The Centers for Disease Control and Prevention has endorsed the first updated COVID-19 booster shots.
The decision came just hours after advisers to the CDC voted to recommend reformulated versions of the Moderna and Pfizer-BioNTech COVID-19 vaccines. The vote was 13 in favor and one no vote.
"The updated COVID-19 boosters are formulated to better protect against the most recently circulating COVID-19 variant," Walensky said in a written statement announcing the recommendation.
"If you are eligible, there is no bad time to get your COVID-19 booster and I strongly encourage you to receive 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 double-barreled vaccine is called a bivalent vaccine.
The CDC advisers recommended that anyone age 12 and older get the new Pfizer-BioNTech boosters as authorized by the Food and Drug Administration. The updated Moderna COVID-19 vaccine is authorized for anyone 18 and older.
In both cases people would have to wait two months after completing their initial vaccination or their last booster shot. But many vaccine experts say it would be better to wait at least four months since the last shot or COVID infection, or the boosters won't work as well.
This is the first time the FDA has authorized COVID vaccines without requiring they get tested in people. To keep up with the rapidly evolving virus, the FDA relied on how well the shots stimulated the immune systems of mice. They also looked at how well similar shots targeted at earlier variants worked on people.
The companies and federal officials say there's no question the shots are safe and they argue the evidence indicates the reformulated boosters will help reduce the chances people will catch the virus and spread it.
But some people wonder if it would be better to wait for the results from human studies that are already underway.
"It certainly looks very promising," said CDC advisor Dr. Pablo Sanchez from The Ohio State University at Thursday's hearing. "I understand the constant shift of these variants but studies with the 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 adviser to vote no. "I voted no because I feel we really need the human data," he explained. "There's a lot of 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 in people.
"This is the future that we're heading for," says Dr. Jamie Loehr of Cayuga Family Medicine. "We're going to have more variants and we should be treating this like the flu, where we can use new strain variants every year." Loehr says he's comfortable recommending the updated boosters, "even if we don't have human data."
Committee chair, Dr. Grace Lee, professor of pediatric infectious diseases at Stanford Medicine recognized there is some uncertainty, "I want to acknowledge it," she said. "And I just want to say that despite that I think we hopefully made a huge impact in our ability to weather this pandemic together."
Between 400 and 500 people are still dying every day in the U.S. from COVID-19 and public health officials are worried another surge could hit this fall or winter. The administration hopes the reformulated boosters will help contain a surge and protect people from serious disease or death.
The federal government plans to make the boosters available quickly. In advance of the FDA's decision, Dr. Ashish Jha, the White House COVID-19 response coordinator told NPR that the new boosters represented "a really important moment in this pandemic."
Now the CDC has signed off, few shots could be available as early as Friday, with a wider rollout next week.
AILSA CHANG, HOST:
CDC Director Rochelle Walensky has signed off on the first updated versions of the COVID-19 vaccines. Earlier today, advisers to the Centers for Disease Control and Prevention endorsed the updated boosters with only one person voting no. Now, this is a crucial step towards making the new shots available starting later this week.
NPR health correspondent Rob Stein joins us now. Hey, Rob.
ROB STEIN, BYLINE: Hey, Ailsa.
CHANG: Hey. OK. So the Food and Drug Administration authorized the new boosters just yesterday. Who did the CDC advisers say should get them?
STEIN: Yeah. So just to remind everyone, the boosters are new versions of the Moderna and Pfizer-BioNTech vaccines that have been reformulated to protect people against the original strain of the virus and, for the first time, the omicron subvariants known as BA.4 and 5. That's what most people are catching these days. The CDC advisers endorse the new Pfizer-BioNTech booster for anyone 12 and older and the Moderna vaccine for anyone 18 or older. People would have to wait at least two months after their last shot. But some experts say people should really wait at least four months since their last shot or the last infection or the new shots just won't work very well.
CHANG: OK. And explain again, why are the new boosters being recommended?
STEIN: You know, it may feel like the pandemic's kind of ending, but hundreds of people are still dying every day. And yet another surge could hit this fall and winter, when lots of people are vulnerable because the immunity they got from their shots or infections has faded. Officials hope the new boosters will protect people better so life can continue to return to normal.
CHANG: But how well do the new boosters work? Do we know?
STEIN: Yeah, Ailsa, that's the big question. For the first time, the FDA authorized these vaccines without requiring that they get tested in people. To try to keep up with the rapidly evolving virus, the FDA relied on how well the shots stimulated the immune systems of mice and how shots targeted at earlier variants looked like they worked in people. No one doubts the shots are safe, and federal officials say they're confident the new omicron boosters will cut the chances people will catch the virus, spread it and end up with COVID or long COVID. The shots may also provide longer-lasting protection and even possibly immunity against new variants.
CHANG: Wow. OK. So all of that sounds promising, but without testing in humans, I imagine not everyone is fully on board.
STEIN: Yeah, that's right. That's right. Some experts are clearly uneasy about this. Let's listen to Dr. Pablo Sanchez from Ohio State University. He was the only adviser who voted against the boosters.
(SOUNDBITE OF ARCHIVED RECORDING)
PABLO SANCHEZ: I'm just, you know, struggling with a recommendation. I understand that we need better vaccines, but to make a recommendation for a vaccine that has not been studied in humans, I'm just very - I just want to bring that up as a concern.
STEIN: But, you know, bear in mind, the flu vaccine is updated every year without testing them in people. And in the end, a majority of the advisers decided they were comfortable with starting to treat the COVID vaccines more like flu vaccines. Here's Dr. Jamie Loehr of Cayuga Family Medicine.
(SOUNDBITE OF ARCHIVED RECORDING)
JAMIE LOEHR: This is the future that we're heading for, which is we're going to have more variants. And we should be treating this like the flu, where we can use new strain variants every year. So after thinking about it, I am comfortable. Even though we don't have human data and just animal data, I'm supporting the BA.4/5 variants booster.
CHANG: Well, I'm on board. When can people start getting these shots?
STEIN: You know, the shots could start to become available on a very limited basis starting as soon as tomorrow and then really start to become widely available next week.
CHANG: That is NPR health correspondent Rob Stein. Thank you, Rob.
STEIN: Sure thing, Ailsa. Transcript provided by NPR, Copyright NPR.