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The FDA is requesting COVID boosters to combat Omicron’s BA.4, BA.5 sub-variants

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On Thursday, the US Food and Drug Administration recommended that COVID-19 vaccine manufacturers change the design of their revaccinations earlier this fall to include components adapted to combat the currently dominant Omicron BA.4 and BA.5 coronavirus sub-variants.

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If approved, the changes would mean the first major overhaul of COVID vaccines, but could also slow their deployment because the FDA recommended a design somewhat different from what companies have already tested and started manufacturing.

The FDA will not require new studies testing the BA.4 / BA.5 vaccine in humans to be completed for approval, a top agency spokesman told Reuters, as the annual changes to flu vaccines are being ressed.

“In a sense, we’re chasing the virus, just as we do with the flu, and how close we can get to the variants that are prominent at the time, we’ll have to wait and see,” Dr. William Schaffner. An infectious disease specialist at Vanderbilt University Medical Center ed that the revised vaccines could provide better protection than current ones.

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The FDA said companies would not have to change the vaccine for the primary vaccination series, as the coming year will be “a transitional period when this modified booster vaccine can be introduced.”

The new booster doses would be bivalent vaccines targeting both the parent virus and Omicron subvariants.

The decision follows a recommendation from the agency’s external advisers to change the vaccine proposal this autumn to combat more frequent versions of coronavirus.

It is estimated that BA.4 and BA.5, according to the US Centers for Disease Control and Prevention, account for more than 50% of infections in the United States and have become dominant elsewhere.

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The FDA said Thursday that it hopes the modified vaccines could be used early in mid-autumn.

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The researchers suggested that overworked boosters could elicit a wider range of immune responses, which could also protect against future variants that may arise.

“Predicting the future, especially with COVID-19, is dangerous because COVID has pretended to take us on many occasions,” Schaffner said.

DIFFERENT STRATEGIES FOR DIFFERENT COUNTRIES

Regulators from other countries are seriously considering the use of new boosters based on the BA.1 Omicron variant, which caused a massive increase in cases last winter, FDA chief executive Dr. Peter Marks.

“Some may want the vaccine faster.” The (vaccine) will be available faster, “Marks said after Thursday’s meeting of international regulators.

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The World Health Organization’s advisers preferred BA.1 -based boosters, with the variant being clearer and likely to elicit a broader response than recently circulating subvariants.

Pfizer Inc, partnering BioNTech SE and Moderna Inc, have tested versions of their vaccines adapted to combat the BA.1 Omicron variant.

Although they reported that these vaccines elicited a good immune response against BA.1 and newer circulating variants, they reported a lower response against BA.4 and BA.5.

The companies were already producing their BA.1 vaccines and said on Tuesday that the transition to the BA.4 / BA.5 design could delay their introduction.

Pfizer / BioNTech, which on Wednesday announced a $ 3.2 billion contract to deliver more doses of COVID to the United States, said it would have a significant amount of BA.4 / BA.5 ready for distribution by the first week of October.

Moderna said it would be in late October or early November before her modified vaccine was ready.

The FDA has ordered manufacturers to begin clinical trials to study BA.4 / 5 vaccines, but said it will evaluate data on its previous BA.1-based vaccines to support the approval of revised vaccines.

Marks said the data from the new study will be important to assess the continued effectiveness of boosters against new variants that may emerge.

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