(GNB- Washington): The Food and Drug Administration authorized Johnson & Johnson’s vaccine for emergency use Saturday, a day after a panel of advisers to the agency recommended unanimously in its favor.
This is a third COVID-19 vaccine approved by FDA for the emergency use.
“The Food and Drug Administration (FDA) issues an Emergency Use Authorization (EUA) for emergency use of the Janssen COVID‑19 Vaccine for the prevention of Coronavirus Disease 2019 (COVID-19) for individuals 18 years of age and older, as described in the Scope of Authorization (Section II) of this letter, pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the FD&C Actor the Act) (21 U.S.C. 360bbb3), FDA wrote a letter to Johnson & Johnson.
An expert advisory panel of the Food and Drug Administration (FDA) yesterday recommended that the COVID-19 vaccine developed by Johnson & Johnson be authorized for emergency use in adults during the pandemic.
The COVID-19 vaccine developed by Johnson & Johnson requires only one shot for protection.
The Johnson & Johnson vaccine was tested in an international study of about 40,000 people, half of whom got the vaccine and half of whom got a placebo.
The study found the company’s vaccine to be 66% effective overall in preventing moderate to severe COVID-19 disease. For disease judged severe or critical, the effectiveness was 85%. The study was conducted in the U.S., South America and South Africa.
The overall efficacy figures are lower than Pfizer’s 95% for preventing COVID-19 disease and 94% for Moderna, according to the study.
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