FDA Committee Votes to Recommend New Johnson & Johnson COVID-19 Vaccine for EUA

,

In voting in favor of the recommendation, 22 committee members unanimously agreed that the benefits of the Johnson & Johnson COVID-19 vaccine outweigh its risks.

The FDA’s Vaccines and Related Biological Products Advisory Committee has recommended an emergency use authorization (EUA) for Johnson & Johnson’s single-dose COVID-19 vaccine. The vaccine under review was developed by the company’s Janssen division.

In voting in favor of the recommendation, 22 committee members unanimously agreed that the benefits of the Janssen COVID-19 vaccine outweigh its risks in individuals age 18 years and older, based on the totality of scientific evidence currently available.1

If granted an EUA, the Janssen COVID-19 vaccine would be the third approved vaccine for COVID-19, in the United States following the EUA for Pfizer and BioNTech’s vaccine on December 12, 2020, and the EUA for Moderna’s vaccine on December 19.

In his comments to the committee following the vote, Jay Portnoy, MD, said he believes the Janssen COVID-19 vaccine is as safe and effective as other vaccines currently approved by the FDA, such as influenza vaccines.1

“The main thing to keep in mind is that we’re dealing with a pandemic right now….There is an urgency to get this done. We’re in a race between the virus mutating, new variants coming out that can cause further disease, and stopping it. The fewer people who are infected with the virus the less opportunity it has to emerge as a more virulent strain,” said Portnoy.1

On Wednesday, a released FDA analysis confirmed that the vaccine provides strong protection against severe disease and may reduce transmission of the virus. It is a replication-incompetent adenovirus type 26 vectored vaccine with a stabilized variant of the SARS-CoV-2 S protein and is approved for adults 18 years of age and older.2

“I do believe its evidence supports the safety and effectiveness,” Portnoy said.1

The single-dose approach would enable vaccination of hard-to-reach populations, such as homeless individuals and those in rural communities. The vaccine is also easier to store, remaining stable at normal refrigeration temperatures for up to 3 months.2

According to a joint statement by Janet Woodcock, MD, the FDA's acting commissioner; and Peter Marks, MD, PhD, director of the agency's Center for Biologics Evaluation and Research, issued following the advisory committee's meeting earlier today, the FDA will rapidly work toward finalization and issuance of an EUA. "The agency has also notified our federal partners involved in vaccine allocation and distribution so they can execute their plans for timely vaccine distribution," said Woodcock and Marks in their statement.3

REFERENCES

  • Vaccine and Related Biological Products Advisory Committee—2/26/21. FDA. Accessed February 26, 2021. https://www.youtube.com/watch?v=Qd7mlCD-rEA&feature=youtu.be
  • FDA Analysis Finds Johnson & Johnson Single Shot COVID-19 Vaccine Protects Against Severe Illness, May Reduce Transmission. Pharmacy Times; February 24, 2021. Accessed February 26, 2021. https://www.pharmacytimes.com/news/fda-analysis-finds-johnson--johnson-single-shot-covid-19-vaccine-protects-against-severe-illness-may-reduce-transmission
  • FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting [news release]. Silver Spring, MD; February 26, 2021: FDA. Accessed February 26, 2021. https://www.fda.gov/news-events/press-announcements/fda-statement-vaccines-and-related-biological-products-advisory-committee-meeting-1