Emergency Use Authorization Granted for Johnson & Johnson’s COVID-19 Vaccine

February 27, 2021 – The U.S. FDA has granted Emergency Use Authorization (EUA) to Johnson & Johnson’s COVID-19 vaccine, which is manufactured by the Johnson & Johnson subsidiary Janssen Pharmaceuticals. Under the EUA, the vaccine is authorized to prevent COVID-19 caused by the SARS-CoV-2 virus in individuals who are at least 18 years old.

Emergency Use Authorization does not constitute FDA approval. Instead, it provides a mechanism by which the agency facilitates availability and use of unapproved medical products during public health emergencies in the absence of suitable FDA-approved alternatives. EUAs can be revoked once use of the product no longer meets the conditions required for emergency use authorization.

The Johnson & Johnson vaccine received its EUA based on the current totality of available evidence. In clinical studies, the vaccine was 67% effective in preventing moderate to severe COVID-19 at least 14 days following vaccination, and 77% effective in preventing severe to critical COVID-19. Efficacy in preventing severe to critical COVID-19 increased to 85% at least 28 days after vaccination. Recommended dosing is a single, 0.5mL intramuscular injection administered by a healthcare professional.

This marks the third EUA granted in the U.S. for a COVID-19 vaccine. The FDA’s full announcement of the EUA can be found on the agency’s website.