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

COVID-19 vaccine makers could file for emergency authorization with the Food and Drug Administration by late November, immunization of high-risk populations could start by this year, and the vaccines could be more effective in clinical trials than previously assumed.

In an interview with MarketWatch, Moncef Slaoui who is running the Trump administration’s Operation Warp Speed program to spur the development of COVID-19 vaccines said that they would know if a vaccine works by late October, or November, or in December. 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.”