Vials of Pfizer-BioNTech’s reformulated COVID-19 booster move through production at a plant in Kalamazoo, Mich.
Pfizer Inc.
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Pfizer Inc.
Vials of Pfizer-BioNTech’s reformulated COVID-19 booster move through production at a plant in Kalamazoo, Mich.
Pfizer Inc.
The Centers for Disease Control and Prevention has approved the first updated COVID-19 booster vaccines.
Earlier in the day, CDC advisers voted to recommend reformulated versions of the Moderna and Pfizer-BioNTech vaccines for COVID-19. The vote was 13 in favor and one against.
“Updated COVID-19 boosters are formulated to better protect against the latest circulating variant of COVID-19,” Walensky said in a written statement announcing the recommendation.
“If you’re eligible, there’s no bad time to get your COVID-19 booster, and I strongly encourage you to get it,” Walensky said.
The booster shots target both the original strain of the coronavirus and the omicron BA.4 and BA.5 subvariants that most people are catching now. This two-barreled vaccine is called a bivalent vaccine.
CDC advisors recommended that anyone age 12 and older take the new Pfizer-BioNTech boosters as authorized by the Food and Drug Administration. The updated Moderna COVID-19 vaccine is authorized for anyone 18 years of age or older.
In both cases, people should wait two months after completing the initial vaccination or the last booster vaccination. But many vaccine experts say it would be better to wait at least four months after the last infection or the COVID infection, otherwise the boosters won’t work as well.
This is the first time the FDA has authorized COVID vaccines without requiring them to be tested in humans. To keep up with the rapidly evolving virus, the FDA relied on how well the injections stimulated the mice’s immune systems. They also looked at how well similar targeted shots in earlier variants worked in people.
The companies and federal officials say there is no doubt the shots are safe, and they argue evidence shows the reformulated boosters will help reduce the chances that people will catch the virus and spread it.
But some people wonder whether it would be better to wait for results from human studies that are already underway.
“It certainly looks very promising,” said CDC advisor Dr. Pablo Sanchez of Ohio State University at Thursday’s hearing. “I understand these variants are constantly changing, but the studies with BA.4 and BA.5 are ongoing in humans and I just wonder if it’s a little premature,” he said. Sanchez was the only councilor who voted no. “I voted no because I think we really need human data,” he explained. “There is too much vaccine hesitancy already. We need human data.”
But other advisers were more comfortable, pointing out that flu vaccines are updated every year without being tested on humans.
“This is the future we are moving towards,” says Dr. Jamie Loehr of Cayuga Family Medicine. “We’re going to have more variants and we have to treat this like the flu, where we can use new variants of the strain every year.” Loehr says he’s comfortable recommending updated boosters, “even if we don’t have human data.”
Between 400 and 500 people die each day in the U.S. from COVID-19, and public health officials are concerned that another surge could hit this fall or winter. The administration hopes the reformulated boosters will help sustain an increase and protect people from serious illness or death.
The federal government plans to make the boosters available soon. Before 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.”
Now that the CDC has signed off, some photos may be available as early as Friday, with a wider rollout next week.
