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

by | Aug 24, 2022 | COVID-19

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 availableWhite House Covid-19 Response Coordinator Dr. Ashish Jha has said the updated boosters …

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