On Wednesday, Moderna announced that it has submitted preliminary data to the U.S. Food and Drug Administration (FDA) seeking authorization for the administration of a third booster dose of its COVID-19 vaccine in the United States. Stéphane Bancel, the CEO of Moderna, stated in a press release, "We are pleased to begin the licensing request process," assuring that his company will "stay ahead of the virus."
Bancel explained that the American biotechnology company provided the agency with the results of tests conducted on nearly 350 participants who received the booster dose six months after their second dose. According to the statement, this booster dose contains 50 micrograms of the vaccine, which is half the amount of the first and second doses.
Moderna noted that antibody levels fighting the virus "decreased significantly" after "about six months" from the second dose. It added that "after a third dose, a similar level of antibodies was reached," which applies to all age groups. Regarding the body's reactions to this booster dose, they are similar to the first two doses.
Moderna indicated that it would submit "in the coming days" this data to the European Medicines Agency and other regulatory bodies worldwide. The Pfizer/BioNTech alliance had submitted preliminary data to the U.S. FDA in mid-August seeking authorization for a third booster dose of their COVID-19 vaccine.
On Wednesday, the FDA announced that an advisory committee will meet on September 17 to "discuss the issue of administering additional doses of COVID-19 vaccines," specifically considering Pfizer's request to administer this dose to individuals aged 16 and older. The opinion of this committee is required to grant or deny the authorization. U.S. health authorities announced at the end of August that they would launch a campaign starting September 20 to administer a third booster dose of the Pfizer and Moderna vaccines to all Americans.
