Recommendation follows less than 24 hours after FDA authorization

At a contentious meeting, the CDC’s Advisory Committee on Immunization Practices voted to recommend booster doses of Pfizer-BioNTech’s Covid-19 vaccine (BNT162b2/Comirnaty) for individuals ages ≥65 years, individuals 50-64 years of age with underlying medical conditions, and individuals 18-49 years of age with underlying medical conditions based on individual benefit and risk assessment.

The committee voted on a total of four possible interim recommendations—the votes played out as follows:

  • “A single Pfizer-BioNTech Covid-19 vaccine booster dose is recommended for persons ≥65 years, and [long-term care facility] residents, at least 6 months after the primary series under the FDA’s Emergency Use Authorization.” All 15 ACIP members voted “yes” on this recommendation.
  • “A single Pfizer-BioNTech Covid-19 vaccine booster dose is recommended for persons aged 50-64 years with underlying medical conditions at least 6 months after the primary series under the FDA’s Emergency Use Authorization.” ACIP voted “yes” on this recommendation, with 13 for and 2 against.
  • “A single Pfizer-BioNTech Covid-19 vaccine booster dose is recommended for persons based on individual benefit and risk who are aged 18-49 years with underlying medical conditions, at least 6 months after the primary series under the FDA’s Emergency Use Authorization.” ACIP voted “yes” on this recommendation, with 9 for and 6 against.
  • “A single Pfizer-BioNTech Covid-19 vaccine booster dose is recommended based on individual benefit and risk for persons 18-64 years who are in an occupational or institutional setting where the burden of Covid-19 infection and risk of transmission are high, at least 6 months after the primary series under the FDA’s Emergency Use Authorization.” ACIP voted “no” on this recommendation, with 6 for and 9 against.

For those who voted “no,” the sticking point was a lack of evidence—the data presented at the 2-day ACIP meeting did not demonstrate waning immunity among younger individuals with underlying conditions or those with increased occupational/institutional exposure who have already received a full series of the Pfizer-BioNTech vaccine. In other words, there is a concern that these populations may not gain much benefit but may face additional risk—for example, vaccine-associated myocarditis, which thus far appears more common among younger recipients of the mRNA vaccines.

Sarah S. Long, MD, of Drexel University College of Medicine and St. Christopher’s Hospital for Children in Philadelphia, argued that the fourth recommendation in particular was too open-ended. “It seems uncharacteristically open-ended for the lack of data of need in any of these groups,” she said.

On the other hand, Camille Nelson Kotton, MD, FIDSA, FAST, of Massachusetts General Hospital and Harvard Medical School argued that by immunizing those at risk for exposure through work or their institution, those who are immunocompromised will gain greater second-hand protection.

“Everything that everyone said thus far has been basically true,” Oliver Brooks, MD, FAAP, chief medical officer at Watts HealthCare Corporation, added. “…And it’s a difficult decision, but that’s where we are right now in this pandemic.”

The recommendation follows less than one day after the FDA amended the emergency use authorization (EUA) for the Pfizer-BioNTech vaccine to allow for single-shot booster doses at least 6 months after full vaccination in:

  • “Individuals 65 years of age and older.
  • “Individuals 18-64 years of age at high risk of severe Covid-19.
  • “Individuals 18-64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of Covid-19 including severe Covid-19.”

“After considering the totality of the available scientific evidence and the deliberations of our advisory committee of independent, external experts, the FDA amended the EUA for the Pfizer-BioNTech Covid-19 Vaccine to allow for a booster dose in certain populations such as health care workers, teachers and day care staff, grocery workers and those in homeless shelters or prisons, among others,” acting FDA Commissioner Janet Woodcock, MD, said in a statement.

Which Populations Are The Priority?

In discussing the booster vote, Helen Keipp Talbot, MD, associate professor of medicine at Vanderbilt University in Nashville, voiced skepticism over whether authorizing boosters for people who have already been vaccinated will move the needle on the Covid-19 pandemic.

“We’re fighting a pandemic, and that’s not because people got the vaccine,” she said. “It’s because people are unvaccinated… The hospitals are full because people aren’t vaccinated. We are declining care to people who deserve care because we are full of unvaccinated, Covid-positive patients… So, in all honesty, you know, we could give boosters to people but that’s not really the answer to this pandemic.”

Lynn Bahta, RN, MPH, CPH, of the Infectious Disease, Epidemiology, Prevention & Control Division of the Minnesota Department of Health in Saint Paul, Minnesota, mimicked Talbot’s concern, noting that “those who were vaccinated felt like that was the magic bullet, and so many abandoned the other mitigation measures because we heard that it was okay to do so. And now we’re in a situation where the unvaccinated, of course, are becoming very, very ill, but [on top of that] the vaccinated are getting sick. And that, again, reduces the confidence that people have in the vaccine.

Talbot and Bahta’s concerns echo a common opinion at this stage in the pandemic—President Biden recently called Covid-19 “a pandemic of the unvaccinated,” and a substantial swath of the general population believes that the unvaccinated should pay higher insurance premiums, according to results from a 600-person survey published by

Another concern raised during the discussion was that by prioritizing these individuals for boosters, the CDC might inadvertently shift prioritization away from vaccinating those who have yet to get the shot.

On the other hand, Sandra Adamson Fryhofer, MD, a liason representative from the American Medical Association and adjunct associate professor of medicine at Emory University School of Medicine in Atlanta, argued that refusal to allow for flexibility to give boosters to these groups may deprive patients of a life-saving shot.

“I understand the need, you know, for making public health decisions, but this is the vaccine that has been paid for by the government with our tax dollars, and there are patients out there whose vaccine effectiveness is decreasing, who have multiple medical problems that if they get [Covid], they are very likely going to be the ones that die… We can’t make someone wear a mask, we can’t control everything that happens, and I think making vaccine available to those that want to get a booster is a way of supporting the people that have chosen to be fully vaccinated.”

Limiting Covid-19 vaccine boosters to these populations offset the Biden administration’s hopes of rolling out boosters to all vaccinated individuals in the U.S. starting this month. But the administration is still making moves to combat the pandemic, with President Biden announcing at the Virtual Global Covid-19 Summit on Wednesday that the U.S. is commiting to donate a further 500 million doses of the Pfizer vaccine to low- and middle-income countries.

This commitment will bring the total number of donated Covid-19 vaccines from the U.S. to over 1.1 billion, or three doses for every one dose administered in the U.S., Biden noted. The administration also plans on donating $370 million to support the administration and delivery of these vaccines, and over $380 million to the Global Vaccine Alliance to facilitate vaccine distribution in underserved areas.

John McKenna, Associate Editor, BreakingMED™

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