Full FDA authorization allows for more physician flexibility when prescribing the vaccine
Nearly two years after the earth-shattering coronavirus pandemic began, the Moderna COVID-19 vaccine has become the second major coronavirus vaccine to be permitted for full use, the Food and Drug Administration (FDA) announced on Monday, Jan. 31.
Previously, the Moderna vaccine — now known as Spikevax — was made available by the FDA under emergency use authorization. The announcement made on Monday follows months of rigorous review by the agency, a standard practice for all vaccines designed for widespread inoculation.
Under the Moderna vaccine’s emergency authorization use period — which began in December 2020 — the biotechnology company administered hundreds of millions of doses, according to the FDA. The coronavirus vaccine from Pfizer and BioNTech received full approval last August, which was granted after months of review.
The Centers for Disease Control and Prevention (CDC) said that more than 204 million doses of the Moderna vaccine have been administered across the U.S. so far with almost 75 million people across the nation having been fully vaccinated with it.
The CDC is expected to meet on Friday, Feb. 4 to review the FDA’s approval and vote whether or not to endorse it. The FDA’s approval on Monday also allows Moderna to officially market the name Spikevax as well as increase flexibility to physicians to prescribe the vaccine; under emergency use authorization, specifics on how vaccines are administered are more restrictive than when they’re granted full FDA approval.
In a statement, FDA Commissioner Janet Woodcock said that while the Moderna vaccine has become a popular option for Americans, “[full] FDA approval of this vaccine may instill additional confidence in making the decision to get vaccinated.”
As reported in the Asian Journal, fully vaccinated individuals became eligible this past fall to receive Moderna booster shots, which are designed to “boost” immunity against disease and infection. The CDC now considers three doses of the vaccine (two full doses and one booster) in order to be “up to date” in a vaccine regimen.
The move to announce full FDA authorization formalizes the agency’s confidence in the vaccine, a move that could influence more Americans to get vaccinated against the coronavirus. Currently, more than 539 vaccine doses (from all available brands) have been administered across the country, with more than 211 million fully vaccinated — 64.1% of the entire population.
California continues to have the most vaccine doses administered per capita with more than 69 million doses given and 27.3 million people fully vaccinated, making 69.1% of the state fully vaccinated. n
