Protection file

Pfizer asks FDA to approve COVID booster dose that adds protection against Omicron, BA.4, BA.5 variants

Pfizer on Monday asked U.S. regulators to clear its combined COVID-19 vaccine that adds protection against new omicron relatives — a key step toward opening a fall recall campaign.

The Food and Drug Administration has ordered vaccine makers to adjust their vaccines to target BA.4 and BA.5 which are better than ever at dodging immunity from previous vaccination or infection.

Pfizer and partner BioNTech aim to offer updated reminders to people 12 and older, and injections could begin within weeks if the FDA clears the modified vaccine quickly — a step that shouldn’t require waiting for news. studies.

Moderna is expected to file a similar request soon for updated boosters for adults. The United States has a contract to buy 105 million Pfizer doses and 66 million Moderna doses, assuming the FDA gives the green light.

“It will be very important for people to get the new vaccines this fall and winter. 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 is currently the source of nearly all COVID-19 infections in the United States and much of the world. There’s no way to tell if he’ll still be a threat this winter – or if another mutant will have replaced him.

Vaccines currently in use in the United States still offer strong protection against serious illness and death, especially if people have received the recommended boosters. But these vaccines target the strain of coronavirus that spread in early 2020, and their effectiveness against infection has drastically diminished as new mutants have emerged, particularly the super-contagious omicron family.

How would Combined Fire work? Sort of like a second generation vaccine. 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 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 allow a different update to Moderna’s COVID-19 vaccines – shots that add protection against the original omicron that has hit last winter.

European regulators are also considering the original versions of omicron from Moderna and Pfizer. The United States chose not to use this earlier change – implementing a dropout where different countries will use different versions of dropouts to strengthen protection against another possible winter surge.

In the United States, the FDA will rely heavily on scientific testing of previous adjustments to the vaccine recipe – rather than a study of new boosters which could take months – to decide whether or not to accelerate updates to vaccines. vaccines for the fall.

Pfizer previously announced the results of a study which found that its first tweak of the omicron significantly accelerated antibodies capable of fighting the first version of the omicron, called BA.1, and to a lesser extent the genetically related relatives. distinct from omicron BA.4 and BA.5. Its application to the FDA contains this data as well as the animal testing of the latest recipe update.

It’s similar to how flu vaccines are updated every year without having to undergo large studies.

Pfizer and BioNTech plan to begin a trial using the BA.4 and BA.5 boosters in the coming weeks to shed additional light on how the modified shots work. Moderna has started a similar study, though full results won’t be available until a fall recall campaign.

“It’s clear that none of these vaccines will completely prevent infection,” said Dr. Rachel Presti of Washington University in St. Louis, researcher of the Moderna trial.

But previous studies of candidate booster variants show that “you always get a broader immune response from giving a booster variant than from giving the same booster,” which should be useful even if a new omicron parent emerges, a- she added.

Pfizer and Moderna don’t make the only vaccine options in the United States. Novavax makes a more traditional protein-based injection – and US health authorities have just extended its use to people as young as 12 years old. Novavax also plans to release a variant update later this year.

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