FDA has authorized booster shots of the Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) and Moderna (NSDQ:MRNA) vaccines for everyone 18 and older.
Assuming CDC backs the decision, tens of millions of American adults who received two doses of the two mRNA COVID-19 vaccines at least six months ago will be eligible for boosters.
“Authorizing the use of a single booster dose of either the Moderna or Pfizer-BioNTech COVID-19 vaccine for individuals 18 years of age and older helps to provide continued protection against COVID-19, including the serious consequences that can occur, such as hospitalization and death,” said Acting FDA Commissioner Dr. Janet Woodcock, in a news release.
CDC is hosting a meeting of external advisors today to make recommendations concerning boosters for all adults.
The Biden administration has hoped federal officials would authorize boosters for months.
Some independent advisors to the FDA and CDC — and some employees of those agencies — had criticized what they perceived as an unwarranted rush from the administration to greenlight boosters.
In late August, two senior vaccine leaders within the FDA announced their plans to retire from the administration. The two were co-authors of an October Lancet article arguing for a conservative approach for administering COVID-19 boosters.
In September, FDA and CDC authorized COVID-19 vaccine boosters for certain high-risk groups.
Recipients of a single dose of the Janssen COVID-19 vaccine are already eligible for a booster dose at least two months after the administration of the vaccine.
Filed Under: clinical trials, Drug Discovery, Infectious Disease
