For immediate release:

Spanish

Today, the United States Food and Drug Administration amended the Emergency Use Authorizations (EUA) for Moderna and Pfizer-BioNTech COVID-19 vaccines to allow the use of a single booster dose for all people 18 years of age and older after completing the primary series with any COVID-19 vaccine authorized or approved by the FDA. The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices will meet later today to discuss other clinical recommendations.

“Throughout the COVID-19 pandemic, the FDA has strived to make timely public health decisions as the pandemic evolves. COVID-19 vaccines have proven to be the best and most effective defense against COVID-19. Allowing the use of a single booster dose of the Moderna or Pfizer-BioNTech COVID-19 vaccine for people 18 years of age and older helps ensure continued protection against COVID-19, including the serious consequences that may occur, such as hospitalization and death, ”said Acting FDA Commissioner Janet Woodcock, MD

Prior to today’s clearances, a single booster dose of Moderna and Pfizer-BioNTech COVID-19 vaccines was allowed for administration to people 65 years of age and older, people 18 to 64 years of age at high risk of COVID -19 severe and people 18 to 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 people 18 years of age and older at least six months after the end of the Moderna COVID-19 vaccine primary vaccination series or of the Pfizer-BioNTech COVID-19 vaccine or at least two months after the end of the primary vaccination with the Janssen COVID-19 vaccine.

“The FDA has determined that currently available data supports expanding the eligibility of a single booster dose of Moderna and Pfizer-BioNTech COVID-19 vaccines to people 18 years of age and older,” said Peter Marks, MD, Ph.D., Director of the Center for Biologics Evaluation and Research, FDA. “Streamlining the eligibility criteria and making booster doses available to all people 18 years of age and over will also help eliminate confusion over who can receive a booster dose and ensure that doses of reminder are available for anyone who might need it. “

Effectiveness in supporting data

The EUA for a single booster dose for people 18 years of age and over for Moderna (administered as half the dose of a primary serial dose) and Pfizer-BioNTech COVID-19 vaccines is based on the analysis FDA immune response data that sustained use in populations previously cleared for boosters.

For the Moderna COVID-19 vaccine booster dose, the FDA analyzed immune response data from 149 participants aged 18 and older from original clinical studies who received a booster dose at least six months after their second dose. and compared it to the immune system. responses from 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 booster dose of the Pfizer-BioNTech COVID-19 vaccine, the FDA analyzed immune response data from approximately 200 participants aged 18 to 55 who received a single booster dose approximately six months after their second dose. The antibody response against the SARS-CoV-2 virus one month after a booster dose of the vaccine compared to the response one month after the primary two-dose series in the same individuals demonstrated a booster response.

FDA Assessment of Benefits and Risks

Since Moderna and Pfizer-BioNTech initially submitted data to the FDA on the safety and efficacy of a single booster dose after the primary series, additional actual data has become available on the recently increasing number of COVID cases. -19 in the United States and on the risk. myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the outer wall of the heart) following vaccination with these vaccines. These additional data allowed the FDA to re-evaluate the benefits and risks of using these vaccines in the general adult population. The FDA has determined that the benefits of a single booster dose of Moderna or Pfizer-BioNTech COVID-19 vaccines outweigh the risks of myocarditis and pericarditis in people 18 years of age and older when used after completion of the primary vaccination course to ensure continued protection against COVID-19 and the associated serious consequences that may occur, including hospitalization and death.

Pfizer and Moderna are both conducting post-authorization / post-marketing studies to assess the known serious risks of myocarditis and pericarditis. Additionally, the FDA and CDC have several systems in place to continuously monitor the safety of the COVID-19 vaccine and enable rapid detection and investigation of potential safety issues.

Information sheets for vaccines intended for recipients and caregivers and health care providers contain information on potential side effects, including the risk of myocarditis and pericarditis. The most common side effects reported by people who received a booster dose of the vaccines were pain, redness and swelling at the injection site, as well as fatigue, headache, muscle or joint pain and chills. Of note, swollen armpit lymph nodes were seen more frequently after the booster dose than after the two-dose primary series.

The FDA did not hold a meeting of the Vaccines and Related Biologics Advisory Committee on these actions because the agency previously convened the committee for in-depth discussions regarding the use of booster doses of COVID-19 vaccines. and, after reviewing the USAs of Pfizer and Moderna. requests, the FDA concluded that the requests did not raise issues that would benefit from further discussion by committee members.

Amendments to the USA have been granted to ModernaTX Inc. and Pfizer Inc.

Related information

###

master key

The FDA, an agency of the U.S. Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biologicals for human and veterinary use, as well as medical devices. . The agency is also responsible for the safety and security of our country’s food supply, cosmetics, dietary supplements, products that emit electronic radiation, and the regulation of tobacco products.