BioCentury
ARTICLE | Regulation

After speedy approval on immunogenicity data, Russia readies Phase III study of COVID-19 vaccine ‘Sputnik’

August 12, 2020 2:14 AM UTC

The Ministry of Health of the Russian Federation has approved a COVID-19 vaccine under emergency rules based on immunogenicity rather than protection data. 

While COVID-19 vaccine developers have been gathering safety and immune response data through Phase I and II trials at record speed during the pandemic, no one has yet to correlate antibody titers, virus-specific T cells or other immune markers with actual protection in humans -- the highest hurdle to clear. ...