Johnson & Johnson Requests EUA, FDA Schedules VRBPAC Meeting Date
On Thursday, Johnson & Johnson’s pharmaceutical division Janssen Biotech, Inc. requested from the U.S. Food and Drug Administration (FDA) an emergency use authorization (EUA) for its single-dose COVID-19 vaccine. According to Johnson & Johnson, the COVID-19 vaccine has a 72 percent efficacy rate in the U.S., but only a 57 percent efficacy rate in South Africa, raising concerns about the role of COVID-19 variants in continued transmission.
Following Johnson & Johnson’s EUA request, the FDA scheduled a meeting for its Vaccines and Related Biological Products Advisory Committee (VRBPAC) to review safety and efficacy data for February 26, 2021. VRBPAC will be ultimately tasked with recommending to the FDA whether Johnson & Johnson’s EUA should be approved. If the FDA does approve the EUA, Johnson & Johnson is expected to begin shipping its one-dose vaccine as early as March.
An announcement from the FDA is available here.