CDC advisers support new recalls to combat omicron: Shots

Vials of the reformulated Pfizer-BioNTech COVID-19 booster pass through production at a plant in Kalamazoo, Michigan.

Pfizer Inc.

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Pfizer Inc.

Vials of the reformulated Pfizer-BioNTech COVID-19 booster pass through production at a plant in Kalamazoo, Michigan.

Pfizer Inc.

Vaccine advisors from the Centers for Disease Control and Prevention have approved early reformulated versions of the Moderna and Pfizer-BioNTech COVID-19 vaccines. The vote was 13 in favor and one against.

The booster shots target both the original strain of the coronavirus and the omicron BA.4 and BA.5 subvariants that most people currently catch. This double-barreled vaccine is called a bivalent vaccine.

CDC advisers have recommended that anyone age 12 and older get the new Food and Drug Administration-cleared Pfizer-BioNTech boosters. The updated Moderna COVID-19 vaccine is licensed for anyone 18 years of age and older.

In either case, people should wait two months after completing their initial vaccination or their last booster shot. But many vaccine experts say it would be best to wait at least four months since the last vaccine or COVID infection, otherwise boosters won’t work as well.

This is the first time the FDA has authorized vaccines without requiring them to be tested on people. To keep track of the virus’ rapid evolution, the FDA relied on the injections’ ability to boost the mice’s immune systems. They also looked at how well similar plans targeted at earlier variants worked on people.

The companies and federal officials say there’s no question the vaccines are safe, and they argue the evidence indicates the reworded reminders will help reduce the chances of people catching the virus and spreading it.

But some people wonder if it wouldn’t be better to wait for the results of human studies that are already underway.

“It certainly looks very promising,” CDC adviser Dr. Pablo Sanchez of Ohio State University said during Thursday’s hearing. “I understand the constant change in these variants, but studies with BA.4 and BA.5 are ongoing in humans and I just wonder if it’s a bit premature,” he said. . Sanchez was the only councilor to vote no. “I voted no because I think we really need human data,” he explained. “There is already a lot of hesitation about vaccines. We need human data.”

But other advisers were more comfortable, pointing out that flu shots are updated every year without being tested on people.

“This is the future we’re heading towards,” says Dr. Jamie Loehr of Cayuga Family Medicine. “We’re going to have more variants and we should treat it like the flu, where we can use new strain variants every year.” Loehr says he’s comfortable recommending the updated boosters, “even though we don’t have human data.”

Between 400 and 500 people still die each day in the United States from COVID-19, and public health officials fear another surge could hit this fall or winter. The administration hopes the reworded reminders will help contain an outbreak and protect people from serious illness or death.

The federal government plans to make boosters available later this week. Ahead of the FDA’s decision, Dr. Ashish Jha, the White House’s COVID-19 response coordinator, told NPR that the new boosters represented “a really important moment in this pandemic.”

The final step before the boosters roll out in the United States is for CDC Director Rochelle Walensky to issue an official statement about them, which should happen soon. A few shots could be available as early as Friday, with a wider rollout next week.

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