- For immediate release:
Today, the US Food and Drug Administration took action to expand the use of a booster dose for COVID-19 vaccines in eligible populations. The agency is changing the emergency 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 may be administered to subjects at least 6 months after completion of the primary series:
- 65 years and older
- 18 to 64 years 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 Janssen (Johnson and Johnson) COVID-19 vaccine may be administered to individuals 18 years of age and older at least 2 months after completion of the primary single dose schedule.
- The use of any of the available COVID-19 vaccines as a heterologous (or “mix and match”) booster dose in eligible individuals upon completion of primary vaccination with another available COVID-19 vaccine.
- To clarify that a single booster dose of the Pfizer-BioNTech COVID-19 vaccine may be administered at least 6 months after completion of the primary series to individuals 18 to 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2.
“Today’s actions demonstrate our commitment to public health by proactively fighting the COVID-19 pandemic,” said Acting FDA Commissioner Janet Woodcock, MD “As the pandemic continues to affect the country, science has shown that vaccination continues to the safest and most effective way to prevent COVID-19, including the most serious consequences of the disease, such as hospitalization and death.The available data indicate declining immunity in some fully vaccinated populations. The availability of these authorized boosters is important for continued protection against COVID-19 disease.”
“The changes to the emergency authorizations to include a single booster dose in eligible populations are based on the available data and information and follow input from members of our advisory committee who support the use of a booster dose of these vaccines in eligible populations,” said Peter Marks, MD, Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “We are also taking action today to include the use of mix and match boosters to meet this public health need. We will work to collect additional data as soon as possible to further assess the benefits and risks of using booster doses in additional populations and plan to update the healthcare industry and the public with our determination in the coming weeks. .”
Authorization of Moderna COVID-19 Vaccine Booster Dose
To support the emergency use authorization of a single booster dose of Moderna COVID-19 vaccine, the FDA analyzed immune response data from 149 participants aged 18 years and older from the original clinical studies who received a booster dose at least 6 months after their second dose and compared it to the immune responses of 1055 study participants after completing their two-dose series. The antibody response of the 149 participants against the SARS-CoV-2 virus 29 days after a booster dose of the vaccine showed a booster response.
The FDA also reviewed additional analysis from Moderna, which compared rates of COVID-19 contracted during the Delta variant surge in July and August 2021, suggesting vaccine effectiveness over time. decreases.
Safety was evaluated in 171 participants aged 18 years and older who were followed for an average of approximately six months. The most commonly reported adverse reactions by the clinical study participants who received the booster dose of the vaccine were injection site pain, fatigue, headache, muscle and/or joint pain, chills, swollen lymph nodes in the same arm as the injection, nausea and vomiting and fever. Note that swollen lymph nodes in the forearm were observed more frequently after the booster dose than after the primary series of two doses.
Ongoing analyzes from the FDA and Centers for Disease Control and Prevention (CDC) safety surveillance systems have identified increased risks of inflammatory heart disease, myocarditis and pericarditis following vaccination with the Moderna COVID-19 vaccine, particularly after the second dose. The onset of symptoms is usually a few days after vaccination. The observed risk is higher in men under 40 years of age, especially men 18 to 24 years of age, than in women and older men.
The single booster dose of Moderna COVID-19 is half the dose administered for a primary series dose and is administered at least six months after completion of a primary series of vaccine.
Authorization of Janssen (Johnson and Johnson) COVID-19 Vaccine Booster Dose
The emergency use authorization of a single booster dose of the Janssen COVID-19 vaccine is based on the FDA’s evaluation of immune response data in 39 participants from a clinical trial of 24 participants aged 18 to 55 years and 15 participants who were 65 years and older. The study participants were given a booster dose about 2 months after their first dose, and the results showed a booster response.
In total, approximately 9,000 clinical trial participants have received two doses of Janssen COVID-19 vaccine at least two months apart and of these, approximately 2,700 have had at least two months of safety checks after the booster dose. Janssen’s safety analyzes from these studies have not revealed any new safety issues.
Previous analyzes of the FDA and CDC’s safety monitoring systems indicate an increased risk of a serious and rare type of blood clot associated with low platelets following administration of the Janssen COVID-19 vaccine. 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 vaccination. The reporting of TTS was highest in women aged 18 to 49 years. In addition, safety surveillance suggests an increased risk of a specific serious neurological disorder, Guillain Barré syndrome, within 42 days of receiving the Janssen COVID-19 vaccine.
Authorization of “Mix and Match” booster dose
Today, the FDA also authorizes the use of heterologous (or “mix and match”) booster doses for currently available (i.e., FDA-authorized or approved) COVID-19 vaccines. Following a presentation of clinical trial data from the National Institute of Allergy and Infectious Diseases, a discussion by the Vaccines and Related Biological Products Advisory Committee of the information submitted for consideration, along with the agency’s evaluation of the available data, the FDA has determined that the known and potential benefits of using a single heterologous booster dose outweigh the known and potential risks of its use in eligible populations.
A single booster dose of one of the available COVID-19 vaccines can be administered as a heterologous booster dose upon completion of the primary vaccination with another available COVID-19 vaccine. The eligible population(s) and dosing interval for a heterologous booster dose are the same as those approved for a booster dose of the vaccine used for primary vaccination.
For example, recipients of the Janssen COVID-19 vaccine aged 18 and older can receive their primary vaccination course at least two months after receiving their Janssen COVID-19 Vaccine.
In another example, Moderna COVID-19 vaccine and Pfizer-BioNTech COVID-19 vaccine recipients who fall into one of the permitted booster categories (aged 65 and over, 18 to 64 at high risk of severe COVID-19 and Ages 18 to 64 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 at least six months after completing their primary vaccination course.
The agency recognizes that health care providers and recipients of COVID-19 vaccines will have questions about booster doses. The individual fact sheets for each available vaccine provide relevant information for healthcare providers and vaccine recipients. The agency also encourages health care providers to follow the recommendations that will be provided by the CDC after a meeting of their Advisory Committee on Immunization Practices and formal recommendations signed by the CDC director.
The FDA, an agency within the United States Department of Health and Human Services, protects public health by ensuring the safety, effectiveness, and security of human and animal medicines, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our country’s food supply, cosmetics, nutritional supplements, products that emit electronic radiation, and for regulating tobacco products.