Pfizer and BioNTech seek emergency authorization for COVID-19 vaccine targeting BA.4 and BA.5 omicron variants

Pfizer and BioNTech have formally requested emergency use authorization for a COVID-19 booster tailored to the omicron BA.4 and BA.5 variants for people ages 12 and up, the companies announced Monday.

In addition to the application to the Food and Drug Administration, the companies are working on a similar request from the European Medicines Agency (EMA), which it expects to finish “in the coming days,” they said in a statement. European regulators are already considering the original omicron-targeted vaccines by both Moderna and Pfizer, The Associated Press noted, while the U.S. opted out of that earlier variation on the shot.

The companies have submitted data required by the FDA “to address the continued evolution of SARS-CoV-2,” they said in a media release. “Pending authorization, the omicron BA.4/BA.5-adapted bivalent vaccine will be available to ship immediately.”

In June, the FDA said any booster shots developed for the fall had to include protection against the newer variants, in particular BA.5, which is driving infections throughout the U.S. as well as the world. Thus the new formula contains the old vaccine, with the two new components added, in what’s known as a “bivalent” formulation. It expands protection while retaining the original benefits.

The current vaccine targets the original iteration of the novel coronavirus and still protects against severe disease and death, though it’s no match for the super-contagion of omicron and its spinoffs. The bivalent version will do that and then some, by specifically targeting the spike protein mutations on the newer, rampaging variants.

“The agility of the mRNA platform, together with extensive clinical experience with the Pfizer-BioNTech COVID-19 Vaccine, has allowed us to develop, test and manufacture updated, high-quality vaccines that align to circulating strains with unprecedented speed,” Pfizer chairman and CEO Albert Bourla said in a statement, adding that the hope was to have the new version ready to combat “potential fall and winter surges.”

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The agility is key for keeping pace with the virus’ mutations, the company leaders said.

“Given the ongoing evolution of SARS-CoV-2 and its variants, it’s of great importance that vaccines can be rapidly adapted to the major circulating omicron lineages,” BioNTech co-founder and CEO Dr. Ugur Sahin said in the joint statement.

“FDA will be using the totality of the available evidence to authorize the fall bivalent boosters,” FDA spokesperson Abigail Capobianco told CNN last week.

Factors influencing the decision-making include data from millions of people who had received the prototype as a booster, as well as data from other studies, Capobianco said.

Moderna, too, is readying its application, the Associated Press reported.

“It’s clear that none of these vaccines are going to completely prevent infection,” Dr. Rachel Presti of Washington University in St. Louis, who is helping research the Moderna trial, told AP. “You still get a broader immune response giving a variant booster than giving the same booster.”

With News Wire Services