouse test.
