The Food and Drug Administration’s (FDA’s) Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet Feb. 26 to discuss the emergency use authorization (EUA) request for a COVID-19 vaccine from Janssen Biotech Inc.
In clinical trials, the single-shot vaccine was 72 percent effective in preventing moderate to severe COVID-19 infection in U.S. patients and 66 percent effective worldwide.
The vaccine is estimated to remain stable for two years at minus 4 degrees Fahrenheit (F), at least three months of which can be at temperatures of 36 to 46 F.
If FDA grants an EUA, Janssen would join Pfizer and Moderna, which received EUAs for their COVID-19 vaccines in December 2020.
Vaccine Data Reporting Lacks Race, Ethnicity Data
The Centers for Disease Control and Prevention (CDC) Feb. 8 reported more than 42.4 million vaccine doses have been administered nationwide.
CDC’s Feb. 5 Morbidity and Mortality Weekly Report examines demographics of those vaccinated from Dec. 14, 2020, to Jan. 14, 2021. While racial and ethnic disparities exist, it is difficult to know their extent, as race and ethnicity was unknown or not reported for 48.1 percent of vaccine recipients during this time.
CDC encourages more thorough reporting of race and ethnicity data to better identify disparities and work toward equitable vaccine administration.