BioCentury
ARTICLE | Product Development

COVID roundup: J&J submits vaccine to WHO, plus Novavax-COVAX and Pfizer-BioNTech

February 20, 2021 1:38 AM UTC

A week ahead of FDA’s Vaccines and Related Biological Products Advisory Committee meeting to discuss COVID-19 Vaccine Janssen from Johnson & Johnson (NYSE:JNJ), the pharma announced it submitted an application to the WHO for emergency use listing of the adenoviral vaccine.

The application is based on data from the Phase III ENSEMBLE trial that showed a one-shot regimen was 57-72% effective in South Africa, Latin America and the US. An emergency use listing from the WHO is a prerequisite to supply vaccines to lower income countries through the COVAX Facility. ...