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U.S. FDA authorizes two COVID boosters targeted at Omicron subvariants

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

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Aug 31 (Reuters) – The U.S. Food and Drug Administration on Wednesday authorized updated COVID-19 booster vaccines from Pfizer (PFE.N)/BioNTech (22UAy.DE) and Moderna targeting the dominant BA.4 and BA.5 Omicron sub-variants, as the government prepares for a fall vaccination campaign that could start within days.

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

The FDA has authorized the shots for everyone over the age of 12 who has had a series of primary vaccinations and at least two months have passed since a previous booster vaccination, shorter than the previously recommended intervals. That marks a change from current vaccines based only on the original virus that are available to people 50 and older or who are immunocompromised.

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Moderna’s modified vaccine is licensed for ages 18 and older, while the Pfizer/BioNTech shot will be available for ages 12 and older, the FDA said.

“As we head into fall and begin to spend more time indoors, we strongly encourage anyone who qualifies to consider receiving a booster dose with a COVID-19 (mourning-targeted) vaccine to provide better protection against the variants currently circulating,” said FDA Commissioner Robert. Califf said in a statement.

Experts have said the updated vaccines will be important for the elderly and the immunocompromised, but said there is limited data to support the level of protection promised by the government.

“The idea is that they want protection against infection to build up as quickly as possible in the population, but it’s not yet clear how clinically effective these vaccines are against BA.5 infection, and whether a shorter waiting period will affect efficacy due to interference from prior immunity,” said Dr. Amesh Adalja, an infectious disease expert at the Johns Hopkins Center for Health Security in Baltimore.

The government has already begun work on the fall implementation, which could begin in the coming days after the US Centers for Disease Control and Prevention (CDC) panel of outside experts meets on Thursday. and agency director Rochelle Walensky make a final recommendation.

Pfizer said it has some doses ready to ship immediately and may deliver up to 15 million doses by September 9.

The US government has secured 105 million doses of Pfizer’s updated injections and 66 million doses from Moderna to stave off the worst effects of a likely surge in infections as schools reconvene and people move more time indoors as the weather gets colder.

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

In June, the FDA set itself apart from other countries when it asked vaccine makers to adapt vaccines to the BA.4/BA.5 sub-variants of the virus that are responsible for the latest surge in infections worldwide. The BA.5 subvariant accounts for more than 88% of infections in the US.

Vaccine manufacturers 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 injections, as well as clinical trials conducted with boosters using the BA.1 Omicron subvariant.

“We are confident in the evidence supporting these authorizations,” said Dr. Peter Marks, a senior official who oversees vaccines at the US FDA.

Dr. Gregory Poland, a vaccine expert at the Mayo Clinic, said the new shots are unlikely to help people who have recently been infected.

“Your biggest advantage will be in those who are not vaccinated or who are not fully vaccinated, or who are immunocompromised,” he said.

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

Our standards: The Thomson Reuters Trust Principles.

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