Image Credits: Mark Lennihan, File
The FDA authorized booster doses of Moderna and Johnson & Johnson’s COVID-19 vaccines and also authorized a “mix and match” or heterologous approach to boosters for all three available vaccines (including Pfizer’s) in the indicated populations, the agency announced on Wednesday.
A booster of Johnson & Johnson vaccine is authorized for all adults ages 18 and up who received the Johnson & Johnson vaccine, at least 2 months after completion of the single-dose regimen.
Authorization of Janssen (Johnson and Johnson) COVID-19 Vaccine Booster Dose
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 2 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 and of these, approximately 2,700 have had at least two months of safety follow-up after the booster dose. 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 in combination with low blood 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 began about one to two weeks after vaccination. Reporting of TTS has been highest in females ages 18 through 49 years. In addition, safety surveillance suggests an increased risk of a specific serious neurological disorder called Guillain Barré syndrome, within 42 days following receipt of the Janssen COVID-19 Vaccine.
Authorization of “Mix and Match” Booster Dose
Today, the FDA is also authorizing the use of heterologous (or “mix and match”) booster dose 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, 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 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 agency encourages health care 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.