COVID-19 Vaccine Could Have 80-90% Efficacy and Secure FDA EUA by Late November, Says Head of Operation Warp Speed

However, he expected the EUA filing three or four weeks after knowing that the COVID-19 vaccine was effective. The US government’s Operation Warp Speed aims to bring to market a set of vaccines and treatments with a target of delivering 300 million doses of a vaccine starting in January.

Speaking on the FDA’s new stricter guidance for EUA of COVID-19 vaccines, Slaoui said that the safety follow-up requirements would give reasonable sampling of most of the adverse events of the vaccines currently in trials. That, coupled with very strong active pharmacovigilance, upon introduction of the COVID-19 vaccines, would fully characterize their long-term safety. On the FDA’s condition that the COVID-19 vaccines must be at least 50% effective, Slaoui said that he would be very negatively surprised if it was closer to 50% and expected between 80% and 90% efficacy.

“We don’t want to miss a vaccine that has 50% efficacy, if that was to be the reality,” said Slaoui. “Because 50% efficacy in the setting of a pandemic may mean 500 deaths prevented every day - that’s quite relevant. But my expectation is really something between 80% and 90% efficacy. I would be very negatively surprised if it was closer to 50%. Everything we see, including the recent data by Lilly and Regeneron with monoclonal antibody transfer, suggested robust efficacy can be achieved.”