The Food and Drug Administration’s staff endorsed Johnson & Johnson‘s COVID-19 vaccine for emergency use, a critical step in bringing a third shot to the US marketplace.
The staff report released earlier this morning is meant to brief the FDA’s Vaccines and Related Biological Products Advisory Committee, which will meet this Friday to review J&J’s request for emergency use authorization.
NO specific safety concerns were identified when analyzed by age, race and comorbidities, according to the agency. There were NO reports of anaphylaxis, a severe and potentially life-threatening allergic reaction, according to the report. The FDA said the most common side effects reported were headache and fatigue, followed by muscle aches, nausea and fever.
If approved, J&J’s application would be the third COVID-19 vaccine authorized for emergency use in the US following those developed by Pfizer and Moderna.
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