Moderna has submitted its request to the U.S. Food and Drug Administration for emergency use authorization of its updated Covid-19 vaccine booster for use in people ages 18 and older, a the company said in a press release Tuesday.
This updated formulation is a bivalent vaccine that will combine the original vaccine with one targeting the Omicron BA.4 and BA.5 sublines, and would be administered at a dose of 50 micrograms.
The company indicates that a phase 2/3 clinical trial on these boosters is currently underway. The data they submitted to the FDA comes from mouse experiments as well as human data using a different booster that was updated to protect against Omicron’s BA.1 strain.
“We have worked closely with the FDA to ensure that Americans will have access to Moderna’s updated bivalent booster, which, if cleared, may provide higher, broader, and longer-lasting protection against Covid-19. 19 compared to the currently authorized booster,” said Stéphane Bancel, CEO of Moderna.
The announcement comes a day after Pfizer and BioNTech said they had submitted their request to the US Food and Drug Administration for emergency use authorization of their bivalent Covid-19 booster for use in the elderly. 12 years and older.
White House Covid-19 response coordinator Dr. Ashish Jha said recently that the updated boosters should be available to the public in early to mid-September, but it’s ultimately up to the FDA to decide. when the shot will be given the green light.
“The FDA will use the totality of available evidence to authorize fall bivalent recalls,” FDA spokeswoman Abigail Capobianco said in a statement sent to CNN last week. “There is data on several million individuals who received the prototype component as a booster. For the BA.4/5 component, a combination of non-clinical data obtained in mice, data from previous variant vaccines ( including those against beta, delta and omicron BA.1), as well as 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 Omicron BA.4 and BA.5 subvariants in all participants, regardless of prior infection,” according to data previously published by Moderna. in June.
The FDA will now assess Moderna’s data, but has not said whether it will call its vaccine advisers before making a decision on authorization. Such a measure could delay the time when injections can be administered.
Production of updated plans is already underway. The US government has purchased 105 million booster doses of bivalent Covid-19 vaccine from Pfizer and 66 million updated vaccines from Moderna.