Third COVID-19 Vaccine Gets Green Light

FDA issues emergency use authorization for one-dose COVID-19 vaccine

(RxWiki News) The US Food and Drug Administration (FDA) has approved a third COVID-19 vaccine. And this one only requires one dose.

The FDA issued an emergency use authorization (EUA) for the Janssen COVID-19 Vaccine to be used in adults.

“The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for COVID-19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States,” said Acting FDA Commissioner Dr. Janet Woodcock in a press release. “The FDA, through our open and transparent scientific review process, has now authorized three COVID-19 vaccines with the urgency called for during this pandemic, using the agency’s rigorous standards for safety, effectiveness and manufacturing quality needed to support emergency use authorization.”

Unlike the other two approved vaccines, this one requires only one dose. This could help to speed up distribution of vaccines because people do not have to return for a follow-up appointment for a second dose.

Before issuing an EUA for this vaccine, the FDA reviewed it for safety and effectiveness. The agency determined that the vaccine's "known and potential benefits outweigh its known and potential risks," according to an FDA press release.

“After a thorough analysis of the data, the FDA’s scientists and physicians have determined that the vaccine meets the FDA’s expectations for safety and effectiveness appropriate for the authorization of a vaccine for emergency use,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, in a press release.

The FDA said it expects vaccine manufacturers to continue clinical trials of their COVID-19 vaccines to obtain full approval beyond an EUA.

Side effects of this COVID-19 vaccine included injection-site reactions, nausea, muscle aches, headaches and fatigue.

Talk to your health care provider about when you can receive the COVID-19 vaccine.

The FDA issued this EUA to Janssen Biotech Inc., a Janssen Pharmaceutical Company of Johnson & Johnson.

Review Date: 
March 1, 2021