FDA issues emergency authorization for Johnson and Johnson COVID-19 vaccine

The U.S. Food and Drug Administration (FDA) issued late last week an emergency use authorization for the third novel coronavirus (COVID-19) vaccination, the Janssen COVID-19 Vaccine manufactured by Johnson & Johnson, according to an announcement made by the agency.

The vaccine is the first single-shot option for the prevention of SARS-CoV-2, the virus that causes COVID-19. The vaccine is the third to receive emergency authorization from the FDA, following two-dose competitors by Pzifer and BioNTech and Moderna. The emergency use authorization allows the vaccine to be distributed in the U.S. for use in individuals 18 years of age and older.

The Janssen COVID-19 Vaccine is manufactured using a specific type of virus called 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 viruses that are relatively common, 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. After a person receives this vaccine, the body can temporarily make the spike protein, which does not cause disease, but rather triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.

Johnson and Johnson announced in January preliminary results from its international study, which found the vaccine was safe and 66 percent effective overall at preventing moderate to severe COVID-19 28 days after vaccination. The company submitted an application to the FDA in early February. Healthcare experts say the single-dose option could be easier and help boost vaccination supplies.

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