Moderna seeks FDA authorization for updated Covid-19 booster

This updated formulation is a bivalent vaccine that will combine the original vaccine with one targeting Omicron sublineages BA.4 and BA.5, and will be administered as a 50 microgram dose.

The company says that a phase 2/3 clinical trial on these boosters is now underway. The data they have submitted to the FDA comes from experiments on mice, as well as data from humans using a different booster that was updated to protect against the BA.1 strain of Omicron.

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“We have worked closely with the FDA to ensure that Americans will have access to Moderna’s updated bivalent booster, which, if authorized, could offer higher, broader and more durable protection against Covid-19 compared to the currently authorized booster,” said Stephane Bancel, CEO of Moderna.

The announcement comes one day after Pfizer and BioNTech said they submitted their application to the US Food and Drug Administration for emergency use approval of their bivalent Covid-19 booster for use in people 12 years of age and older.

When can images be available?

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

“FDA will use all available evidence to authorize fall bivalent boosters,” FDA spokeswoman Abigail Capobianco said in a statement sent to CNN last week. “There are data on many millions of individuals who have received the prototype component as a booster. In the case of 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.”

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

The FDA will now evaluate Moderna’s data, but has not said whether it will call in its vaccine advisers before making a decision on authorization. Such a step can push back when shots can be fired.

The production of the updated images is already underway. The US government has purchased 105 million bivalent Covid-19 vaccine booster doses from Pfizer, and another 66 million updated shots from Moderna.

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