HomeBusinessModerna seeks FDA authorization for updated Covid-19 booster

Moderna seeks FDA authorization for updated Covid-19 booster

This updated formulation is a bivalent vaccine that combines the original vaccine with a vaccine targeting Omicron sublines BA.4 and BA.5, which would be administered as a 50 microgram dose.

The company says a Phase 2/3 clinical trial of these boosters is now underway. The data they submitted to the FDA comes from experiments on mice and data from humans using a different booster that has been updated to protect against the BA.1 strain of Omicron.

“We have been working closely with the FDA to ensure Americans have access to Moderna’s updated, bivalent booster, which, if authorized, could provide higher, broader and more durable protection against Covid-19 compared to the currently authorized booster,” said Stephane Bancel, Moderna’s Chief Executive Officer.

The announcement comes a day after Pfizer and BioNTech said they had filed with the U.S. Food and Drug Administration for emergency authorization of their bivalent Covid-19 booster for use in people 12 years and older.

When could recordings be available?

dr. Ashish Jha, the White House’s Covid-19 response coordinator, recently said the updated boosters should be available to the public in early to mid-September, but it’s ultimately up to the FDA to determine when the shot gets the green light.

“The FDA will use all available evidence to approve the bivalent fall boosters,” FDA spokesman Abigail Capobianco said in a statement emailed to CNN last week. “There are data on many millions of individuals who received the prototype component as a booster. As for the BA.4/5 component, a combination of non-clinical data obtained in mice, data from previous variant vaccines (including those for beta, delta – , and omicron BA.1), together with our extensive knowledge of the safety and efficacy of the mRNA platforms will be used for this decision making.”

The booster dose “elicited potent neutralizing antibody responses against the Omicron subvariants BA.4 and BA.5 in all participants, regardless of prior infection,” according to data released earlier in June by Moderna.

The FDA will now evaluate Moderna’s data, but has not said whether it will convene its vaccine advisors before making a decision on approval. Such a step could push back when shots can be administered.

Production of the updated recordings is already underway. The US government has purchased 105 million bivalent Covid-19 vaccine booster doses from Pfizer and another 66 million updated injections from Moderna.

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