COVID-19: Vaccine Approval Process / Racial Disparities in Mortality

By the Editors

Here are some of the latest developments in COVID-19:

Vaccine approval process: In the New England Journal of Medicine, FDA officials lay out the rationale for a median 2 month follow-up requirement for vaccines to receive emergency use authorization. For instance, most adverse events typically occur within 6 weeks of receiving a vaccine. In addition, if a vaccine's protective effects are short-lived, the immune response may begin to wane in the second month, they write. The World Health Organization requires a median 3 months' follow-up for COVID-19 vaccines in its emergency use program. In comparison, participants in the clinical trials investigating the Shingrix shingles vaccine were followed for a median of 3.1–3.9 years.

Racial disparities: Minorities in the U.S. had a higher burden of COVID-19 mortality than whites this summer, with significant growth among Hispanic people, according to new data from the CDC published in MMWR. An analysis of over 100,000 COVID-19 deaths in the U.S. from May to August found that 51% of those that died were non-Hispanic white, 24% were Hispanic or Latino, and 19% were Black. In comparison, Hispanics make up about 19% of the U.S. population and Blacks represent 13%. The percentage of fatalities who were Hispanic rose from 16% to 26% during this time. The authors write: "These results can inform public health messaging and mitigation efforts focused on prevention and early detection of infection among disproportionately affected groups so as to minimize subsequent mortality."