
Coronavirus vaccines should be updated to address omicron BA.4/5 coronavirus variants that are rapidly becoming the dominant strains around the world, including in the U.S. This was the conclusion reached by the Food and Drug Administration's (FDA) panel of independent experts on the Vaccines and Related Biological Products Advisory Committee. The modified vaccines would add an omicron BA.4/5 spike protein component to the current vaccine composition to create a two-component (bivalent) booster vaccine that would be available around October.
Instead of requiring manufacturers to engage in long and drawn-out clinical trials before approving the booster shots, the FDA is taking advantage of the drugmakers' ability to rapidly modify the new mRNA vaccines as the virus evolves. This approval process is similar to the way through which annual flu shots are updated.