United States: Moderna has submitted its application to the USA Food and Drug Administration for emergency use authorization of its updated COVID vaccine booster for use in individuals 18 and older, according to the company.
On Tuesday, this step came one day after Pfizer and BioNTech submitted their application for EUA of their updated COVID-19 booster for individuals aged 12 and older.
The new vaccinations may be made accessible in September if the FDA approves them. Bivalent vaccinations, which are the updated formulations of the businesses, combine the original vaccines with those that specifically target Omicron sublineages BA.4 and BA.5, which are presently dominant in the United States. Pfizer’s and Moderna’s shots would each be given in doses of 30 and 50 micrograms, respectively.
A Phase 2/3 clinical trial for these boosters has begun, according to Moderna on Tuesday. Data from both human and mouse studies utilizing a different booster that was modified to provide protection against the BA.1 strain of Omicron were included in the submission to the FDA.
The chief executive officer of Moderna- Stephane Banceml, mentioned in the statement, “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 to the currently authorized booster.”
The FDA will then assess the information provided by Moderna and Pfizer and determine whether to approve the injections.
Along with this, a representative, Abigail Capobianco, outlined in the statement, “FDA will be using the totality of the available evidence to authorize the fall bivalent boosters.”
“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.”
