FDA Authorizes Johnson & Johnson’s Single-Dose COVID-19 Vaccine, Marking Third Vaccine in US

The Food and Drug Administration (FDA) on Saturday granted emergency use authorization to the Johnson & Johnson COVID-19 Vaccine for the prevention of COVID-19 caused by SARS-CoV-2, marking the third vaccine available in the United States.

“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,” Acting FDA Commissioner Dr. Janet Woodcock said in an agency-issued 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.”

The agency’s decision was based on data from a phase 3 clinical trial of approximately 40,000 individuals. An initial analysis of the ongoing trial demonstrated that the Johnson & Johnson vaccine (as of Jan. 22, 2021) was 66.9% effective in the prevention of moderate to severe/critical infection at least 14 days following vaccination and 66.1% effective at least 28 days after vaccination. The vaccine was also approximately 77% effective in preventing severe/critical infection at least 14 days after vaccination and 85% effective in preventing severe/critical infection at least 28 days after vaccination

Moreover, the vaccine was 85.7% effective against hospitalization from COVID-19 and 100% effective against death from COVID-19. Although there were seven deaths attributed to COVID-19 infection in the trial, all instances occurred in individuals who received the placebo and had at least one comorbidity.

The most common side effects patients reported included fatigue, headache, muscle aches, pain at injection site and nausea.

Overall, the agency ruled the vaccine’s known and potential benefits outweigh its known and potential risks.

“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,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in the release. “With today’s authorization, we are adding another vaccine in our medical toolbox to fight this virus. At the same time, the American people can be assured of the FDA’s unwavering commitment to public health through our comprehensive and rigorous evaluation of the data submitted for vaccines to prevent COVID-19.”

While it is not as effective as either the Pfizer-BioNTech or Moderna Vaccine, the Johnson & Johnson Vaccine can be administered in one dose and does not require a booster shot.

“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,” Woodstock wrote on Twitter. “Through our open (and) transparent scientific review process, we’ve 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 an (emergency use authorization).”

White House Senior Advisor of COVID Response, Andy Slavitt, tweeted on Saturday, “We are ready to roll it out!”

Check back for what patients with cancer and survivors need to know regarding the authorization of a third COVID-19 vaccine.

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