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Operation Warp Speed: U.S. government describes “unprecedented progress” in developing the COVID-19 vaccine 

COVID19

Posted: Friday, October 23, 2020. 2:48 pm CST.

By Aaron Humes: As its name suggests, Operation Warp Speed has brought together a joint set of U.S. government agencies to develop a COVID-19 vaccine in record time – a demand made particularly by President Donald Trump. 

The group of the U.S. Department of Health & Human Services (HHS); U.S. Defense Department, HHS, other federal agencies and private industry has made unprecedented progress and is pleased with where they are at present, according to HHS policy deputy chief of staff Paul Mango via Caribbeannews.net. 

Four of the six vaccine candidates are in phase III clinical trials, and the Food and Drug Administration continues to review vaccine safety information on the candidates, said Mango: “…we are already manufacturing at industrial scale…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, with many outlets being engaged – between 65 and 75 thousand – and tests are underway of the information technology system of the Centers for Disease Control and Prevention (CDC). 

More than 40 million kits have been assembled to house the vaccines, which are in warehouses, ready to go, Mango said, adding that the undertaking was a large-scale logistical task that’s also going well. 

Dr. Janet Woodcock, the director of the centers for drug evaluation research at the Food and Drug Administration, 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,” Woodcock said. “We’re also, of course, looking at a whole range of other interventions to manage complications of the infection.” 

She said the team feels as though the early indications of antiviral activity and potential impact on the clinical course of the disease are 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 the implementation of safe and effective COVID-19 vaccine programs,” Dr. Jay Butler, CDC deputy director for infectious diseases 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.” 

 

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