FDA Says J&J COVID Vaccine ‘Safe,’ Emergency Approval Expected Within Days • Children’s Health Defense

The FDA’s report paves the way for the agency to grant Emergency Use Authorization (EAU) for the vaccine’s use in the U.S., according to USA TODAY.

According to the FDA’s report, J&J’s vaccine has an overall efficacy rating of 66% for preventing “moderate to severe COVID-19,” but was even less effective against the new South Africa variant. The vaccine was only 42.3% effective about a month after getting the shot in people 60 or older who had comorbidities, reported CNBC.

According to the FDA analysis, J&J’s vaccine consists of a “replication-incompetent recombinant adenovirus type 26, a SARS-CoV-2 spike protein, and contains the following inactive ingredients: citric acid monohydrate, trisodium citrate dihydrate, ethanol, 2-hydroxypropyl-β-cyclodextrin (HBCD), polysorbate 80, sodium chloride, sodium hydroxide, and hydrochloric acid. The adenovirus is also grown in the PER.C6® aborted fetal cell line.

J&J will face no liability as it brings it’s COVID vaccine to market as the Public Readiness and Emergency Preparedness Act implemented in March 2020 indemnified vaccine manufacturers from harmful effects caused by their products post-approval.

FDA Says J&J COVID Vaccine ‘Safe,’ Emergency Approval Expected Within Days • Children’s Health Defense