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FDA Authorizes COVID-19 Vaccine Booster Shot for Frontline Workers

CDC endorses additional dose for employees in convenience stores, grocery stores
Photograph: Shutterstock

WASHINGTON — The U.S. Food and Drug Administration (FDA) has authorized COVID-19 booster shots for frontline grocery workers, which includes convenience-store workers. On Sept. 22, the agency amended its emergency use authorization for the Pfizer-BioNTech COVID-19 vaccine to allow for a single booster dose to be administered at least six months after the primary doses in individuals 65 and older; 18-64 year-olds at high risk of severe COVID-19; and 18-64 year-olds whose frequent institutional or occupational exposure to COVID puts them at high risk.

On Sept. 24, Centers for Disease Control and Prevention (CDC) endorsed the CDC Advisory Committee on Immunization Practices’ (ACIP) recommendation for a booster shot of the Pfizer-BioNTech COVID-19 vaccine in certain populations and also recommended a booster dose for those in high risk occupational and institutional settings.

Both the FDA and CDC recommendations are for the Pfizer vaccine only. They are still reviewing data for the Moderna and J&J vaccines.

The United States has administered approximately 387.8 million doses of COVID-19 vaccines; 212.6 million individuals (about 64%) have received at least one dose, and 182.6 million individuals (about 55%) are fully vaccinated., according to the CDC.

President Biden announced on Sept. 9 that a new federal rule will mandate COVID-19 vaccination or weekly testing for workers at private-sector companies with 100 or more employees. 

  • 78% of c-store retailers said they are requiring employees to get vaccinated, according to CSP's annual Outlook Survey. Watch for complete results in the November issue of CSP magazine.

csp outlook vaccination

“After considering the totality of the available scientific evidence and the deliberations of our advisory committee of independent, external experts, the FDA amended the [emergency use authorization] for the Pfizer-BioNTech COVID-19 vaccine to allow for a booster dose in certain populations such as healthcare workers, teachers and daycare staff, grocery workers and those in homeless shelters or prisons, among others,” Acting FDA Commissioner Janet Woodcock, M.D., said. “This pandemic is dynamic and evolving, with new data about vaccine safety and effectiveness becoming available every day. As we learn more about the safety and effectiveness of COVID-19 vaccines, including the use of a booster dose, we will continue to evaluate the rapidly changing science and keep the public informed.”

Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 vaccine has been available under emergency use authorization for individuals 16 and older. The agency expanded the authorization on May 10, 2021, to include 12-15 year-olds, and again on Aug. 12, 2021, to include the use of a third dose of a three-dose primary series in certain immunocompromised individuals 12 years and older.

The CDC recommends a Pfizer vaccine booster shot at least six months after the primary series for the following groups

  • People 65 years and older and residents in long-term care settings.
  • People aged 50–64 years with underlying medical conditions.
  • People aged 18–49 years with underlying medical conditions, based on their individual benefits and risks.
  • People aged 18-64 years who are at increased risk for COVID-19 exposure and transmission because of occupational or institutional setting, based on their individual benefits and risks.

Many of the people who are now eligible to receive a booster shot received their initial vaccine early in the vaccination program and will benefit from additional protection, the CDC said. With the Delta variant’s dominance as the circulating strain and cases of COVID-19 increasing significantly across the United States, a booster shot will help strengthen protection against severe disease in those populations who are at high-risk for exposure to COVID-19 or the complications from severe disease, the agency said.

“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,” said Director Rochelle Walensky, M.D., M.P.H. “This aligns with the FDA’s booster authorization and makes these groups eligible for a booster shot.”

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