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
FDA seeks feedback on measuring AI-enabled medical device performance
The Food and Drug Administration today issued a request for public comment on a series of questions regarding current approaches to evaluating artificial…
Headline
Olympus recalls endoscope needles
The Food and Drug Administration yesterday announced that Olympus issued a global recall of its ViziShot 2 FLEX needles manufactured prior to May 12 following…
Headline
ACIP recommends patients consult their provider for COVID-19 vaccine
The Advisory Committee on Immunization Practices Sept. 19 recommended that patients should consult their health care provider if they want to receive a COVID-…
Headline
FDA issues serious recall for electric wheelchair joysticks
The Food and Drug Administration has identified a Class I recall for Mo-Vis BVBA R-net Joysticks due to a firmware error that causes the wheelchair to ignore…
Headline
CDC says COVID-19 cases growing or likely growing in 45 states 
COVID-19 infections are growing or likely growing in 45 states and not changing in five states, according to the latest data from the Centers for Disease…
Headline
FDA announces recall of cefazolin by Sandoz for mislabeling
The Food and Drug Administration July 15 announced a recall by Sandoz on certain lots of cefazolin, due to the lots being mislabeled as penicillin G potassium…