WASHINGTON, June 30 (BUS) – U.S. regulators for COVID-19 vaccine makers said Thursday that any fall-modified booster shots should add protection against the newest relative of the omicron, the Associated Press (AP) reported.
The Food and Drug Administration said the original vaccines will be used for anyone still getting the first series of vaccines. But as immunity wanes and the group of highly contagious omicron variants improves in evading protection, the FDA decided that boosters for fall needed an update.
Recipe: Combined doses that add protection against omicron relatives BA.4 and BA.5 to the original vaccine. Together, these transgender people now account for just over half of new infections in the United States.
It’s still a gamble as there’s no way to know if an omicron’s relative remains a threat as cold weather approaches or if it will be replaced by a new one. And the current Pfizer and Moderna vaccines still offer strong protection against the worst outcomes of COVID-19 as long as people have already received recommended boosters.
But the combined approach, which scientists call “bivalent” shots, will allow boosters to retain the proven benefits of the original vaccine while adding to the breadth of protection. It’s a common vaccine strategy: Flu vaccines, for example, can protect against four strains of influenza and are adjusted annually depending on what’s circulating.
It has not been decided whether it must have been the omicron mutant that caused last winter’s eruption or the genetically distinct relatives that replaced it.
Pfizer and Moderna were already brewing and testing the updated boosters against the first omicron mutant in anticipation of its October launch. They found that adding the extra protection was safe — and stimulated the production of more omicron-resistant antibodies than just getting another dose of today’s vaccine.
Pfizer has begun work on another trial dose to target the newer strains that the Food and Drug Administration eventually settled on.
“We are continuing to collect more data from our BA.4/5 study and will contact you as soon as we are ready to provide it,” Pfizer spokeswoman Jerica Bates said in an email.
Moderna told FDA advisors that switching to the newer strains now in circulation could delay its enhanced update by another month. Moderna did not immediately respond to requests for comment on Thursday.
The FDA’s request does not guarantee that these combination shots will be offered in the fall. Manufacturers still have to provide baseline data before the agency can decide whether to allow modified boosters to be used — and the Centers for Disease Control and Prevention will then have to decide how to use them.
Currently, all Americans 5 years of age and older have already been urged to receive the very important first booster of the current vaccine. People 50 years of age or older are eligible for a second booster dose. With omicron, authorities say the shots’ protection against hospitalization from COVID-19, while still strong, has waned in some older adults and a second booster could help restore them.
AOQ