VRBPAC Recommends EUA for Johnson & Johnson Single-Dose COVID-19 Vaccine

Today, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) met to review and discuss the emergency use authorization (EUA) request from Janssen Biotech, Inc. for its Johnson & Johnson COVID-19 vaccine, ultimately recommending on a unanimous vote that the U.S. Food and Drug Administration (FDA) issue an EUA for the single-dose vaccine.

The Johnson & Johnson vaccine was tested in an international study of approximately 40,000 participants. The vaccine was found to be 66 percent effective in preventing moderate to severe COVID-19 cases and 85 percent effective in critical COVID-19 cases. The FDA is anticipated to approve the EUA for the Johnson & Johnson vaccine as early as this weekend with shipping and distribution of the vaccine commencing as early as next week.

The CDC Advisory Committee on Immunization Practices (ACIP) is scheduled to meet on Sunday and Monday to further review the Johnson & Johnson vaccine and issue its recommendations. The Western State Scientific Safety Review Workgroup is similarly anticipated to convene its review of the Johnson & Johnson vaccine over the coming days.

According to Johnson & Johnson, four million doses of the vaccine could be available in the U.S. as soon as the FDA issues its EUA, increasing to 20 million doses by the end of March. Johnson & Johnson has maintained its commitment to providing the U.S. federal government with 100 million doses by the end of June.

The VRBPAC meeting materials are accessible here.