Operation Warp Speed is on track for January, but prioritization is necessary, officials say

Senior officials working on Operation Warp Speed held a briefing on Thursday where they laid out how a future vaccine would be prioritized and when the public can expect it to be released.

Paul Mango, the Deputy Chief of Staff for Policy at the Department of Health and Human Services, had three main messages: The project is on track to meet its timeline goals; the department is "maximizing" the probability of having tens of millions of vaccines by January 2021; the regulatory standard against which a vaccine is judged will not be affected by the accelerated timeline. 

WHAT'S THE IMPACT? VACCINE PRIORITIZATION

Along with discussing the department's vaccine investments, senior officials also addressed how vaccine distribution will be prioritized. 

Dr. Francis Collins, the director of the National Institutes of Health, said that 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. 

"The plan here does include having tens of millions of doses ready to go, which is unlike anything that's been done before," said Collins. "But that won't be enough on day one for everybody in the United States. So we would want to prioritize those people at higher risk, who would, therefore, get the greatest benefit from being early immunized."

As far as costs are concerned, Mango said that the federal government will pay for the procurement and distribution of enough doses of a vaccine for every U.S. population. 

For the administration of the vaccine, Mango said there will be funds to pay for both Medicare and Medicaid members, as well as funds in the Provider Relief Fund for uninsured individuals. He also said that, through talks with commercial insurers, most of them have agreed to have zero copays for the administration of the vaccine.

"What we're hoping is that every American will not only get a free vaccine distributed to many different outlets, but also will not have to pay anything for the administration of that vaccine," Mango said. 

WHAT'S THE IMPACT? VACCINE TIMELINE

Although the ultimate goal of Operation Warp Speed is to get a vaccine out by January 2021, there have been some estimations that a vaccine could be out as early as October 2020. 

The possibility of a vaccine being ready by then would take a "miracle," according to Collins. 

"The only way I could imagine that [a vaccine would be ready] is if, in fact, one of the Phase 3 trials that are now underway, enrolled at just absolute record speed, turned out to be 100% effective," he said. "I would not expect to see, on the basis of what we know scientifically, that we'd be at the point where FDA would have the chance to make such a judgment until considerably later than October 1."

At the earliest, Collins said a vaccine could be ready by November or December. 

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.

The project plans to accomplish its goal by investing in vaccine manufacturing. Most recently, HHS and DoD invested $1.5 billion into Moderna to manufacture and deliver 100 million doses of the company's COVID-19 vaccine candidate.

"Making up-front investments in manufacturing and mitigating much of these financial risks for the companies is key to maximizing the probability, as I said previously, that we'll have a safe and effective vaccine to start distributing no later than January 2021," said Mango. "This means making billions of dollars in investments with the promise of saving tens of thousands of lives and achieving a multitrillion dollar return."

In addition to that investment, the federal government has deals with Johnson & Johnson, Pfizer, Novavax, AstraZeneca, and Sanofi and GlaxoSmithKline for their respective vaccine candidates. 

ON THE RECORD

"We are achieving our key timing milestones," Mango said. "Everyone involved in Operation Warp Speed [has] much about which to be proud of thus far – from our public health experts and scientists to our private-sector partners and everyone who has laid the groundwork for this project."

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