Bharat Biotech’s COVID-19 vaccine has shown 80.6% efficacy in interim data from Phase III clinical trials, slightly better than the 79.3% reported by Sinopharm and significantly higher than Sinovac’s 50.6% for their vaccines based on similar technology. Supply deals are already on the way, with Brazil having signed up for 200 million doses.

The Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices concerns about making COVID-19 vaccine dose regimen changes based on unproven immune correlates of protection could be a warning sign to sponsors about roadblocks they might face if updating vaccines to address viral variants or conducting pediatric studies relying on such surrogate endpoints.

J&J CEO Gorsky says the agency is working with sponsors to ensure the proper data is gathered to make the vaccine available in children.

Agency’s unusual public statement about an investigational product's development status may be aimed at countering bullish comments from the sponsor; FDA cites failure of pivotal trial on the primary and secondary endpoints and ‘modest excess in deaths’ with the cell therapy.