WASHINGTON (AP) Pﬁzer asked U.S. regulators Monday to authorize its combination COVID19 vaccine that adds protection against the newest omicron relatives — a key step toward opening a fall booster campaign. The Food and Drug Administration ordered vaccine makers to tweak their shots to target BA.4 and BA.5 that are better than ever at dodging immunity from earlier vaccination or infection.
Pﬁzer and its partner BioNTech aim to offer updated boosters to people 12 and older, and shots could begin within weeks if the FDA quickly clears the modiﬁed vaccine — a step not expected to require waiting on new studies.
Moderna is expected to ﬁle a similar application soon for updated boosters for adults. The U.S. has a contract to buy 105 million of the Pﬁzer doses and 66 million Moderna ones, assuming FDA gives the green light.
“It’s going to be really important that people this fall and winter get the new shots. It’s designed for the virus that’s out there,” White House COVID-19 coordinator Dr. Ashish Jha said last week.
For now at least. BA.5 currently is causing nearly all COVID-19 infections in the U.S. and much of the world. There’s no way to know if it still will be a threat this winter — or if another mutant will have replaced it.
The vaccines currently used in the U.S. still offer strong protection against severe disease and death, especially if people have gotten their recommended boosters. But those vaccines target the coronavirus strain that spread in early 2020 and their effectiveness against infection has dropped markedly as new mutants came along, particularly the supercontagious omicron family.
How would combo shots work? Sort of like a second-generation vaccine. Both the Pﬁzer and Moderna vaccines contain the genetic instructions for the spike protein that coats the coronavirus, to train the immune system to recognize the real virus. The new combo doses will contain instructions for both the original spike target and the spike mutations carried by BA.4 and BA.5.
The news comes after Britain a week ago became the ﬁrst in the world to authorize a different update to Moderna’s COVID-19 vaccines -shots that add protection against the original omicron that struck last winter.
European regulators also are considering the original omicron versions by Moderna and Pﬁzer. The U.S. opted not to use that earlier tweak — setting up a fall where different countries will be using different versions of booster shots to rev up protection against another possible winter surge.
In the U.S., the FDA will be relying heavily on scientiﬁc testing of prior tweaks to the vaccine recipe — rather than a study of the newest boosters that could take months — to decide whether to fast-track updated shots for fall.
Pﬁzer previously announced results from a study that found its earlier omicron tweak signiﬁcantly revved up antibodies capable of ﬁghting the ﬁrst omicron version, called BA.1, and to a lesser degree the genetically distinct BA.4 and BA.5 omicron relatives. Its application to the FDA contains that data plus animal testing of the newest recipe update.
It’s similar to how flu vaccines are updated every year without having to undergo large studies.
Editor’s Note Prior to publication, the FDA approved the application of Pﬁzer and BioNtech and the application of Moderna. Approval is expected by the CDC by Labor Day.