Moderna, Pfizer seek FDA authorization for updated Covid-19 vaccines; shots could be available next month

By Carma Hassan and Brenda Goodman, CNN

Moderna submitted its application to the US Food and Drug Administration for emergency use authorization of its updated Covid-19 vaccine booster for use in people age 18 and older, the company said in a news release on Tuesday.

The move came one day after Pfizer and BioNTech submitted their application for EUA of their updated Covid-19 booster for people age 12 and older.

If the FDA authorizes the updated vaccines, they could become available in September. The companies’ updated formulations are bivalent vaccines that combine the original vaccines with ones that target Omicron sublineages BA.4 and BA.5, which currently dominates in the United States. Moderna’s shot would be administered as a 50-microgram dose, and Pfizer’s as a 30-microgram dose.

Moderna said Tuesday a Phase 2/3 clinical trial on these boosters is now underway. The data it submitted to the FDA comes from experiments in mice as well as data from humans using a different booster which was updated to protect against the BA.1 strain of Omicron.

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

Next, the FDA will evaluate the data from Moderna and Pfizer and decide whether to authorize the shots.

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

When shots could be available

White House Covid-19 Response Coordinator Dr. Ashish Jha has said the updated boosters should be available to the public early- to mid-September, but it is ultimately up to the FDA as to when the shot will get the greenlight.

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in an interview with the New York Times on Tuesday that the agency will not convene its independent panel of vaccine experts to seek a recommendation on whether to authorize updated Covid-19 shots.

Marks told the Times the FDA has “extremely good” data that he is “extremely confident” about that shows the shots are safe and will be effective, even though the formulations for the updated boosters have not been tested in humans.

Independent experts who advise the US Centers for Disease Control and Prevention on its vaccine recommendations are expected to discuss updated Covid-19 vaccines during meetings next week. The CDC’s Advisory Committee on Immunization Practices meetings are scheduled for Thursday, September 1, and Friday, September 2.

The CDC committee typically meets after vaccines have been authorized by the FDA. Shots can be administered only after the CDC recommends them.

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

Certain populations are eligible to receive first and second boosters of the existing Covid-19 vaccines.

CDC Director Dr. Rochelle Walensky said on NBC’s Today on Tuesday that the agency is prepared to take action on updated boosters if the FDA authorizes them, but people already eligible for a booster shot should get one now.

“I would say, there’s never a bad time to go ahead and get your booster if you’re eligible,” Walensky said. “If you’re over the age of 50 and you haven’t gotten that second booster, you can still go ahead and get it now.”

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