U.S. FDA Changes COVID-19 Vaccination Authorizations
The U.S. Food and Drug Administration (FDA) announced various actions to expand the use of COVID-19 vaccines in eligible populations.
The FDA amended the emergency use authorizations (EUA) for FDA Authorized or Approved COVID-19 vaccines to allow for the heterologous (“mix and match”) use of a single booster dose.
And the FDA confirmed the increased risks of inflammatory heart conditions for younger men following mRNA vaccination.
The highlight changes are as follows:
- The use of a single booster dose of the Moderna COVID-19 Vaccine (SpikeVax) that may be administered at least six months after completion of the primary series to individuals 65 years of age and older; 18 through 64 years of age at high risk of severe COVID-19; 18 through 64 years of age with frequent institutional or occupational exposure to the SARS-CoV-2 betacoronavirus.
- Use of a single booster dose of the Janssen (Johnson and Johnson) COVID-19 Vaccine may be administered at least two months after completion of the single-dose primary regimen to individuals 18 years of age and older.
- The use of each of the available COVID-19 vaccines as a heterologous (or “mix and match”) booster dose in eligible individuals following primary vaccination with a different available COVID-19 vaccine.
- The FDA clarified that a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine (Comirnaty) may be administered at least six months after completing the primary series to individuals 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2.
The FDA finalized its heterologous vaccination decision following a presentation of clinical trial data from the National Institute of Allergy and Infectious Diseases, the Vaccines and Related Biological Products Advisory Committee’s discussion of 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 the use of 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 may be administered as a heterologous booster dose following completion of primary vaccination with a different available COVID-19 vaccine.
The eligible population(s) and dosing interval for a heterologous booster dose are the same as those authorized for a booster dose of the vaccine used for primary vaccination.
“The amendments to the emergency use authorizations to include a single booster dose in eligible populations are based on the available data and information and follows the input from the members of our advisory committee who were supportive of the use of a booster dose of these vaccines in eligible populations,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, in a related press statement.
“We are also taking action today to include the use of mix and match boosters to address this public health need.”
“We will work to accrue additional data as quickly as possible to further assess the benefits and risks of the use of booster doses in additional populations and plan to update the healthcare community and public with our determination in the coming weeks,” added Dr. Marks.
Furthermore, ongoing analyses from the FDA and the U.S. Centers for Disease Control and Prevention (CDC) safety surveillance systems have identified increased risks of inflammatory heart conditions, myocarditis, and pericarditis, following vaccination with the Moderna COVID-19 vaccine, particularly following the second dose.
Typically, the onset of symptoms has been a few days following vaccination.
The observed risk is higher among males under 40 years of age, particularly males 18 through 24, than females and older males.
To support the authorization for emergency use of a single booster dose of the Moderna COVID-19 Vaccine, the FDA analyzed 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 of the 149 participants against the SARS-CoV-2 virus 29 days after a booster dose of the vaccine demonstrated a booster response.
The FDA also evaluated an additional analysis from Moderna comparing the rates of COVID-19 accrued during the Delta variant surge during July and August 2021.
Moderna’s vaccine safety was evaluated in 171 participants 18 years of age and older who were followed for an average of approximately six months.
The most commonly reported side effects by the clinical trial participants who received the booster dose of the vaccine were pain at the injection site, tiredness, headache, muscle and/or joint pain, chills, swollen lymph nodes in the same arm as the injection, nausea, vomiting, and fever.
Of note, swollen lymph nodes in the underarm were observed more frequently following the booster dose than after the primary two-dose series.
Separately, the authorization for emergency use 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, including 24 participants who were 18 through 55 years of age and 15 participants who were 65 years of age and older.
The study participants received a booster dose approximately two months after their first dose, and the results demonstrated a booster response.
Overall, approximately 9,000 clinical trial participants have received two doses of Janssen COVID-19 Vaccine administered at least two months apart. Of these, about 2,700 have had at least two months of safety follow-up after the booster dose.
Furthermore, Janssen’s safety analyses from these studies have not identified new safety concerns.
Earlier analyses from the FDA and CDC safety surveillance systems suggest an increased risk of a serious and rare type of blood clot combined with low blood platelets following the Janssen COVID-19 vaccine administration.
The agency recognizes that health care providers and COVID-19 vaccine recipients will have questions about booster doses. The individual fact sheets for each available vaccine provide relevant information for health care providers and the vaccine recipients:
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for human use and medical devices.
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