The U.S. Food and Drug Administration on Friday amended the emergency use authorizations for both the Pfizer-BioNTech and Moderna COVID-19 vaccines, authorizing use of a single booster dose for everyone aged 18 or more years after they have completed primary vaccination with any FDA-authorized or approved COVID-19 vaccine.
The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet later today to discuss further clinical recommendations.
“COVID-19 vaccines have proven to be the best and highly effective defense against COVID-19. Authorizing the use of a single booster dose of either the Moderna or Pfizer-BioNTech COVID-19 vaccine for individuals 18 years of age and older helps to provide continued protection against COVID-19, including the serious consequences that can occur, such as hospitalization and death,” Acting FDA Commissioner Janet Woodcock, M.D., said in a statement.
Before today’s authorizations from the FDA, a single booster dose of the Pfizer-BioNTech or Moderna COVID-19 vaccines was authorized only for adults aged 65 or more years, those aged 18 to 64 at high risk of severe COVID-19, and those aged 18 to 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2, such as workers in senior living communities.
Today’s action by the FDA expands the use of booster doses to all adults at least six months after they have have received the second of two initial doses of the Moderna COVID-19 Vaccine or Pfizer-BioNTech COVID-19 vaccine, or at least two months after they have received the initial dose of the Janssen (Johnson & Johnson) COVID-19 vaccine.
“Streamlining the eligibility criteria and making booster doses available to all individuals 18 years of age and older will also help to eliminate confusion about who may receive a booster dose and ensure booster doses are available to all who may need one,” Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said in a statement.
This is a developing story. This website will have additional information as it becomes available.