Authorization

FDA Authorizes Emergency Use Of Johnson & Johnson's Single-dose COVID-19 Vaccine

(RTTNews) - The U.S. Food and Drug Administration on Saturday authorized Johnson & Johnson's (JNJ) single-dose COVID-19 vaccine for emergency use.

It is the first single-shot COVID-19 vaccine and the third COVID-19 vaccine for emergency use in the U.S. - the other two being Pfizer/BioNTech's BNT162b2 and Moderna's mRNA-1273.

The FDA has issued emergency use authorization for the vaccine, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson, to prevent COVID-19 in individuals 18 years of age and older.

The emergency use authorization follows a unanimous vote by the U.S. FDA's Vaccines and Related Biological Products Advisory Committee on Friday.

The vaccine, known as Ad26.COV2.S, was found to be 85 percent effective at preventing COVID-19 in clinical trials. Phase 3 Ensemble study showed protection against COVID-19 related hospitalization and death, beginning 28 days after vaccination, Johnson & Johnson said in a statement.
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