The Food and Drug Administration (FDA) on Thursday recommended COVID-19 vaccine manufacturers change the design of their booster shots beginning this fall to include components tailored to combat the currently dominant Omicron BA.4 and BA.5 subvariants of the coronavirus.
If authorized, the changes would mark the first major retooling of COVID-19 vaccines, but also could slow their rollout as the FDA has recommended a design somewhat different from what the companies had already tested and started producing.
The FDA will not require new studies testing the BA.4/BA.5 shots in humans to be completed for authorization, a top agency official told Reuters, similar to how annual changes to flu vaccines are handled….