U.S. FDA green lights Omicron-targeted COVID boosters ahead of revaccination campaign

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Aug 31 (Reuters) – The U.S. Food and Drug Administration on Wednesday cleared Pfizer’s updated COVID-19 booster shots (PFE.N)/BioNTech (22UAy.DE) and Moderna that target the dominant BA.4 and BA.5 Omicron subvariants, as the government prepares for a massive fall vaccination campaign that could begin within days.

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

The FDA has cleared the shots for anyone age 12 and older who has had a primary vaccination series and is at least two months away from a previous booster shot, shorter than previously recommended intervals.

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Dr. Peter Marks, a senior FDA official overseeing vaccines, said he hoped the vaccines would restore the very good protection against symptomatic disease offered by the original vaccines when they were launched in late 2020 and early 2021.

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

The government has begun work on the fall rollout, which could begin shortly after Thursday’s meeting of the US Centers for Disease Control and Prevention (CDC) outside expert panel and final recommendation from the agency director, Rochelle Walensky.

The United States has secured more than 170 million doses of the two injections in a bid to avoid the worst effects of a possible rise in infections as schools reconvene and people spend more time indoors. indoors due to colder weather.

It could be the last COVID vaccine provided free to all Americans, as the government plans to transfer them to the commercial insurance market next year. Read more

Moderna’s revamped vaccine has been licensed for people ages 18 and older, while the Pfizer/BioNTech vaccine will be available for people ages 12 and older, the FDA said.

Pfizer said it had doses ready to ship immediately and could deliver up to 15 million doses by September 9. Moderna said it expects its new vaccine to be available “within the next few days.”

People pose with a syringe with a needle in front of the Moderna logo displayed in this illustration taken December 11, 2021. REUTERS/Dado Ruvic/Illustration/Files

Experts said updated vaccines will be important for the elderly and those with compromised immune systems, but noted that there is limited data to support the level of protection the government is hoping for.

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

This fall’s revaccination campaign is expected to target many more people than previous boosters cleared by the FDA earlier this year. Concerns about the long COVID were one reason younger, healthier Americans should get vaccinated, officials said.

“If anything is going to prevent transmission and the long COVID, it will be a variant-specific vaccine for the variant that is currently circulating,” said FDA Commissioner Robert Califf.


About 50% of people over the age of 12 in the United States — some 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 booster just two months after a previous injection, saying a longer interval would improve immune responses. FDA officials said the vast majority of Americans are more than two months away from their last shot.

Other countries, including Canada and the United Kingdom, have also ordered updated Omicron vaccine boosters for fall campaigns, although some have purchased vaccines suitable for the BA.1 Omicron subvariant which caused the record increase in COVID cases last winter.

In June, the FDA asked vaccine makers to match vaccines to the BA.4/BA.5 subvariants of the virus responsible for the most recent outbreak of infections worldwide. The BA.5 subvariant accounts for more than 88% of infections in the United States.

Vaccine makers have not completed testing of updated boosters based on BA.4/BA.5 in humans. The FDA bases its decision on safety and efficacy data from the original injections as well as clinical trials conducted on boosters using the BA.1 Omicron subvariant.

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Reporting by Mrinalika Roy in Bengaluru, Julie Steenhuysen in Chicago and Michael Erman in Maplewood New Jersey; Additional reporting by Ahmed Aboulenein in Washington; Editing by Caroline Humer and Bill Berkrot

Our standards: The Thomson Reuters Trust Principles.

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