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

This move came a day later Pfizer and BioNTech . introduced Their application for an updated Covid-19 EUA for people 12 and older.

If the updated vaccines are approved by the U.S. Food and Drug Administration (FDA), they may become available in September. The companies’ updated formulations are bivalent vaccines that combine the original vaccines with those targeting the omicron sub-strains BA.4 and BA.5, which are currently dominant in the United States. The Moderna dose will be given as a dose of 50 mcg, while the dose of Pfizer will be given as a dose of 30 mcg.

Moderna said Tuesday that phase 2/3 clinical trials of these boosters are now underway. The data I have provided to the FDA comes from experiments in mice as well as from data from humans using a different enhancer that has been updated to protect against the BA.1 strain of Omicron.

“We have worked closely with the FDA to ensure Americans have access to Moderna’s updated bivalent booster, which, if permitted, could provide higher, broader and more lasting protection against Covid-19 than the currently authorized booster.” . Stefan Bancel, CEO of Moderna.

Next, the FDA will evaluate the data from Moderna and Pfizer and decide whether or not to allow the shots.

“The FDA will use the totality of available evidence to allow bivalent fall enhancers,” FDA spokeswoman Abigail Capobianco said in a statement emailed to CNN last week. “There are data on several million individuals who received the prototype component as a booster. As for the BA.4/5 component, which is a combination of non-clinical data obtained in mice, and data from previous variant vaccines (including beta and delta vaccines, and omicron BA.1), along with our extensive knowledge of the safety and efficacy of mRNA platforms to make this decision.”

When shots are available

The White House Covid-19 Response Coordinator Dr. Ashish Jha said the updated boosters should be available to the public as early as mid-September, but it is ultimately up to the Food and Drug Administration as to when the shot gets the go-ahead.

Dr. Peter Marks, director of the Food and Drug Administration’s Center for Evaluation and Research in Biology, said in an interview with The The New York Times On Tuesday, the agency said that the agency would not hold a meeting of the independent panel of vaccine experts to get a recommendation on whether to authorize updated shots for Covid-19.

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

The 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. Centers for Disease Control Immunization Practices Advisory Committee Meetings are scheduled for Thursday, September 1, and Friday, September 2.

The CDC committee usually meets after vaccines have been authorized by the U.S. Food and Drug Administration (FDA). The injection can only be given after the CDC recommends it.

Updated footage is already being produced, and countries can already order it. The US government has purchased 105 million booster doses of the bivalent Covid-19 vaccine from Pfizer, and another 66 million updated doses from Moderna.

Some residents are eligible to receive boosters I and II for current Covid-19 vaccines.

Director of the Center for Disease Control Dr. Rochelle Walinsky said on NBC’s Today show Tuesday that the agency is willing to take action on the updated boosters if the FDA allows them, but that people who already qualify for a booster dose should get it now.

“I would say, there is no bad time to go ahead and get a booster if you qualify,” Walinsky said. “If you’re over 50 and haven’t gotten that second boost, you can still go ahead and get it now.”