The head of the Centers for Disease Control and Prevention on Friday overruled an advisory panel by approving the distribution of Pfizer and BioNTech’s Covid-19 booster vaccinations to a wide variety of workers in the United States
CDC director Dr. Rochelle Walensky signed a number of the panel’s recommendations, including distributing the recordings to older Americans and adults with underlying medical conditions at least six months after their first series of recordings. But she broke off the panel by also releasing boosters to those in high-risk professional and institutional settings in an unusual decision that is likely to fuel protests from anti-vaccine advocates.
“As CDC director, it’s my job to identify where our actions can have the greatest impact,” Walensky said in a statement. “At CDC, our job is to analyze complex, often imperfect data in order to make specific recommendations for optimizing health. In a pandemic, even when there is uncertainty, we must take measures that we expect will be most useful.”
The highly unusual move coincides with the FDA approving the shots earlier this week, she noted.
Approximately 60 million of the 100 million Americans who originally received the Pfizer BioNTech Covid vaccine are now eligible for a third vaccination as the highly contagious Delta variant continues to occur across the country, including health care workers, teachers, staff of grocery stores and other indispensable workers.
“The majority of Americans fully vaccinated with the Pfizer vaccine can now get the booster six months after the second vaccination,” President Joe Biden told the nation Friday.
Hours earlier, the Agency’s Advisory Committee on Vaccination Practices endorsed the administration of Pfizer third vaccinations to people 65 and older, nursing home residents, and those ages 18 to 64 with pre-existing conditions such as pregnancy, HIV, cancer, diabetes, obesity, or heart disease.
However, Walensky overturned a decision that was rejected by the panel on Thursday evening. The panel voted 9 to 6 against giving booster shots to adults at higher risk of exposure to the virus due to their workplace or institutional setting.
While the FDA and CDC only reviewed the data for the Pfizer vaccine, Walensky said they would implement recommendations for Moderna and Johnson & Johnson boosters “with the same urgency” as soon as those data became available. Moderna submitted its booster application on Sept. 1, and J&J announced Wednesday that it had also submitted its data showing that an extra dose of its vaccine increases protection against infection by 94%. The FDA, which is reviewing these applications before the CDC, has not yet announced when it will review the data.
“My message to you is: you still have a high level of protection,” Biden told recipients of these two vaccines. He said regulators are working “day and night” to analyze this data.
The director of the National Institutes of Health, Dr. Francis Collins said Thursday that a decision on the third dose of Moderna and J&J could be made within weeks. He added that the NIH is currently conducting a study to determine the effects of mixing primary vaccine doses from one manufacturer with boosters from another manufacturer.
Here’s what the CDC recommends:
- People aged 65 and over and residents in long-term care facilities should receive a booster dose of the Covid vaccine from Pfizer-BioNTech at least six months after the Pfizer BioNTech Primary Series;
- People between 50 and 64 years of age with previous illnesses should receive a booster shot from Pfizer-BioNTech at at least six months after their Pfizer BioNTech primary series;
- People between 18 and 49 years of age with previous illnesses can Receive a booster dose of the Pfizer BioNTech vaccine for at least six months after the Pfizer BioNTech Primary Series, based on individual benefit and risk;
- Individuals between the ages of 18 and 64 who are at increased risk of exposure and transmission of Covid-19 due to their professional or institutional environment can Receive a booster dose of the Pfizer BioNTech vaccine for at least six months after the Pfizer BioNTech Primary Series, based on their individual benefits and risks.
“I believe that we can best meet the country’s public health needs by providing booster doses to the elderly, those in long-term care facilities, those with underlying medical conditions, and adults at high risk of illness from occupational and institutional exposure to COVID. 19 “, she said.
Earlier Thursday, the CDC Advisory Board grappled with the controversial proposal to give a boost to a broad segment of the US population. By breaking off the panel, Walensky paved the way for the shots to be distributed to nursing home staff, people who live or work in prisons and homeless shelters, frontline health workers, unpaid caregivers, teachers, and other key employees.
“I mean, we might as well say give it to anyone over the age of 18,” said committee member Dr. Pablo Sanchez before voting against the proposal.
Lisa Wilson receives a syringe of the Pfizer vaccine at a mobile COVID-19 vaccination center in Orlando, Florida.
Paul Hennessy | SOPA pictures | LightRakete | Getty Images
Dr. Leana Wen, an emergency doctor and former Baltimore health commissioner, called the CDC panel’s vote to reject boosters more generally a “mistake.”
“Really, are we not allowing health workers, many of whom were vaccinated back in December, to be boostered? What about teachers in cramped classrooms that don’t require masks? ”She tweeted, adding that CDC Director Dr. Walensky should override the recommendation.
At a Covid press conference in the White House on Friday afternoon, Walensky insisted that she not “overrule” the committee.
“This was a scientific scarcity,” said Walensky, noting the lengthy two-day meeting and robust debate. “In that situation, it was my appeal. If I had been in the room, I would have voted yes … after listening to all of your scientific reasoning.”
She tried to build public confidence by encouraging people to go back and listen to the committee’s discussion. “We made it public, we made it transparent, and we did it with some of the best scientists in the country,” she added.
The CDC’s final decision allows Biden to claim victory despite not getting everything he wanted. The government said it plans to start giving booster shots to people aged 16 and over this week. While the CDC panel’s recommendation doesn’t give the Biden administration everything it wanted, boosters will still be around for millions of Americans who originally received Pfizer’s shots.
On Wednesday, the Food and Drug Administration gave many Americans emergency clearance to give third Pfizer shots six months after completing the first two doses. While the CDC committee’s recommendation is not binding, Walensky was expected to accept the panel’s approval.
Walensky addressed the committee on Thursday ahead of the vote, thanking them for their work and setting out what is at stake.
“These dates are not perfect, but together they paint a picture for us, and they are what we have right now to make a decision about the next phase of this pandemic,” she said.
Before the vote, some committee members expressed concern that the wide range of boosters on offer could affect efforts to get unvaccinated vaccines or reduce confidence in the vaccines’ effectiveness. Others were frustrated that only Pfizer recipients were eligible to receive the vaccinations, leaving out millions of Americans who received the Moderna and Johnson & Johnson vaccines.
The vote came at the end of a two-day meeting during which CDC advisors listened to several presentations of data to support the widespread adoption of booster vaccinations, including one from a Pfizer executive showing data showing a third Injection appears to be safe and increases antibody levels in recipients.
During a presentation on Thursday, CDC officer Dr. Sara Oliver observational studies from Israel in which officials in front of many other countries began vaccinating the country’s population and offering third vaccinations to their citizens in late July.
The Israeli data has been criticized by at least one FDA official for being based on so-called observational studies, which do not meet the same standards as formal clinical studies.
“We can use Israel’s experience to reinforce our knowledge of booster safety,” Oliver said, adding that the country reported only one case of a rare heart infection known as myocarditis out of nearly 3 million third doses administered .
