Pharmacists Grapple With Mixed Public Health Messages on COVID-19 Boosters

Should people in high-risk occupational and institutional settings be prioritized by COVID-19 booster shots, despite age? A CDC advisory panel said no, but it was overruled by the agency’s director. Now, public health officials say 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. Here is more information.

ATLANTA - Going against an influential advisory committee, Rochelle P. Walensky, MD, MPH, director of the national Centers for Disease Control and Prevention, recommended a booster COVID-19 vaccine dose for those in high-risk occupational and institutional settings.

Walensky also endorsed the CDC’s Advisory Committee on Immunization Practices’ (ACIP) recommendation for a booster shot of the Pfizer-BioNTech COVID-19 vaccine in older populations, including some who are younger than 65 but have high-risk medical conditions, not occupations.

The on-again, off-again actions sowed confusion among pharmacists and other vaccine providers.

“I believe we can best serve the nation’s public health needs by providing booster doses for the elderly, those in long-term care facilities, people with underlying medical conditions, and for adults at high risk of disease from occupational and institutional exposures to COVID-19,” the CDC director said in a press release. “This aligns with the FDA’s booster authorization and makes these groups eligible for a booster shot. Today, ACIP only reviewed data for the Pfizer-BioNTech vaccine. We will address, with the same sense of urgency, recommendations for the Moderna and J&J vaccines as soon as those data are available.”

ACIP had voted unanimously to recommend a booster dose of Pfizer's COVID-19 vaccine, marketed as Comirnaty, only for adults 65 and older, as well as for those in long-term care facilities. For younger adults – those 50 to 64 -- with high-risk medical conditions, the panel voted 13-2 to recommend boosters for them. 

On the other handed, ACIP voted 9-6 against recommending that adults 18 to 49 with high-risk medical conditions should get booster doses of COVID-19 vaccine, taking into account individual risk. It also opposed by a 6-9 vote an interim recommendation for booster shots for adults ages 18 to 64 who were at high risk of occupational or institutional exposure to COVID-19, based on their individual benefit and risk.

The issue for those opposed fell into two categories: Those who said there was no scientific evidence that profession made individuals more likely to have severe COVID-19, and others who caution that mass confusion might result from a system in which people would judge individual risk and benefit not based on clinical factors.

High-risk medical conditions include cancer; chronic kidney disease; chronic lung diseases dementia or other neurological conditions; type 1 or type 2 diabetes; Down syndrome; heart conditions; HIV infection; immunocompromised state; liver disease; overweight or obesity; pregnancy; sickle cell disease or thalassemia; a smoking habit or former smoking habit; solid organ or blood stem cell transplant; stroke or cerebrovascular disease and substance use disorders

CDC recommends the following:

  • people 65 years and older and residents in long-term care settings shouldreceive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine at least 6 months after their Pfizer-BioNTech primary series,
  • people aged 50–64 years with underlying medical conditions should receive a booster shot of Pfizer-BioNTech’s COVID-19 vaccine atleast 6 months after their Pfizer-BioNTech primary series,
  • people aged 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 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 actions by Walensky and ACIP came after the Food & Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to allow for use of a single booster dose, to be administered at least six months after completion of the primary series in:

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

https://www.fda.gov/news-events/press-announcements/fda-authorizes-booster-dose-pfizer-biontech-covid-19-vaccine-certain-populations

“As CDC Director, it is my job to recognize where our actions can have the greatest impact,” she said. “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.”

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