President Trump on Friday outlined a strikingly ambitious plan to have a COVID-19 vaccine approved by the FDA and starting to be deployed by year’s end.
Trump promised that the administration’s Operation Warp Speed would make a COVID-19 vaccine available for widespread use by year’s end and would accelerate the development of therapeutics and diagnostics.
He named Moncef Slaoui — the former head of GlaxoSmithKline’s vaccines department and a director of Moderna — to head up the effort, which would require trials of thousands of participants and the costly job of scaling up manufacturing operations for the production of hundreds of millions of doses.
Most experts, including the nation’s top medical experts, have cautioned that developing an effective COVID vaccine in 12 to 18 months would require everything to go exactly according to plan, which rarely happens in vaccine development.
Rick Bright, former director of Biomedical Advanced Research and Development Authority (BARDA), testified before Congress last week, arguing that developing a vaccine in that timeframe would not produce enough trial data to support full FDA approval.
Anthony Fauci, director of the NIH’s National Institutes for Allergies and Infectious Diseases, testified before the Senate last week that a vaccine could possibly be ready within “a year or two”.
Former FDA Commissioner Scott Gottlieb predicted in March that a vaccine for COVID-19 would likely take two years.
The administration has identified 14 lead vaccine candidates and Trump said it plans to accelerate manufacturing capabilities so that it can deliver a vaccine in the very ambitious timeframe.
HHS Secretary Alex Azar said the administration is working toward a fully FDA-approved vaccine by year’s end, but that it plans to use all regulatory tools, such as an Emergency Use Authorization, to clear a vaccine by January.
Four-star Army Gen. Gustave Perna will oversee Operation Warp Speed as chief operating officer, while Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research (CBER), will oversee vaccine development and Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research (CDER), will head the therapeutics portion.
Bruce Tromberg, director of the National Institute of Biomedical Imaging and Bioengineering at the National Institutes of Health, will oversee diagnostics, the president announced.