On Friday, September 17, the U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee stated that booster shots of the Pfizer COVID-19 vaccine are recommended for people 65 years of age and older and for individuals who are at high risk. Last week, the FDA 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 first two doses 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.
Following the FDA announcement, the Centers for Disease Control and Prevention further clarified last Friday, 9/24, which individuals are categorized as high risk for the booster shots. CDC recommends:
- People 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 50–64 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 18–49 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.
CDC will continue to monitor the safety and effectiveness of COVID-19 vaccines to ensure appropriate recommendations. CDC will also evaluate with similar urgency available data in the coming weeks to swiftly make additional recommendations for other populations or people who got the Moderna or Johnson & Johnson vaccines. See Booster Recommendations and CDC Guidance for more information.
Only Pfizer’s vaccine has been fully approved by the FDA, for those 16 and older, and it has received emergency-use authorization for children ages 12 to 15. Moderna has emergency authorization for people 18 and older for its vaccine, and it has filed for full approval and for authorization to provide boosters. The Johnson & Johnson (J&J) vaccine is authorized for emergency use in people 18 and older and the company is planning to file for approval to provide boosters soon. J&J said last week that a second dose of its one-shot vaccine provided 100% protection against severe disease when given two months after the first inoculation.
If you have any questions, United Spinal recommends you speak with your own healthcare provider.