FDA Authorizes First One-Shot COVID-19 Vaccine For Emergency Use

The Food and Drug Administration authorized Johnson & Johnson’s COVID-19 vaccine for emergency use late Saturday evening, clearing the way for members of the American public to start receiving the nation’s first single-shot COVID-19 vaccine as soon as this week.

“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 statement Saturday. “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.”

“The authorization of this vaccine expands the availability of vaccines, the best medical prevention method for #COVID19, to help us in the fight against this pandemic, which has claimed over half a million lives in the United States.” – Acting FDA Commissioner @DrWoodcockFDA

— U.S. FDA (@US_FDA) February 27, 2021

An FDA panel unanimously endorsed the Johnson & Johnson vaccine candidate Friday, signaling that emergency authorization for a third COVID-19 vaccine for the American public would come shortly. The vaccine has not been authorized for children.

Back in January, Johnson & Johnson announced that its vaccine candidate was shown to be 72% effective against COVID-19, and 66% effective at preventing moderate to severe COVID-19 beginning 28 days after vaccination. Furthermore, the Johnson & Johnson vaccine was shown to provide “complete protection” from COVID-19-related hospitalization and death beginning 28 days after the recipient had been vaccinated.

“A one-shot vaccine is considered by the World Health Organization to be the best option in pandemic settings, enhancing access, distribution and compliance,” said Dr. Paul Stoffels, chief scientific officer at Johnson & Johnson, back in January. “Eighty-five percent efficacy in preventing severe COVID-19 disease and prevention of COVID-19-related medical interventions will potentially protect hundreds of millions of people from serious and fatal outcomes of COVID-19. It also offers the hope of helping ease the huge burden placed on healthcare systems and communities.”

The authorization of the Johnson & Johnson coronavirus vaccine marks yet another tool developed in recent months to help reign in the pandemic. The FDA has authorized two other COVID-19 vaccines for emergency use — one from Pfizer-BioNTech, and the other from Moderna — but both of them require follow-up as part of the two-dose regimen.

According to data from The Washington Post, at least 48.4 million people in the United States have received at least one shot of COVID-19 vaccine, and 23.7 million of those people have been fully vaccinated with either the Moderna or Pfizer-BioNTech vaccines.

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