FDA lights green COVID boosters targeting Omicron ahead of revaccination campaign

Aug 31 (Reuters) – The U.S. Food and Drug Administration on Wednesday authorized updated COVID-19 booster doses from Pfizer (PFE.N) / BioNTech (22UAy.DE) and Moderna targeting the predominant BA.4 and BA.5 Omicron sub variants The government is preparing for a massive vaccination campaign in the fall that could begin within days.

The new vaccines also include the original version of the virus that all previous COVID shots targeted.

The Food and Drug Administration (FDA) has authorized the shots for everyone 12 years of age or older who has had the initial vaccination series and has been at least two months off the previous booster vaccine, which is shorter than previously recommended periods.

Dr. Peter Marks, a senior FDA official who oversees vaccines, said he hopes the vaccines will restore the very good protection against symptomatic disease that the original vaccines did when they were released in late 2020 and early 2021.

“We don’t really know yet if we’ll reach the same level, but that’s the goal here,” Marks said.

The government began work on the rollout in the fall, which could begin shortly after the U.S. Centers for Disease Control and Prevention (CDC) external panel of experts meets on Thursday and agency Administrator Rochelle Walinsky makes a final recommendation.

The United States has taken more than 170 million doses of the two shots in an effort to stave off the worst effects of a potential surge in infections as schools gather and people spend more time indoors due to the cold weather.

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The FDA said Moderna’s recombinant vaccine is licensed for those age 18 and older, while the Pfizer/BioNTech vaccine will be available to those age 12 and older.

Pfizer said it has some doses ready to ship immediately and can deliver up to 15 million doses by September 9. Moderna said it expects its new doses to be available “in the coming days.”

Experts said updated vaccines will be important for the elderly and those with weakened immunity, but note that there is limited data to support the level of protection the government hopes.

“For people who are not infected and whose last dose was a year ago, yes, it will benefit them. How much, I can’t tell you,” said Dr. Gregory Poland, a Mayo Clinic vaccination expert. He said the new shots were unlikely to help those who had been injured recently.

This fall’s revaccination campaign is expected to target a much larger number of the former boosters the Food and Drug Administration authorized earlier this year. Officials said concerns about the prolonged COVID were one of the reasons younger, healthier Americans were getting the shot.

“If there is anything that will prevent transmission and COVID for a long time, it will be a specific vaccine variant of the variant that is currently in circulation,” said FDA Commissioner Robert Califf.

Different vaccines in other countries

About 50% of those over the age of 12 in the United States – about 107 million people – have received at least one booster dose of COVID-19 so far.

Some scientists have criticized the recommendation that would allow a new reinforcer just two months after the previous shot, saying that a longer gap would improve immune responses. FDA officials said the vast majority of Americans are more than two months away from the last shot.

Other countries including Canada and the United Kingdom have also requested updated Omicron vaccine boosters for fall campaigns, although some have purchased shots designed for the BA.1 Omicron variant that caused the record spike in COVID cases last winter.

The U.S. Food and Drug Administration in June asked vaccine makers to design snapshots that match the BA.4/BA.5 subvariants of the virus responsible for the latest surge in infections worldwide. Subfactor BA.5 accounts for more than 88% of infections in the United States.

Vaccine makers have not yet completed testing of novel BA.4/BA.5-based enhancers in humans. The FDA bases its decision on safety and efficacy data from the original shots as well as from clinical trials of reinforcers using the BA.1 Omicron variant.

Additional reporting by Mrinalika Roy in Bengaluru, Julie Steinhuisen in Chicago and Michael Erman in Maplewood New Jersey; Additional reporting by Ahmed Abul-Enein in Washington. Editing by Caroline Homer and Bill Bercrot

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