US FDA grants emergency authorization to Johnson & Johnson vaccine

The Food and Drug Administration granted emergency use authorization to Johnson & Johnson’s Covid-19 vaccine on Saturday, adding a third vaccine to the U.S. arsenal to fight the pandemic.

“Today’s emergency use authorization of the Janssen Covid-19 vaccine is another milestone as we work to end the Covid-19 pandemic,” said Dr. Peter Marks, director of the FDA Center for Biologics Evaluation and Research. “Guided by our careful review of the science and data, we have determined that the vaccine’s known potential benefits clearly outweigh its known potential risks.”

The decision comes one day after an advisory committee to the FDA voted unanimously in favor of recommending the vaccine.

“We’re in a race between the virus mutating, with new variants coming out that can cause further disease, and stopping it,” said Dr. Jay Portnoy, a professor of pediatrics at the University of Missouri-Kansas City School of Medicine and a member of the advisory committee.

“The fewer people who are infected with the virus, the less opportunity it has to emerge as a more virulent strain.”

President Joe Biden released a statement after the announcement, calling the decision “exciting news for all Americans, and an encouraging development in our efforts to bring an end to the crisis.”

Doses are expected to begin shipping Monday, starting with about 4 million of them. Johnson & Johnson, which developed the vaccine in partnership with Janssen Pharmaceuticals, said that 20 million doses will be available by the end of March.

That will be enough to fully vaccinate 20 million people, because the Johnson & Johnson vaccine is given as a single dose. The other available vaccines, from Pfizer-BioNTech and Moderna, are given as two doses each, three to four weeks apart.