FDA Issues EUA for Johnson & Johnson COVID-19 Vaccine

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The US Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the third coronavirus disease 2019 (COVID-19) vaccine, allowing the Janssen COVID-19 vaccine to be distributed in the US for use in persons aged ≥18 years.

“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 Peter Marks, MD, PhD, director, FDA’s Center for Biologics Evaluation and Research, in the agency’s February 27, 2021 press 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.”

The FDA’s decision was based on a totality of scientific evidence, including data from the phase 3 ENSEMBLE study that showed the single-dose vaccine—developed by the Janssen Pharmaceutical Companies of Johnson & Johnson—was 85% effective against severe/critical COVID-19 across all regions studied. The study also found that the vaccine was protective against COVID-19-related hospitalization and mortality, beginning 28 days after vaccination.

“We believe the Johnson & Johnson single-shot COVID-19 vaccine is a critical tool for fighting this global pandemic, particularly as it shows protection across countries with different variants,” said Paul Stoffels, MD, vice chairman of the executive committee, chief scientific officer, Johnson & Johnson, in a company press release. “A vaccine that protects against COVID-19, especially against the most dire outcomes of hospitalization and death, will help ease the burden on people and the strain on health systems worldwide.”

Johnson & Johnson has already started shipping its vaccine and expects to deliver enough vaccines by the end of March to enable the full vaccination of >20 million Americans, and plans to deliver 100 million doses to the US in the first half of 2021, according to the company press release.

As part of the EUA, the FDA noted that it is mandatory for both Janssen and vaccination providers to report the following to the Vaccine Adverse Event Reporting System: serious adverse events, cases of Multisystem Inflammatory Syndrome, and COVID-19 cases that result in hospitalization or death.

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