Notably, companies that receive Operation Warp Speed support will have to commit to provide a donated allocation of their therapy to the U.S., HHS said in a statement. government will deploy every plane, truck, and soldier needed to help distribute it to Americans," he said Friday. military would also play a role in the distribution of any vaccine successfully developed. backing, readying manufacturing for year-end distribution will be extremely challenging - a "Herculean" task, Parna said. Operation Warp Speed will add to those efforts and help with producing and procuring the many items that go into a ready-to-use vaccine, like glass vials and syringes.Įven with the U.S. government is already funding manufacturing build-outs by private drugmakers through grants given by the Biomedical Advanced Research and Development Authority. Manufacturing any vaccine will be an enormous, and costly, undertaking - something Operation Warp Speed is meant to specifically address by supporting efforts to start producing doses before testing is completed.
OPERATION WARP SPEED VACCINES TRIAL
Moderna recently said its planned mid-stage trial was cleared by regulators to begin, and the company hopes to start Phase 3 testing by the summer.Įven if testing shows one vaccine to be promising enough to distribute on an emergency basis, regulators and scientists will likely know much less than usual about how well it works and whether it's fully safe for broad use across different population groups. More than a half dozen vaccine candidates for SARS-CoV-2, which has sickened more than 4 million people worldwide, are now in clinical study. Most vaccines require many years, sometimes more than a decade, for trials to show they are safe and effective. The fastest timeline for developing a vaccine is considered to be four years, for a mumps vaccine approved by the Food and Drug Administration in 1967. Moderna, a Cambridge, Massachusetts-based biotech that was first to launch human studies of a coronavirus vaccine candidate in the U.S., needed just two months to go from studying the virus' genetic sequence to dosing the first patient in a Phase 1 study.īy contrast, 20 months passed between identification of the SARS virus and first human testing. "I have very recently seen early data from a clinical trial with a coronavirus vaccine," Slaoui said Friday, "and these data made me even more confident that we will be able to deliver a few hundred million doses by the end of the year." He did not specify which vaccine he was discussing.Īcross the globe, drugmakers have designed and built vaccine prototypes for the new coronavirus with unprecedented speed. Slaoui, the new face of Operation Warp Speed, was bullish on the president's hope for a vaccine by year-end. That would on pace with, or even faster, than the best-case scenario of 12 to 18 months which Fauci has repeatedly set out as an objective. "We'd love to see if we could do it before the end of the year," the president said Friday at the Rose Garden, flanked by the heads of the health and defense departments, as well as Anthony Fauci, the U.S.'s top infectious diseases expert, and National Institutes of Health director Francis Collins.Ī formal announcement from the Department of Health and Human Services set January 2021 as the goal for making " substantial quantities of a safe and effective vaccine available for Americans." scientists, the military and private drugmakers can accomplish something never before achieved: a safe and effective vaccine available in just one year. Pitching Operation Warp Speed as a modern-day Manhattan Project, Trump is betting that, together, U.S.
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