Unprecedented progress has been made recently on Operation Warp Speed — the effort by the Defense Department, Health and Human Services, other federal agencies and private industry to develop a coronavirus vaccine, an HHS official said today.
In a telephone briefing with reporters, HHS policy deputy chief of staff Paul Mango said, "We're very, very pleased with where we are." He was joined on the media conference call by Dr. Janet Woodcock, M.D., the director of the centers for drug evaluation research at the Food and Drug Administration, and Dr. Jay Butler, the deputy director for infectious diseases at the Centers for Disease Control and Prevention.
Mango reminded reporters that four of the six vaccine candidates are in phase III clinical trials, and added that the Food and Drug Administration continues to review vaccine safety information on the candidates.
"For all of these vaccines — all six vaccine candidates — we are already manufacturing at industrial scale," he said, "Along the way, we've encountered the normal what I would say scientific obstacles that had to be overcome. We feel very good about having done that. And now we're just waiting particularly for those that are in phase III trials for the appropriate number of events to occur so that those vaccines can be evaluated by the FDA."
Progress has also been made on vaccine distribution plans, he said.
"We're in the process of actively engaging tens of thousands of provider outlets for these vaccines," Mango said. "We anticipate having collectively 65,000 [to] 75,000 points of potential vaccination. Our [information technology] system is knitting together a lot of the legacy systems that the CDC has had in place for a long time [and] we're testing that, stress testing it; we feel very good thus far about its capacity and its robustness."
More than 40-million kits have been assembled to house the vaccines, which are in warehouses, ready to go, Mango noted, adding that undertaking was a large-scale logistical task that's also going well.
Woodcock said two drug companies — Eli Lilly and Regeneron — recently announced they had completed study findings in outpatients. Both of the firms have publicly announced they have submitted emergency-use authorizations to the FDA based on early data, she said.
"In the meantime, we continue to study the Lilly antibody in both inpatients and outpatients in OWS-supported NIH active trials," she said. "We're also, of course, looking at a whole range of other interventions to manage complications of the infection."
Woodcock said the team feels as though the early indications of antiviral activity and potential impact on the clinical course of disease is very promising. "In the meantime, we continue to study these antibodies and we plan to study more of them in our master protocol."
"We've been preparing for implementation of safe and effective COVID-19 vaccine programs," Butler said. "Nationally, we believe it is a crucial next step as part of our overall efforts to protect Americans, reduce the impacts of the COVID-19 pandemic, and help restore some normalcy to our lives in our country."