By targeting newest variants US clears updated COVID boosters

On Wednesday, the first to directly target today’s most common omicron strain, U.S. regulators authorized updated COVID-19 boosters. Further, the shots could begin within days.  

The move was tweaked by the Food and Drug Administration, the recipe of shots made by Pfizer and rival Moderna that have already saved millions of lives. 

However, the hope is that the modified boosters will blunt yet another winter surge and help to tamp down the BA.5 omicron relative that continues to spread widely.

Dr. Robert Califf, FDA Commissioner said that these updated boosters present us with an opportunity to get ahead of the next COVID-19 wave.

Until now, the original coronavirus strain has targeted the COVID-19 vaccines, even as wildly different mutants emerged. The new U.S. boosters are combination, or “bivalent,” shots. Against the newest omicron versions, BA.4 and BA.5, that are considered the most contagious yet they contain half that original vaccine recipe and half protection.

Against multiple variants the combination aims to increase cross-protection. Moreover, it really provides the broadest opportunity for protection, Pfizer vaccine chief Annaliesa Anderson told The Associated Press. 

By using the original vaccines the updated boosters are only for those people who have already had their primary vaccinations. Moderna’s updated shots are for adults if it has been at least two months since their last primary vaccination or their latest booster while doses  for anyone 12 and older made by Pfizer and its partner BioNTech. They are not to be used for initial vaccinations.  

Before a fall booster campaign begins there is one more step: For Disease Control and Prevention the centers must recommend who should get the additional shot. From COVID-19 an influential CDC advisory panel will debate the evidence on Thursday including whether people at high risk should go first. 

More than 170 million doses the U.S. has purchased from the two companies. By the end of next week Pfizer said it could ship up to 15 million of those doses. Moderna didn’t immediately say how many doses are ready to ship in the coming days but that some will be available.

Moreover, the big question arises is whether people weary of vaccinations will roll up their sleeves again. The first recommended booster dose just half of vaccinated Americans got, and only a third of those 50 and older who were urged to get a second booster did so.

For generally healthy people, especially if they got that important first booster dose the original vaccines still offer strong protection against severe disease and death from COVID-19. In antibodies capable of fending off an omicron infection it’s not clear just how much more benefit an updated booster will bring beyond a temporary jump. 

This is a different kind of booster still, “people have to realize this than was previously available. At protecting against omicrons it will work better,” said virologist Andrew Pekosz of the Johns Hopkins Bloomberg School of Public Health.

“Even if you’ve been infected in the last year people who had an earlier omicron version still can get reinjected so you should definitely go for the booster”, Pekosz added. “If we can get good buy-in to use this, we might really be able to make a dent”, he thinks in COVID-19 cases.

A step toward eventually handling COVID-19 vaccine updates more like yearly changes to flu shots, the FDA cleared the modifications ahead of studies in people.

“The totality” of evidence FDA vaccine chief Dr. Peter Marks stressed the agency considered. To match earlier mutants including the omicron strain named BA.1 that struck last winter and tested them in people both Pfizer and Moderna have previously brewed vaccine doses. Those earlier recipe changes were safe, and the BA.1 version substantially boosted virus-fighting antibodies more than another dose of the original vaccine  although fewer that recognized today’s genetically distinct BA.4 and BA.5 strains.

To brew even more up-to-date doses that target those newest omicron mutants, FDA ordered the companies, instead of using those BA.1 shots sparking a race to roll them out. Marks said the latest update spurs showed animal tests “a very good immune response rather than waiting a few more months for additional human studies of that very similar recipe tweak.” 

Marks said that “The immune system with what is actually circulating one needs to refresh”. Due to this, with the original recipe for those 12 and older FDA also is no longer authorizing boosters.

Currently spreading variants might do a better job fighting infection, Marks said, the hope is that a vaccine matched, not just serious illness, at least for a while.

Moderna and Pfizer are conducting human studies to help assess their value, even as modified shots roll out, including how they hold up if a new mutant comes along.

Pfizer plans to ask the FDA to allow updated boosters and for children for 5- to 11-year-olds in early October.

To the COVID-19 vaccine recipe it’s the first U.S. update, an important but expected next step like how flu vaccines get updated every year. This report has been contributed by AP Health Writer Matthew Perrone.

From the Howard Hughes Medical Institute’s Department of Science Education the Associated Press Health and Science Department receives support. The AP is solely responsible for all content.

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