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 approved updated COVID-19 booster shots from Pfizer (PFE.N)/BioNTech (22UAy.DE) and Moderna targeting the dominant BA.4 and BA. 5 Omicron subvariants , as the government prepares for a broad fall vaccination campaign that could begin in days.

The new vaccines also contain the original version of the virus that all previous COVID injections have targeted.

The FDA approved the injections for anyone 12 years and older who has had a primary vaccination course and is at least two months away from a previous booster injection, shorter than previously recommended intervals.

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dr. Peter Marks, a senior FDA official who oversees vaccines, said he hopes the injections will restore the very good protection against symptomatic diseases that the original vaccines offered when they were launched in late 2020 and early 2021.

“We’re not sure yet if we’ll get to the same level, but that’s the goal here,” said Marks.

The government has begun the fall rollout, which could begin shortly after the US Centers for Disease Control and Prevention’s (CDC) external expert panel meets Thursday and the agency’s director Rochelle Walensky makes a final recommendation.

The United States has secured more than 170 million doses of the two shots in an effort to avert the worst effects of a potential rise in infections as schools reunite and people spend more time indoors due to colder weather.

This could be the last COVID vaccine to be provided for free to all Americans as the government plans to move them to the commercial insurance market next year. read more

Moderna’s updated vaccine is approved for individuals ages 18 and older, while the Pfizer/BioNTech injection will be available for individuals ages 12 and older, the FDA said.

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

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

Experts have said the updated vaccines will be important for older people and immunocompromised people, but noted there is limited data to support the level of protection the government is hoping for.

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

This fall’s revaccination campaign is expected to target many more people than the previous boosters approved by the FDA earlier this year. Concern about long-term COVID was one reason younger and healthier Americans should be given the opportunity, officials said.

“If anything is going to prevent transmission and long-term COVID-19, it will be a variant-specific vaccine for the variant currently circulating,” said FDA Commissioner Robert Califf.


About 50% of those in the United States over the age of 12 — some 107 million people — have received at least one COVID-19 booster dose to date.

Some scientists were critical of the recommendation to allow a new booster just two months after a previous injection, saying that a longer period of time would improve the immune response. FDA officials said the vast majority of Americans are significantly more than two months away from their most recent admission.

Other countries, including Canada and the UK, have also ordered updated Omicron vaccine boosters for fall campaigns, although some have purchased shots tailored to the BA.1 Omicron subvariant that caused the record surge in COVID cases last winter.

In June, the FDA asked vaccine makers to tailor injections to the BA.4/BA.5 subvariants of the virus that are responsible for the most recent increase in infections worldwide. The BA.5 subvariant is responsible for more than 88% of US infections.

The vaccine makers have not completed testing of the updated BA.4/BA.5-based boosters in humans. The FDA bases its decision on safety and efficacy data from the original shots and from clinical studies 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 coverage by Ahmed Aboulenein in Washington; Editing by Caroline Humer and Bill Berkrot

Our Standards: The Thomson Reuters Trust Principles.

The Valley Voice
The Valley Voicehttp://thevalleyvoice.org
Christopher Brito is a social media producer and trending writer for The Valley Voice, with a focus on sports and stories related to race and culture.


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