For immediate release:

Today, the United States Food and Drug Administration took action to expand the use of a booster dose for COVID-19 vaccines in eligible populations. The agency is amending the Emergency Use Authorizations (EUA) for COVID-19 vaccines to allow the use of a single booster dose as follows:

  • The use of a single booster dose of Moderna COVID-19 vaccine that can be given at least 6 months after the end of the primary series to individuals:
    • 65 and over
    • 18 to 64 at high risk of severe COVID-19
    • 18 to 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2
  • The use of a single booster dose of the COVID-19 vaccine from Janssen (Johnson and Johnson) can be given at least 2 months after the end of the primary single-dose regimen to people 18 years of age and older.
  • Use of each of the available COVID-19 vaccines as a heterologous (or “mix and match”) booster dose in eligible individuals after completion of the primary series with another available COVID-19 vaccine.
  • Specify that a single booster dose of the Pfizer-BioNTech COVID-19 vaccine can be administered at least 6 months after the end of the primary series to people aged 18 to 64 years with frequent institutional or occupational exposure to SARS-CoV- 2.

“Today’s actions demonstrate our commitment to public health in proactively addressing the COVID-19 pandemic,” said Acting FDA Commissioner Janet Woodcock, MD “As the pandemic continues to grow impact the country, science has shown that vaccination continues to be the safest and most effective way to prevent COVID-19, including the most serious consequences of the disease, such as hospitalization and the death. The available data suggest a decrease in immunity in some fully vaccinated populations. The availability of these licensed boosters is important for continued protection against COVID-19 disease. “

“The changes to emergency use authorizations to include a single booster dose in eligible populations are based on available data and information and follow feedback from members of our advisory committee who have supported the use of a booster dose of these vaccines in eligible populations, ”said Peter Marks, MD, Ph.D., director of the Center for Biologics Evaluation and Research at the FDA. “We are also taking steps today to include the use of mix and match boosters to address this public health need. We will endeavor to accumulate additional data as quickly as possible to further assess the benefits and risks of using booster doses in other populations and plan to update the healthcare community and the public with our determination in the coming weeks. “

Authorization of the booster dose of Moderna COVID-19 vaccine

To support the authorization for the emergency use of a single booster dose of the Moderna COVID-19 vaccine, the FDA analyzed immune response data from 149 participants aged 18 and older from original clinical studies that have received a booster dose at least 6 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 of 149 participants against the SARS-CoV-2 virus 29 days after a booster dose of the vaccine demonstrated a booster response.

The FDA also assessed additional analysis from Moderna comparing COVID-19 levels accumulated during the Delta variant wave in July and August 2021, which suggests that there is a decrease in vaccine effectiveness over time. .

Safety was evaluated in 171 participants aged 18 years and older who were followed for about six months on average. The most common side effects reported by clinical trial participants who received the booster dose of the vaccine were injection site pain, fatigue, headache, muscle and / or joint pain, chills, swelling of the lymph nodes in the same arm as the injection, nausea and vomiting and fever. It should be noted that swollen lymph nodes in the armpits were seen more frequently after the booster dose than after the primary two-dose series.

Ongoing scans from the FDA and Centers for Disease Control and Prevention (CDC) safety monitoring systems have identified increased risks of inflammatory heart disease, myocarditis and pericarditis, following vaccination with the Moderna COVID vaccine -19, especially after the second dose. Usually, the onset of symptoms occurred a few days after vaccination. The observed risk is higher in men under 40, especially men aged 18 to 24, than in older women and men.

The single booster dose of Moderna COVID-19 is half the dose that is given for a primary series dose and is given at least six months after the end of a primary series of the vaccine.

Janssen (Johnson and Johnson) clearance COVID-19 Vaccine Booster Dose

Authorization for emergency use of a single booster dose of the Janssen COVID-19 vaccine is based on the FDA’s assessment of immune response data in 39 participants of a clinical trial, including 24 participants aged from 18 to 55 years old and 15 participants who were 65 years and older. Study participants received a booster dose approximately 2 months after their first dose, and the results demonstrated a booster response.

Overall, about 9,000 clinical trial participants received two doses of the Janssen COVID-19 vaccine given at least two months apart and of these, about 2,700 had at least two months of post-treatment safety follow-up. booster dose. Janssen’s safety analyzes from these studies did not identify any new safety issues.

Previous analyzes from the FDA and CDC safety monitoring systems suggest an increased risk of a severe and rare type of blood clot in combination with a low blood platelet count after the Janssen COVID-19 vaccine is administered. This serious condition is called thrombocytopenia syndrome (TTS). People who developed TTS after receiving the vaccine had symptoms that started about one to two weeks after the vaccination. Reporting of TTS was highest among women aged 18 to 49. Additionally, safety monitoring suggests an increased risk of a specific serious neurological disorder called Guillain Barré syndrome, within 42 days of receiving the Janssen COVID-19 vaccine.

Authorization of the “Mix and Match” Dose Booster

Today, the FDA is also authorizing the use of heterologous (or “mix and match”) booster doses for currently available COVID-19 vaccines (that is, authorized or approved by the FDA). Following a presentation of clinical trial data from the National Institute of Allergy and Infectious Diseases, the Vaccines and Related Biologics Advisory Committee’s discussion of the information submitted for review, as well as the Agency assessment of the available data, the FDA determined that the potential benefits of using a single heterologous booster dose outweigh the known and potential risks of their use in eligible populations.

A single booster dose of any of the available COVID-19 vaccines can be given as a heterologous booster dose after completion of the primary series with another available COVID-19 vaccine. The eligible population (s) and the dosage interval for a heterologous booster dose are the same as those authorized for a booster dose of the vaccine used in primary vaccination.

For example, Janssen COVID-19 vaccine recipients aged 18 and over may receive a single booster dose of Janssen COVID-19 vaccine, Moderna COVID-19 vaccine (half dose), or Pfizer-BioNTech COVID- vaccine. 19 at least two months after receiving their primary Janssen COVID-19 vaccine.

In another example, recipients of the Moderna COVID-19 vaccine and the Pfizer-BioNTech COVID-19 vaccine falling into one of the categories allowed for recalls (65 and over, 18 to 64 at high risk of COVID-19 severe, and 18 to 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2) may receive a booster dose of Moderna COVID-19 vaccine (half-dose), Pfizer-BioNTech COVID-19 vaccine or Janssen COVID-19 vaccine at least six months after completing their primary immunization.

The agency acknowledges that healthcare providers and COVID-19 vaccine recipients will have questions about booster doses. Individual information sheets for each vaccine available provide relevant information for health care providers and people vaccinated. The agency encourages healthcare providers to also follow the recommendations that will be provided by the CDC following a meeting of their advisory committee on immunization practices and formal recommendations signed by the CDC director.

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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.