The Biden administration spent Friday morning trying to clear up confusion about who should receive a Pfizer COVID-19 booster shot after days of back-and-forth debate between federal officials and their independent advisers.
Varying decisions in the multistep process leading up to permission for a third shot created puzzlement but ultimately aligns the two leading public health agencies with the White House's goal of providing boosters to the majority of Americans.
In a very rare move just before 1 a.m. on Friday, Centers for Disease Control and Prevention Director Rochelle Walensky deviated from her vaccine advisers' recommendations on who should and should not receive a third Pfizer COVID-19 shot.
She said the population receiving boosters may include adults at high risk of contracting COVID-19 due to their professions or institutional settings once they are six months past the date of their original vaccination series. Others who can get a third dose include people 65 years and older, and those who are 18 to 64 years old with underlying medical conditions.
That comes after two separate conclusions by the Food and Drug Administration and its independent advisers.
President Joe Biden celebrated the CDC's move from the White House on Friday, saying the shots could go out "this week, as planned." Biden had announced in August that COVID-19 boosters would be available for the majority of Americans around Sept. 20, even though his public health agencies had not yet cleared the shot.
But Senate Health, Education, Labor and Pensions ranking member Richard M. Burr said he was “deeply concerned" that "this process has been overshadowed by confusion created by the actions of this Administration."
The North Carolina Republican said he had asked administration officials for months about their preparations for boosters.
"The lack of a clear plan and consistent message is inexcusable," Burr said.
'More political than scientific'
Several public health experts say Walensky's decision lacked sufficient data.
"Frankly, the administration got what they wanted, which is basically anybody who wants to get this vaccine as a third dose can, because, you know, no pharmacist is going to ask you whether you work in a grocery store," said Paul Offit, a member of the FDA vaccine advisory committee that voted to provide the vaccines to a narrower portion of the population.
Emory University School of Medicine Professor Carlos del Rio agreed, noting that the CDC's final decision does not seem to be entirely based on the data at hand. An additional dose of the Pfizer COVOD-19 vaccine for individuals under age 65 does not reduce the risk of hospitalization or death, because the original vaccine series already provides ample protection against those outcomes.
"I mean, let's face it. At some point, the decision was more political than scientific, and you know, there's only so much the science can be stretched," del Rio said. "The Biden administration was trying to give boosters to everybody, and by doing so, they've gotten a little ahead of the science."
Currently, two doses of the Pfizer vaccine still count as fully vaccinated, according to administration officials. But with so many people now eligible for a third shot, healthy people who are fully vaccinated may believe they need an additional dose, even though their primary vaccination series provides ample protection.
Camille Nelson Kotton, a member of the CDC vaccine advisory committee and an infectious disease physician at Massachusetts General Hospital, said that even though Walensky overturned her vote, the decision on boosters will help reduce shortages of health care workers and teachers.
"I don't want to say, 'Oh, yes, it's totally fine that she overrode me, or overrode us.' I had trouble with the language. But this is a challenging time. There are 2,000 Americans dying each day," Kotton said.
Walensky's decision came after the CDC panel of outside vaccine advisers that includes Kotton deviated from separate recommendations by the FDA and its advisers. On Thursday, the CDC advisory panel said the Pfizer booster should be limited to seniors ages 65 and up, long-term care residents and adults 18 and up at high risk because of health problems, but not workers at high risk because of their jobs.
The week before, FDA advisers voted to recommend a third shot just for seniors 65 and older and long-term care residents. The advisers also expressed a willingness to including health care workers and other workers at high risk of exposure as part of the group that would qualify for a booster.
The committee had overwhelmingly rejected, 2-16, a plan to give additional shots to the general population, citing a lack of data.
The FDA later authorized a third shot for those 65 and older, those at high risk of developing severe COVID-19 and those at risk of developing "serious complications" due to "frequent institutional or occupational exposure," such as front-line health care workers and those in prisons.
Walensky and other top Biden administration public health officials defended their decision-making as what's best for the American people during a pandemic.
"I want to be clear that I did not overrule the advisory committees…. This was a scientific close call," Walensky told reporters Friday.
The CDC did not respond to a question about how often the CDC director overrules the advisory committee, but the move is extremely rare.
National Institute of Allergy and Infectious Diseases Director Anthony Fauci seemed to say that with the new guidelines, the purpose of the United States' COVID-19 vaccination program is to prevent any symptomatic infection, not just severe outcomes.
"There is some misunderstanding that if you don't get hospitalized, everything is okay; that is not the case," Fauci told reporters Friday. "There are many people who don't get sick enough to go to the hospital… who have a rather major disruption in their life."
Mild, symptomatic breakthrough cases are becoming increasingly common as initial vaccine immunity begins to wane and the highly contagious delta variant roars through the U.S. But nearly all of these cases, especially in healthy individuals under age 65, do not require hospitalization or supplemental oxygen.
Even though this booster push is just starting, the administration is keeping its focus on vaccinating the roughly 70 million Americans who have not yet received a shot.
"I want to be clear, we will not boost our way out of this pandemic," Walensky said.
The decision to extend Pfizer booster shots to nearly 60 million Americans, 20 million of whom are eligible as of Friday because they are six months past their second shot, precedes more activity on vaccine boosters and the expected coming authorization of COVID-19 vaccines for children who are 5 to 11 years old.
Surgeon General Vivek Murthy pledged that the Biden administration would have more data, and soon recommendations, on booster shots for Moderna and Johnson & Johnson recipients in the coming weeks.
"Your health matters just as much as other vaccine recipients," Murthy said, speaking directly to vaccinated Americans who did not receive Pfizer shots.
Emily Kopp contributed to this report.