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HICprevent

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This award-winning blog supplements the articles in Hospital Infection Control & Prevention.

CDC Overrides ACIP Booster Vote That Left Out Healthcare Workers

September 24th, 2021

By Gary Evans, Medical Writer

In a highly unusual move, CDC Director Rochelle Walensky, MD, MPH, had to overrule her own vaccine advisory committee after they seemed to get mired in a maze of point-counterpoint and ended up not recommending COVID-19 boosters for healthcare workers by a vote of 9 to 6. The contentious meeting of the CDC Advisory Committee on Immunization Practices (ACIP) was held Sept. 23, 2021.

Walensky overruled the panel diplomatically on the occupational booster question in an email statement sent at 12:27 a.m. September 24. Clearly, the CDC could see how the vote was going to play out: Healthcare workers that held the line when there was no vaccine are now being denied the full measure of immunity amid a nursing shortage, chronic burnout, and the highly transmissible Delta variant.

Here is the recommendation as reissued and approved by Walensky:

“People aged 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.”

The other booster recommendations approved by ACIP are as follows:

  • Pople 65 years and older and residents in long-term care settings should receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series.  
  • People aged 50 to 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 aged 18 to 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.

Of all the glitches and communication errors in the pandemic response, this is one of the more surprising. Only a month or so before the ACIP vote, no less an expert than Tony Fauci, MD, was proclaiming at a White House briefing that “The booster mRNA immunization increases antibody titers by at least tenfold.” He also emphasized evidence of waning immunity of the vaccines against the SARS-CoV-2 Delta variant. Healthcare workers were among the first groups mentioned.

In any case, some of the ACIP members thought that the original occupational recommendation was too broadly written and would be difficult to explain. In fairness, Walensky’s version was more succinct, and the original language was seen by some as too open-ended. Others argued it was necessary to approve it to maintain the healthcare workforce, although it was noted that healthcare workers also — perhaps primarily — acquire COVID-19 in the community. Fauci’s promise of a multiplier effect on waning immunity never came up.

“We might as well as just say give it to everybody 18 and over,” said ACIP member Pablo Sanchez, MD, of The Ohio State University, who voted against the measure. “We have a really effective vaccine, and this is like saying it is not working — and it is working. Certainly some high-risk individuals do have waning immunity with time, but I am concerned about this.”

ACIP Chair Grace Lee, MD, MPH, of Stanford University, reminded that the benefit-risk calculation is individualized, meaning those at risk of occupational exposures and are fully vaccinated can choose to get the booster or not. The benefit is that passing the recommendation provides greater “access” to the booster, emphasized Grace, who voted in favor of the motion. The CDC reminded that the recommendation will be accompanied by education and close follow-up of myocarditis, a rare side effect seen primarily in young men.

“If an 18-year-old is anxious about myocarditis, we are not providing anything in the benefit department, but we are providing risk,” said ACIP member Sarah Long MD, of Drexel University, who voted against the measure.

The Food and Drug Administration recommendations, finalized after a Sept. 17, 2021, meeting of its vaccine advisory committee, were similar to the CDC’s with one exception. The CDC ACIP panel lowered the age range for those at high risk of severe COVID-19 to 50 years in a nod to health disparities among minorities and ethnic populations. Walensky’s statement said the agencies are in alignment, but there is much more to be done because the FDA only issued an Emergency Use Authorization for a Pfizer booster.

“ACIP only reviewed data for the Pfizer-BioNTech vaccine,” she said. “We will address, with the same sense of urgency, recommendations for the Moderna and J&J vaccines as soon as those data are available."

The FDA booster recommendations were for:

  • individuals 65 years of age and older;
  • individuals 18 through 64 years of age at high risk of severe COVID-19;
  • individuals 18 through 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.

In an initial vote, the FDA panel decided vaccine efficacy was still sufficient in immune competent people in the general population, dashing President Biden’s hopes of a large national rollout of booster shots. A lack of overall data and the concern for myocarditis side effects in young men were among the reasons cited before the 16-2 vote against broad immunization with booster doses. In comments to fellow committee members, Paul Offit, MD, vaccine expert at the Children’s Hospital of Philadelphia, summed up the situation this way.

“The stated goal of this vaccine for people like Rochelle Walensky and others has been to protect against serious illness,” he said. “The data presented shows that the vaccine still does exactly that. It is also clear, however, that the third dose of mRNA vaccine increases the titer of virus-specific neutralizing antibodies and will likely decrease the incidence of asymptomatic or symptomatic infection, which is associated with contagiousness. So then the question becomes what will be the impact of that on the arc of the pandemic? It may not be all that much. Certainly, we all agree that if we really want to impact this pandemic we need to vaccinate the unvaccinated.”