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COVID-19 Vaccine Updates

February 27, 2021

FDA Issues Emergency Use Authorization for Janssen COVID-19 Vaccine


On February 27, 2021, the FDA issued an emergency use authorization (EUA) to Janssen Biotech Inc., a Janssen Pharmaceutical Company of Johnson & Johnson. The EUA allows the vaccine to be administered to individuals 18 years of age and older.

Unlike the Pfizer-BioNTech and Moderna COVID-19 vaccines, the Janssen COVID-19 vaccine is not an mRNA vaccine. Instead, the vaccine is manufactured with the adenovirus type 26 (Ad26) virus which can trigger an immune response that defends against SARS-CoV-2.

The FDA evaluation of available safety data showed that most reported side effects were mild to moderate in severity and include pain at the injection site, headache, fatigue, muscle aches, and nausea. The FDA evaluation of available effectiveness data showed that the vaccine was approximately 67% effective in preventing moderate to severe COVID-19 occurring at least 14 days after vaccination and 66% effective in preventing moderate to severe COVID-19 occurring at least 28 days after vaccination. 

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