FDA authorizes updated COVID boosters

WASHINGTON, D.C. (CNN) – One hurdle is now cleared for new COVID-19 vaccines. On Wednesday, the US Food and Drug Administration gave a green light to updated boosters aimed at the most dominant variants. But, a top us health official is also responding to criticism that the government is moving too quickly on the boosters.

In the US, BA.5 continues to be the dominant variant, last week causing nearly nine out of ten new COVID infections, according to CDC estimates.

CDC Director Dr. Rochelle Walensky said, “I would really love to be ahead of this variant this season.”

That’s what the updated COVID-19 boosters are aimed at doing. It’s a “bivalent” vaccine, which means it contains mRNA encoding from the original coronavirus spike protein together with mRNA encoding the spike protein from the Omicron BA-4 and BA-5 variants.

“As we have updated these boosters for the fall, the data that we are looking at is related to very, very small changes in the mRNA sequence and really shouldn’t impact safety at all,” Dr. Walensky said.

Both Moderna and Pfizer have been given initial emergency use authorization from the FDA for their updated boosters, but there is some criticism that the US Government is moving too quickly and without enough human data.

Dr. Walensky said, “There’s always a question here of being too slow or too fast, and I think one of the challenges is if we wait for those data in human data — not just mice data, in human data — we will be using what I would be using, what I would consider to be a very outdated vaccine.”

Dr. Walensky said the strategy now is to tailor vaccines that would have the greatest effect, ideally one that would have less waning over time by targeting the variants that are dominant now.

It’s now up to an advisory committee with the Centers for Disease Control and Prevention to recommend the new boosters. The agency’s director would then need to accept that recommendation before the new vaccines would be available. That vote is expected to happen Thursday.

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