Boosters also OK'd for frontline workers, day care providers, teachers, grocery workers.
BETH MOLE - 9/24/2021
Enlarge / CDC Director Rochelle Walensky testifies during a Senate committee hearing in July 2021.
Stefani Reynolds-Pool/Getty Images167WITH 76 POSTERS PARTICIPATING
Just past midnight last night, the director of the Centers for Disease Control and Prevention overruled a committee of independent advisers, allowing for use of a Pfizer/BioNTech vaccine booster dose in people with increased risk of occupational and institutional exposure to the pandemic coronavirus. That includes health care workers, front-line workers, teachers, day care providers, grocery store workers, and people who work or live in prisons and homeless shelters, among others.
FURTHER READINGCDC advisors OK boosters for 65+, those with health risks—not occupational risks
"As CDC Director, it is my job to recognize where our actions can have the greatest impact," Director Rochelle Walensky said in a statement. "At CDC, we are tasked with analyzing complex, often imperfect data to make concrete recommendations that optimize health. In a pandemic, even with uncertainty, we must take actions that we anticipate will do the greatest good."
She further noted that the inclusion of people at high risk of COVID-19 from occupational and institutional exposure "aligns with the FDA’s booster authorization." The Food and Drug Administration last Wednesday issued an amended Emergency Use Authorization for the Pfizer/BioNTech vaccine, which allowed booster doses for people 65 and older as well as people ages 18 to 64 who are at high risk of COVID-19 either from underlying medical conditions or occupational and institutional exposures.
Though the CDC's advisory committee was torn over endorsing that use, they ultimately decided that the need was not there—vaccine effectiveness against severe disease and hospitalization remains very strong in those under age 65. And recommending boosters for anyone with a conceivable occupational or institutional risk could create a booster free-for-all.
By taking the unusual move to overrule the ACIP's decisions, Walensky puts the booster efforts more in line with the Biden administration's preliminary plans to offer booster doses to all vaccinated adults, starting this week.
Still, the current recommendations only apply to the Pfizer/BioNTech vaccine and those who received that vaccine for their two-dose "primary series." Those who initially received two doses of the Moderna COVID-19 vaccine or one shot of Johnson & Johnson's vaccine are advised to wait for further booster data and recommendations.
For now, here are the CDC's official recommendations of who should get a Pfizer/BioNTech vaccine booster—to be given at least six months after the primary Pfizer/BioNTech series. (Emphasis added by CDC).
people ages 50–64 years with underlying medical conditions should receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series,
people ages 18–49 years with underlying medical conditions may receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series, based on their individual benefits and risks, and
people ages 18-64 years who are at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting may receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series, based on their individual benefits and risks.
Biden’s chaotic messaging on Covid-19 boosters is pitting the White House against the government’s scientific advisers
WASHINGTON — The White House’s chaotic, contradictory messaging on Covid-19 vaccine booster shots has given Americans whiplash. But more concerning, experts say, is that it risks undermining President Biden’s campaign pledge that he would listen to the scientists and adhere to official approval processes.
The administration’s latest move — a midnight Friday decision to expand booster eligibility — puts the spotlight on Rochelle Walensky, the director of the Centers for Disease Control and Prevention, who overruled her own advisory panel of scientists to make the call. Now, she finds herself caught between the White House, which had been pushing for the expanded eligibility for months, and an advisory body of experts that recommended booster shots only to a smaller part of the adult population — and that the CDC has almost never overruled.
The communications debacle comes as millions of Americans are seeking clarity about whether it’s safe to get a third shot, and whether doing so will help keep them safe from Covid. It has highlighted tensions between the White House, its scientific agencies, and their outside advisers. For many, the move was reminiscent, too, of the Trump administration’s chaotic pandemic-response communications and frequent hostility toward its own public health officia
“It’s been muddled, mixed, contradictions galore,” said Eric Topol, a physician-researcher who founded the Scripps Research Translational Institute. “It’s been checkered by political issues, rogue FDA scientists, infighting among leadership groups of the different agencies and the White House. It’s really been troubling.”
Despite the communications debacle, Topol defended the administration’s eventual decision to give most Americans access to booster shots, handed down at 1 a.m. Friday by Walensky. So, too, did an array of public health leaders, like Brown University School of Public Health Dean Ashish Jha and former CDC Director Tom Frieden.
There’s sound data for people over 60 to receive a booster, Topol said, though he criticized the White House for leaving people who received the Moderna or Johnson & Johnson vaccines in the dark — the only booster currently authorized is Pfizer’s.
Others, though, have questioned the caliber of the data being used to support giving boosters at this point. And many question whether the chaotic rollout will do more harm than good. The poll presented Thursday to the CDC’s advisory panel revealed that a third of people who are still unvaccinated say the need for a third shot would make them less likely to agree to get any doses of Covid vaccine.
One concern about the rapid rollout is that there’s little data available to support the booster shots’ safety in younger populations — particularly for men under 30, a tiny fraction of whom developed myocarditis, or heart inflammation, after receiving first or second Covid-19 doses.
“It is worrisome to me that anybody less than 30 is going to be getting a third dose without any clear evidence that that’s beneficial to them and with more than theoretical evidence that it could be harmful to them,” said Paul Offit, the director of the Vaccine Education Center at Children’s Hospital of Philadelphia.
Offit also expressed concern that in overruling the CDC’s Advisory Committee on Immunization Practices, Walensky may have damaged efforts to persuade more unvaccinated adults to be vaccinated against Covid. It’s likely, he said, that people in highly vaccinated regions, like New England, will receive a third dose while those in relatively unvaccinated regions, like the South, will remain unconvinced.
“It’s not hard to scare people who’ve already gotten two doses that they should get another dose,” he said. “I’m sure that you can get them to get 10 more doses.”
Whether or not the chaotic process will spur additional vaccine hesitancy, it has highlighted tensions and confusion between the White House, federal science agencies, and the advisory panels that exist to guide their decision-making.
The process kicked off with a shifting timeline from President Biden himself: On Aug. 18, he said Americans would be eligible for boosters eight months after their second dose. On Aug. 26, the Wall Street Journal reported that the White House was considering changing the timeline to six months. The CDC called the story “misleading” — but a day later, Biden announced that the timeline might in fact shift to five months.
Then the FDA and CDC’s scientific advisory panels weighed in.
Last week, the Vaccines and Related Biological Products Advisory Committee, a group of scientists who advise the FDA on vaccine approvals, recommended approving boosters for a dramatically smaller population than Biden first outlined: Only those over 65 and at high risk from Covid-19.
The decision was perceived as a major rebuke of the Biden administration. And it closely followed the resignations of Marion Gruber and Phil Krause, the two key FDA vaccine regulators whom Topol referred to as “rogue,” who announced their departures days after Biden’s initial booster announcement.
When the FDA authorized the booster shot, however, it brushed aside its advisers’ recommendation, adding in any American at added risk of exposure to Covid-19, like teachers, doctors, or grocery store workers.
Days later, ACIP, the CDC advisory panel, also recommended scaling back the Biden administration’s plans, recommending the shots only for the 65-plus population. But on Thursday, Walensky disregarded her own advisers, too, ruling that the younger, at-risk population could receive the shots as well.
More broadly, the administration’s disregard for the advisory boards may call into question whether the administration is “following the science,” as promised on the campaign trail.
It’s extremely rare for the CDC to buck ACIP’s recommendations on vaccination guidelines. It’s believed that a CDC director has only deviated from the committee’s guidance once before, during a 2003 controversy over how widely the George W. Bush administration should roll out to health workers and first responders a controversial smallpox vaccine that was also linked to a risk of myocarditis and pericarditis.
ACIP member Sarah Long, who voted against the recommendation that Walensky nonetheless approved, called the move “disheartening in a way.”
“I do not want to do anything now to add confusion to an already confusing situation for the public,” said Long, a professor of pediatrics at Drexel University College of Medicine. “Having said all that … I want to say that this is almost unprecedented. A surprise, would be putting it mildly.”
Grace Lee, the ACIP chair, voted for the recommendation that Walensky reinstated. She said the vote was close, Walensky had to make a decision and it is in her purview to overrule the committee.
“I respect that she has to make a call that’s difficult. And no matter what the call was that she made it would have been challenging either way. There was no winning in this situation, honestly,” said Lee, a professor of pediatrics at Stanford University School of Medicine.
In a statement, Walensky defended the decision, arguing she believed the decision would “do the greatest good” despite the lack of clear data and continued uncertainty.
Though she had clearly rejected the advice of the CDC’s vaccine advisory committee, the agency attempted to cast Walensky’s decision in a different light.
“The CDC director did not override or disregard ACIP. She agreed with the committee and added the fourth recommendation. This was her decision and she was not influenced by outsiders,” a CDC spokesperson told STAT shortly after Walensky’s statement was issued.
And while there is more recent precedent for FDA regulators defying their scientific advisers, as happened this year with the controversial approval of an Alzheimer’s drug, the administration’s actions also represent a contradiction of Biden’s longtime campaign pledge: that he would defer to “the experts.”
In a 2020 interview with STAT, Vivek Murthy, one of Biden’s top pandemic advisers and now the surgeon general, identified two key groups whose guidance should help steer vaccine approval decisions.
“The scientists that we need to hear from are the staff scientists at FDA who have been doing this for decades,” he said. He later added: “The other group we need to hear from is the external advisory committee, VRBPAC. That is a group of scientists that understands how to evaluate vaccines.”
Instead, though, the administration’s recent moves have pitted it against recommendations from VRBPAC and the ACIP, a tension that hasn’t gone unnoticed by former government officials.
“I think that staffers are scratching their heads … at both agencies,” Norman Baylor, president and CEO of Biologics Consulting and a former head of the FDA’s Office of Vaccines, told STAT.
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