Pfizer Inc. and BioNTech SE asked the U.S. to authorize a new COVID-19 booster shot customized against the currently circulating COVID-19 variants as governments race to protect their populations against the ever-mutating virus.
In a statement, the companies said they had “rapidly scaled production” for the new booster and would be able to ship doses of the new vaccine “immediately” upon emergency authorization. The new shot contains mRNA for the original COVID-19 spike protein, as well as mRNA for the BA.4/BA.5 subvariants of omicron. Currently BA.5, a newer evolution of omicron, is by far the dominant variant circulating in the U.S.
Pfizer’s new booster that’s up for authorization in the U.S. hasn’t yet been tested in people in a clinical trial, though the company said it will start this month. It’s all part of a push to use mRNA technology, which allows for faster drug development, to respond more quickly to changes in the virus and better guard against future COVID-19 surges. The virus has mutated so quickly, it has been hard for government and drug companies to keep up.
Both Pfizer and its rival Moderna Inc. had originally developed and tested boosters containing the original omicron strain. Last week the UK authorized an omicron-specific booster from Moderna that targets that variant, which emerged in the fall and caused waves of cases around the world.
As new omicron subvariants continued to emerge, U.S. regulators in late June advised vaccine manufacturers to develop COVID-19 boosters that include components targeting the newer mutations.
The U.S. Food and Drug Administration’s decision came after a panel of experts overwhelmingly voted in favor of updating the vaccine boosters in response to the evolving virus. That paved the way for manufacturers, including Pfizer and Moderna, to incorporate BA.4/BA.5 elements into booster doses.
Pfizer’s application to the FDA includes data from its human trials of the original omicron BA.1 booster, along with lab and manufacturing data from its bivalent vaccine targeting BA.4/BA.5.
The U.S. Food and Drug Administration didn’t immediately respond to a request for comment.
A conditional marketing authorization application for Pfizer’s new shot has also been initiated in Europe, the companies said. The shot is intended for use in individuals 12 and older, Pfizer said.
(Updates with details of boosters starting in third paragraph.)
