FDA green lights Omicron-targeting mRNA vaccine boosters

The Biden administration is set to roll out a campaign for the single-dose booster after Labor Day.
A gloved hand drawing a vaccine.
New COVD vaccine boosters will be available in a single dose and target two strains of the virus. Vcolvacik/Deposit Photos

The Food and Drug Administration (FDA) has authorize Pfizer-BioNTech and Moderna’s new bivalent COVID-19 booster shots. The new vaccines, which the FDA will also call “updated boosters,” contain two messenger RNA (mRNA) components: one targets the original strain of the virus and the other targets omicron’s extremely contagious BA.5 subvariant that is currently responsible for the majority of COVID-19 infections.

The Pfizer-BioNTech vaccine booster is available to anyone 12 and older at least two months after a completed primary vaccination or those who received the third booster shot that only targets the original strain, like the previous boosters from 2021.

[Related: Omicron-specific COVID vaccine approved in the UK.]

The Moderna vaccine is available to anyone over 18 at least two months after the first two doses or if you received a third shot without the booster.

It is important to check vaccination records or with a healthcare provider with any questions about when to receive a booster.

The move comes before the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) meeting, amidst concerns over waning immunity and a potential fall and winter surge of the virus.

“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 in a press release. “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.”

Last week, federal health officials noted to The New York Times that they are eager to deliver updated boosters as quickly as possible, pointing to a death toll that averages about 450 Americans per day. That number could rise in the coming months when the weather gets colder and people spend more time inside.

On August 15, Great Britain became the first country to authorize a bivalent vaccine, where half of a dose targets the original COVID-19 strain and the other half targets BA.5. The vaccine is updated version of Moderna’s original COVID vaccine and generated a good immune response to these two variants, as well as the BA.4 and BA.5 subvariants in adults, in clinical trials.

The FDA asked vaccine manufacturers to tailor new shots that target the two dominant subvariants (BA.4 and BA.5) this past June, adding that the regulatory group would not require studies testing the shots in humans for the vaccines to be authorized. This process is similar to how how annual changes to flu vaccines are handled, as the influenza virus is constantly mutating.

The Biden administration is currently planning a vaccine campaign roll out set to begin after Labor Day.

[Related: If you’re unsure about getting the COVID-19 vaccine, read this.]

According to the FDA, The mRNA in these boosters is a specific piece of genetic material that instructs cells in the body to make the distinctive “spike” protein of the original virus strain and the omicron variant lineages BA.4 and BA.5. The spike proteins of BA.4 and BA.5 are identical.

“We are confident in the evidence supporting these authorizations,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research in a press release. “The public can be assured that a great deal of care has been taken by the FDA to ensure that these bivalent COVID-19 vaccines meet our rigorous safety, effectiveness and manufacturing quality standards for emergency use authorization.”

Correction: A previous version of this post said the FDA decision followed the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP). The CDC committee will be held on September 1.