FDA advisory panel recommends authorizing J&J booster for adults

Oct 15, 2021 - 12:43 PM
FDA-guidance

Available data support the safety and effectiveness of the Johnson & Johnson COVID-19 vaccine for emergency use authorization as a booster dose in individuals aged 18 and older at least two months after an initial single dose, the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee voted 19-0 today. The committee also discussed early data from a study sponsored by the National Institute of Allergy and Infectious Diseases evaluating the immunogenicity of each of the three authorized COVID-19 vaccines following immunization with the same or a different booster dose.

The committee yesterday voted unanimously to recommend boosters for previous Moderna recipients age 65 and older, plus individuals age 18-64 if they are at high risk of severe COVID-19 or whose frequent institutional or occupational exposure puts them at high risk of serious complications, including severe COVID-19. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will consider the recommendations next week. FDA last month amended Pfizer’s emergency use authorization for its COVID-19 vaccine to allow for an additional, booster dose for certain individuals.

 

Related News Articles

Headline
Survey: Less than 20% of U.S. adults concerned for themselves or family receiving infection ahead of respiratory virus season
The National Foundation for Infectious Diseases Sept. 25 released a survey showing that less than one in five U.S. adults are concerned about themselves or a…
Headline
FDA authorizes combination tests for flu, COVID-19
The Food and Drug Administration Aug. 22 granted emergency use authorization for two new combined COVID-19 and influenza tests. The Nano-Check Influenza-COVID-…
Headline
CDC: COVID-19 surging across the U.S.
The Centers for Disease Control and Prevention's COVID-19 data tracker shows an 18.1% test positivity rate for the week ending Aug. 10, the highest it has been…
Headline
CDC issues advisory on increased parvovirus B19 cases in the U.S. 
The Centers for Disease Control and Prevention Aug. 13 issued an advisory alerting of an uptick of cases of parvovirus B19 across the U.S. Parvovirus B19 is a…
Headline
CDC encourages older adults to get additional COVID-19 vaccine dose 
Adults age 65 and older are encouraged to receive an updated dosage of the COVID-19 vaccine, the Centers for Disease Control and Prevention announced April 25…
Headline
NASEM releases evidence review on COVID-19 vaccine safety
The Pfizer and Moderna COVID-19 vaccines can cause myocarditis, but do not appear to cause infertility, Guillain-Barré syndrome, Bell’s palsy, thrombosis with…