Vials of the reconditioned Pfizer-BioNTech COVID-19 Booster will be produced at the Kalamazoo, Michigan facility.

Pfizer

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Pfizer

Vials of the reconditioned Pfizer-BioNTech COVID-19 Booster will be produced at the Kalamazoo, Michigan facility.

Pfizer

Vaccine advisors at the Centers for Disease Control and Prevention have approved the first rearranged versions of the Moderna and Pfizer-BioNTech COVID-19 vaccines. There were 13 votes in favor and 1 vote against.

The booster shots target both the original strain of coronavirus and the Omicron BA.4 and BA.5 variants that most people are currently infected with. This double-barrel vaccine is called a bivalent vaccine.

CDC advisers recommended everyone over the age of 12 get the new Pfizer-BioNTech booster approved by the Food and Drug Administration. The updated Moderna COVID-19 vaccine is approved for everyone over the age of 18.

In both cases, you must wait 2 months after completing the first vaccination or final booster. But many vaccine experts say it’s better to wait at least four months after your last vaccination or COVID-19 infection.

This is the first time the FDA has approved a vaccine without requiring human trials. To keep up with the rapidly evolving virus, the FDA relied on how well the injection stimulated the mouse’s immune system. They also looked at how effective similar shots targeting the previous variant were on people.

Companies and federal officials say they have no doubt the shots are safe, and evidence suggests the recalibrated boosters can help reduce the chances of people contracting and spreading the virus. It claims that there is

However, some think it might be better to wait for the results of human studies that are already underway.

At a hearing on Thursday, Dr. Pablo Sanchez, a CDC adviser at Ohio State University, said: “We understand that these variants are constantly changing, but research on BA.4 and BA.5 is ongoing in humans and I think it is a bit premature,” he said. rice field. Sanchez was the only adviser to vote against. “I voted against it because I think we really need human data,” he explained. “There is already a lot of vaccine hesitation. We need human data.”

Other advisors, however, are more comfortable, and flu vaccines are not tested in humans and are updated annually.

“This is the future we are aiming for,” says Dr. Jamie Loehr of Cayuga Family Medicine. “We plan to have more variants, and we have to treat this like the flu, where we can use new strain variants every year,” Loehr said, “even without human data.” , says they have no problem recommending the updated booster.

COVID-19 still kills 400 to 500 people every day in the United States, and public health officials fear another surge this fall or winter. The administration hopes the recalibrated boosters will help contain the surge and protect people from serious illness and death.

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

The final step before the booster rolls out in the US is for CDC Director Rochelle Walensky to release an official statement about the booster. A few shots will be available as early as Friday, with more likely to roll out next week.