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Operation Warp Speed clinical trials have robust participation from diverse subjects, officials say

The project expects two more trials to enter phase three by mid-September, with results from the first trials expected between October and December.

Mallory Hackett, Associate Editor

Senior officials working on Operation Warp Speed said in a briefing Friday that they are past the halfway point in terms of enrollment for the two vaccine candidates from Moderna and Pfizer that are in phase three of their clinical trials.

The Food and Drug Administration has required that each of the trials enroll 30,000 participants.

Deputy Chief of Staff for Policy at the Department of Health and Human Services Paul Mango reported in the briefing that combined, the trials have over 30,000 diverse participants so far.

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"We have a very large number of folks over age 65. We have a lot of folks with multiple chronic conditions. We have Hispanic participation, we have African American participation," he said. "We are trying to advance some of the minority participation a little bit more, but we feel very good about those clinical trials."

Operation Warp Speed is expecting two more vaccine candidates to enter into phase three by the middle of September, with results from the first trials to be expected between October and December, according to Mango.

WHAT'S THE IMPACT? VACCINE TIMELINE

As for when the public can expect to see a vaccine hit the market, Mango said Operation Warp Speed is on track to have a COVID-19 vaccine by the end of the year, if not a little ahead of schedule.

The factors contributing to this include manufacturing the vaccine prior to approval from the FDA and covering the logistical details of distribution.

Earlier this month, the Centers for Disease Control and Prevention selected McKesson Corporation to support the distribution of COVID-19 vaccines and related supplies.

"The vast majority of our logistical needs are either already covered or underway," Mango said. "That's a very important part of overall warp speed because we don't want to have a safe and effective vaccine in large quantities and not have the ability to put it into the arms of tens of millions of Americans."

In fact, the only factor that is not certain for Operation Warp Speed is when the FDA will approve a vaccination, according to Mango.

"Indeed, we will have hundreds of millions of doses of vaccines available before year-end," he said. "What is uncertain is whether or not those will be FDA-approved. That's the uncertainty. We feel comfortable that we will have the vaccines manufactured, we are less certain about when they will be deemed safe and effective."

THE LARGER TREND

Operation Warp Speed was created to deliver 300 million doses of a COVID-19 vaccine by January 2021 by compressing what is normally a 73-month process of creating a safe and effective vaccine into 14 months.

It includes components of HHS, including the Centers for Disease Control and Prevention, the Food and Drug Administration, the National Institutes of Health, and the Biomedical Advanced Research and Development Authority. It also includes the departments of Defense, Agriculture, Energy and Veterans Affairs.

So far, Operation Warp Speed has deals with Moderna, Johnson & Johnson, Pfizer, Novavax, AstraZeneca, and Sanofi and GlaxoSmithKline to develop a potential vaccine.

In previous briefings, senior officials have stressed the need for distribution prioritization once a vaccine is approved. Those that will likely be first to get the vaccine are the elderly (especially those in nursing homes), healthcare workers and other high-risk individuals like those with chronic illnesses will be the first to get a vaccine.

Twitter: @HackettMallory
Email the writer: mhackett@himss.org