CDC backs Pfizer COVID-19 vaccine booster shots for millions of seniors and others at risk
Many recipients of Pfizer's COVID-19 vaccine can now receive booster shots, the Centers for Disease Control and Prevention announced Friday, clearing the final hurdle for third doses to be rolled out nationwide this week.
CDC Director Rochelle Walensky signed off on recommendations that a panel of the agency's outside vaccine advisers voted to endorse Thursday, saying that three groups "should" receive booster shots six months after their second dose: seniors 65 and over, nursing home residents, and adults at least 50 years old with "underlying medical conditions."
The CDC also issued guidance for other adult Pfizer recipients, saying that those with underlying medical conditions or those who were "at increased risk" for COVID-19 exposure because of where they lived or worked, like health care providers and prisoners, "may" choose to receive a third dose. Occupations that may carry a higher risk of exposure also include teachers, grocery store workers and others, officials said.
Americans will be able to receive the boosters if they "self-attest" that they are eligible, the CDC said.
"As CDC director, it's my job to recognize where actions can have the greatest impact. In a pandemic, we most often take steps with the intention to do the greatest good, even in an uncertain environment. And that is what I'm doing with these recommendations," Walensky said at a White House briefing on Friday.
Federal health officials said the government and medical providers have been scaling up to prepare for a wave of demand for the booster shots, which will be available at tens of thousands of pharmacies and other locations nationwide.
"As of today, up to 20 million Americans can get their booster. We are ready to get booster shots in arms right away," Jeff Zients, head of the White House's COVID-19 response, told reporters at the briefing.
He added that the booster shots are free, with no I.D. or insurance required.
Disagreement with the advisory committee
The sweeping recommendations come after the Food and Drug Administration granted a similar emergency use authorization for Pfizer's booster shot, and the CDC's Advisory Committee on Immunization Practices met for two days to deliberate over the third doses.
However, in a rare break with the committee, the CDC director on Friday rejected one of their decisions. A majority of the ACIP's members had actually voted on Thursday evening against recommending use of the shots in adults "who are in an occupational or institutional setting where the burden of COVID-19 infection and risk of transmission are high."
Some members of the ACIP had voiced concern that the move could drain resources and attention from the push to reach unvaccinated Americans to get their shots. They also considered polling data showing a third of unvaccinated Americans said they would be "less likely" to get vaccinated if booster shots were recommended.
Others worried that current data suggested most younger adults would gain little benefit over the already high protection offered from the first two shots against severe disease, while exposing them to potential risks. For example, CDC modeling presented to the committee suggested that the benefits of a booster dose in young men might not "clearly outweigh the risks" of heart inflammation associated with the vaccine, if COVID-19 cases declined.
"I understand the people who say these people who got vaccinated earlier have been our people on the front lines, and we don't want to abandon them. But it doesn't do justice to the data that says whether they need it," said Dr. Sarah Long, a professor at Drexel University and one of the ACIP members to vote against the recommendation. Nine of the panel's members had voted against the recommendation, versus six in favor.
Long said she was "disappointed" and "shocked" with the CDC director for not siding with the ACIP's vote, which has happened rarely in the history of the committee. Long believes the decision will complicate future discussions over booster doses.
"How am I going to make the next decision already knowing that everybody who got Pfizer is getting boosters? Can we have the same approach based on the science for the majority of people, if we think they are not going to need this," said Long.
On Friday, Walensky told reporters she "did not overrule an advisory committee," and had incorporated the committee's days-long discussions into her decision.
"I think you could tell by the duration of the meeting and the discussions that this was a scientific close call. In that situation, it was my call to make. If I had been in the room, I would have voted yes," said Walensky.
Dr. Katherine Poehling, a professor at Wake Forest School of Medicine and ACIP member who had voted against it, said she appreciated that Walensky "understood and saw how the committee was grappling" with the issue.
"If you look at what the CDC director's decision said, she added a critically important word, 'may,' which clearly defines choice," said Poehling.
What about Moderna and Johnson & Johnson boosters?
Several members of the committee, including local and state health officials, also voiced concern that broader recommendations for Pfizer's booster shots would be difficult to implement -- especially without similar permission for doses of Moderna and Johnson & Johnson's vaccine.
Regulators are still reviewing a submission by Moderna, which sought permission last week for booster shots of its vaccine at 50 micrograms — half the dose of its first two shots. Johnson & Johnson has yet to announce an application for approval of a second dose for its vaccine, though federal health officials say they expect the submission soon.
Meanwhile, research backed by the National Institutes of Health examining the safety and efficacy of so-called "mix-and-match" boosting has yet to release results.
Regardless, federal health officials said the initial series of doses — two for Pfizer and Moderna, or one from Johnson & Johnson's Janssen vaccine — would still be sufficient everyone to be considered "fully vaccinated."
"FDA is working closely with Moderna and J&J to get and process their data as quickly as possible, with a goal of making booster recommendations for Moderna and J&J recipients in the coming weeks," Surgeon General Vivek Murthy told reporters on Friday.
"This is a high, high priority."