The U.S. drug regulator, the Food and Drug Administration (FDA) has given its authorization for fully vaccinated Americans who are age 18 and older to receive a COVID-19 booster shot.
The U.S. Food and Drug Administration on Friday 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.
The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices will meet later today to discuss further clinical recommendations, the FDA said.
If the panel approves and CDC endorses, the booster shots could become widely available right away.
“The FDA has determined that the currently available data support expanding the eligibility of a single booster dose of the Moderna and Pfizer-BioNTech COVID-19 vaccines to individuals 18 years of age and older,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “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.”
People who got the Pfizer or Moderna immunizations to start would be eligible for a booster six months after their second shot, the FDA said. People who got the Johnson & Johnson vaccine would be eligible for a booster two months after their first shot.
For the Moderna COVID-19 Vaccine booster dose, the FDA analyzed the immune response data from 149 participants 18 years of age and older from the original clinical studies who received a booster dose at least six months after their second dose and compared it to the immune responses of 1,055 study participants after completing their two-dose series. The antibody response against the SARS-CoV-2 virus 29 days after a booster dose of the vaccine demonstrated a booster response.
For the Pfizer-BioNTech COVID-19 Vaccine booster dose, the FDA analyzed the immune response data from approximately 200 participants 18 through 55 years of age who received a single booster dose about six months after their second dose. The antibody response against the SARS-CoV-2 virus one month after a booster dose of the vaccine when compared to the response one month after the two-dose primary series in the same individuals demonstrated a booster response.
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