FDA Authorizes Pfizer Booster For People 65+ and Others Vulnerable to COVID-19
The U.S. Food and Drug Administration (FDA) late Wednesday authorized the use of the Pfizer booster vaccine for people who are 65 years old and older, those 18-64 years old who are at high risk of developing severe COVID-19, and people 18-64 whose occupation puts them at high risk — including healthcare workers.
“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 health care workers, teachers and day care staff, grocery workers and those in homeless shelters or prisons, among others,” said Acting FDA Commissioner Janet Woodcock, MD.
The FDA’s decision still faces a review by the Centers for Disease Control and Prevention (CDC). Once Hartford HealthCare receives CDC guidance, it will formalize plans on how the booster will be administered to those who qualify.
Keith Grant, APRN, HHC’s senior director of infection prevention, noted that the FDA’s authorization is only for the Pfizer booster. He said there is still no specific guidance on brand mixing, the practice of giving patients a different brand of booster than they received as an initial vaccine, and how soon boosters of the one-dose Johnson & Johnson vaccine will be available.
HHC teams are already planning booster clinics across the state, although no appointments are being taken yet. Dr. Ajay Kumar, HHC’s chief clinical officer, said older and immunocompromised patients have been asked at regular medical appointments if they want to be contacted when the boosters are available. Text messages have also been sent to patients.
Joseph Zuzel, manager of community health for Backus and Windham hospitals in eastern Connecticut, said now that the FDA has announced who qualifies for boosters, he is working with community partners to ensure that those who qualify for boosters get them. This includes bringing booster vaccines out into the community to those who may not otherwise seek vaccines.
Zuzel added that while boosters are the latest news, it is important to still work on reaching people who have not yet been vaccinated at all.
“We are also working hard to make sure that individuals who have not received their first round of vaccinations continue to have opportunities to do so, and have access to the facts about vaccines to help them make the decision,” Zuzel said, adding that he’s working with other community agencies to coordinate clinics.
Last month, the FDA authorized boosters for those who are immunocompromised. People qualify if they:
- Have been receiving active cancer treatment for tumors or cancers of the blood
- Received an organ transplant and are taking medicine to suppress the immune system
- Received a stem cell transplant within the last two years or are taking medicine to suppress the immune system
- Have moderate or severe primary immunodeficiency (such as DiGeorge syndrome, Wiskott-Aldrich syndrome)
- Have advanced or untreated HIV infection
- Have active treatment with high-dose corticosteroids or other drugs that may suppress their immune response.