FDA Issues EUA for Third COVID-19 Vaccine

The FDA has issued an Emergency Use Authorization (EUA) for the Janssen COVID19 vaccine. This EUA allows the vaccine to be distributed in the US for people aged above 18 years of age. The Janssen vaccine is manufactured using a specific virus called the adenovirus type 26 (Ad26). The vaccine uses Ad26 to deliver a piece of the DNA, or genetic material, that is used to make the distinctive “spike” protein of the SARS-CoV-2 virus.


While adenoviruses are a group of relatively common viruses, Ad26, which can cause cold symptoms and pink eye, has been modified for the vaccine so that it cannot replicate in the human body to cause illness.


The Janssen vaccine is administered in a single dose. In the clinical trials, 43,783 participants enrolled in an ongoing randomized, placebo-controlled study being conducted in South Africa, certain countries in South America, Mexico, and the U.S. The participants, 21,895 of who received the vaccine and 21,888 of whom received saline placebo, were followed for a median of eight weeks after vaccination. The most commonly reported side effects were pain at the injection site, headache, fatigue, muscle aches, and nausea.


Most of these side effects were mild to moderate in severity and lasted 1-2 days. the vaccine was approximately 67% effective in preventing moderate to severe/critical COVID-19 occurring at least 14 days after vaccination and 66% effective in preventing moderate to severe/critical COVID-19 occurring at least 28 days after vaccination. Additionally, the vaccine was approximately 77% effective in preventing severe/critical COVID-19 occurring at least 14 days after vaccination and 85% effective in preventing severe/critical COVID-19 occurring at least 28 days after vaccination.


Ref Link:

https://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-third-covid-19-vaccine

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