The updated Pfizer-BioNTech and Moderna COVID-19 boosters have received the green light from the U.S. Food and Drug Administration (FDA) for “use as a single booster dose at least two months following primary or booster vaccination,” the FDA said on Wednesday.
“The COVID-19 vaccines, including boosters, continue to save countless lives and prevent the most serious outcomes (hospitalization and death) of COVID-19,” said FDA Commissioner Robert M. Califf, M.D. “As we head into fall and begin to spend more time indoors, we strongly encourage anyone who is eligible to consider receiving a booster dose with a bivalent COVID-19 vaccine to provide better protection against currently circulating variants.”
The FDA approved the doses for individuals aged 12 and up who have completed the main immunization series and who are at least two months removed from a previous booster shot, which is two months shorter than the previously recommended interval, Reuters reported.
Dr. Peter Marks, a top FDA official in charge of vaccinations, said he thinks the injections would restore the original vaccines’ extremely strong protection against symptomatic illness when they were released in late 2020 and early 2021.
It is the first time the FDA has approved a new vaccination mix since the first doses were introduced in December 2020.
The FDA called for the fall booster campaign to target Omicron, as Bio.News reported in June. The new boosters will likely be available in pharmacies following Labor Day weekend.
According to the Health and Human Services Department, 171 million doses of Pfizer-BioNTech’s and Moderna’s updated vaccines have already been distributed in the United States, CNBC reports.
“For each of the bivalent COVID-19 vaccines authorized today, the FDA evaluated immunogenicity and safety data from a clinical study of a booster dose of a bivalent COVID-19 vaccine that contained a component of the original strain of SARS-CoV-2 and a component of omicron lineage BA.1. The FDA considers such data as relevant and supportive of vaccines containing a component of the omicron variant BA.4 and BA.5 lineages. Furthermore, data pertaining to the safety and effectiveness of the current mRNA COVID-19 vaccines, which have been administered to millions of people, including during the omicron waves of COVID-19, contributed to the agency’s evaluation,” the FDA said.