FDA Authorizes Pfizer/BioNTech COVID-19 Vaccine Booster - What’s Next?

The FDA amended the Emergency Use Authorization (EUA) for the Pfizer vaccination to allow the use of a single booster dose only to those who received the Pfizer vaccine and 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
  • 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. 
Individuals in these groups who were vaccinated with the Moderna or Janssen (Johnson & Johnson) vaccine are not recommended to receive a booster shot at this time. The CDC and FDA will be reviewing data on these vaccines to determine the need for a booster shot in the coming weeks. 
The CDC recommends the following groups receive a booster shot of the Pfizer-BioNTech's COVID-19 vaccine at least six months after their primary series:  
  • People 65 years and older 
  • Residents in long-term care settings  
  • People aged 50–64 years with underlying medical conditions  
  • People aged 18–49 years with underlying medical conditions may receive a booster shot 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 (e.g., health care workers) may receive a booster shot based on their individual benefits and risks  
While the FDA and CDC recommendations differ slightly, the two agencies agree that long term care residents and staff who completed their Pfizer primary series at least six months ago should receive a booster dose. 
The Federal CDC has created a webpage to help long term care providers access the booster dose. Providers should work with their long term care pharmacies to gain access to the booster dose.  
MHCA recently met with representatives of Maine CDC to plan for booster shot rollout in Maine's long term care facilities. MHCA thanks members for completing the Association's survey, as well as the State's version. MHCA recommends that you contact your pharmacy representative as soon as possible to schedule booster shots for residents who had Pfizer, as well as any staff who may want the booster if six months have passed since primary dose. Please note – the third shot is not included in the Maine CDC definition of “fully vaccinated” for the purpose of the state health care worker mandate. 
Given the frailty of our long term care population and the storage requirements of the Pfizer vaccine, in-house clinics provided by pharmacies are preferable, but members should discuss the options with their pharmacy providers. If your pharmacy is unable to provide a clinic, please contact Nadine Grosso at MHCA, or 207-623-1146 so we may work with CDC on options. 
As a reminder, the CDC and ACIP have noted that the COVID-19 vaccine and the influenza vaccination can be co-administered in cases where an individual is eligible for both vaccinations.  
Please visit AHCA's #GetVaccinated for resources on increasing vaccine confidence.