On Nov. 19, the U.S. Food and Drug Administration amended the emergency use authorizations (EUA) for both the Moderna and Pfizer-BioNTech COVID-19 vaccines authorizing use of a single booster dose for all individuals 18 years of age and older after completion of primary vaccination with any FDA-authorized or approved COVID-19 vaccine.
Later that same day, the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices met to discuss further clinical recommendations, and ultimately approved the decision.
A press release from the FDA states that “Prior to today’s authorizations, a single booster dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines was authorized for administration to 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 with frequent institutional or occupational exposure to SARS-CoV-2. Today’s action expands the use of booster doses of both vaccines to include all individuals 18 years of age and older at least six months after completion of the primary vaccination series of the Moderna COVID-19 Vaccine or Pfizer-BioNTech COVID-19 Vaccine or at least two months after completion of primary vaccination with the Janssen COVID-19 Vaccine.”
Further, “Since Moderna and Pfizer-BioNTech initially submitted safety and effectiveness data on a single booster dose following primary vaccination to the FDA, additional real-world data have become available on the recently increasing number of cases of COVID-19 in the U.S. and on the risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the outer lining of the heart) following vaccination with these vaccines. These additional data enabled the FDA to reassess the benefits and risks of the use of these vaccines in the general adult population. The FDA has determined that the benefits of a single booster dose of either the Moderna or Pfizer-BioNTech COVID-19 vaccines outweigh the risks of myocarditis and pericarditis in individuals 18 years of age and older when used following completion of primary vaccination to provide continued protection against COVID-19 and the associated serious consequences that can occur including hospitalization and death.”
Acting FDA Commissioner Janet Woodcock, M.D. was quoted in the release saying that “Throughout the course of the COVID-19 pandemic, the FDA has worked to make timely public health decisions as the pandemic evolves. 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.”
Additionally, Daniel P. McQuillen, M.D., president of the Arlington, Va.-based Infectious Diseases Society of America made a statement in a news release on the expansion. “The Infectious Diseases Society of America supports the FDA and CDC decision to expand eligibility for COVID-19 vaccine boosters to include everyone age 18 and older,” said McQuillen.
“Data show that a booster shot provides highly effective continued protection against breakthrough COVID-19 infections, serious illness, hospitalization and death,” he continued. “Everyone 18 and older who received a two-dose mRNA vaccine should get their booster shots six months after they completed the series to maximize protection against COVID-19.”
