Corrected, June 17. | The Trump administration is pushing for a coronavirus vaccine to protect some Americans by January 2021, but researchers and Democratic lawmakers are concerned about outside pressure on the complex process.
The initiative, known as Operation Warp Speed, is an effort by the departments of Defense and Health and Human Services to develop vaccines and drugs, fueled by at least $10 billion Congress provided for that purpose under the roughly $2 trillion March coronavirus relief package (PL 116-136).
A list of vaccine candidates will be winnowed from 14 to seven that will advance to early clinical trials in the coming weeks, senior administration officials said during a background briefing with reporters Tuesday. Three to five candidates will then benefit from hundreds of millions in taxpayer spending on new U.S. pharmaceutical plants to manufacture and distribute them.
A supply of any vaccine or medicine that receives millions in taxpayer aid will be available to the U.S. government, officials said. Some of this public supply will be made available for free to anyone who wants a vaccine and cannot afford it, they said.
Officials said the vaccine could be made available through a tiered system, with vulnerable older Americans, people with preexisting conditions, people performing “essential services” and the military receiving priority. But they cautioned that will ultimately depend on the safety data coming out of the clinical trials.
At least 116,210 Americans have died of COVID-19, and 437,152 people around the world have died, according to The New York Times.
But details were scarce about how the administration will reach the critical decision about which vaccines should be made by U.S. facilities. One administration official hinted it would depend in part on the ability of the company to quickly produce millions of doses by next year.
In order to make a vaccine available as soon as possible, scientists with the Pentagon will make data available to the Food and Drug Administration about clinical trials on a rolling basis instead of after the trial is completed. Vaccine manufacturing will advance even before vaccines win FDA approval, officials said.
Administration officials have made it clear that the president wants a vaccine available as soon as possible.
“President Trump looked at the timelines that all of these players in the pharmaceutical industry and elsewhere said would be needed to bring these products to market and he said, ‘That’s not acceptable,’” said HHS Secretary Alex Azar in a video promoting the effort.
But some researchers worry the science could be manipulated or misrepresented for political aims.
“Two weeks before the election, we’ll hear there’s an effective vaccine,” predicted Carlos del Rio, a professor at the Emory Vaccine Center, in an interview with the Journal of the American Medical Association Monday.
“There’s somebody who needs to be reelected who will rely on saying, ‘We got you an effective vaccine,’” he continued. “I don’t know what they’re going to do with the data, but I’m really concerned we’re going to have a not-very-effective vaccine that’s going to be touted like this success of the world.”
Concerns of congressional Democrats have flared about undue industry influence on multimillion-dollar contracts because of ties between a senior HHS official and Emergent BioSolutions, the company tapped to build U.S. factories. HHS officials have said the multimillion-dollar contracts awarded to several drugmakers for vaccine development — AstraZeneca, Moderna, and Johnson & Johnson — also includes funding to boost their private manufacturing capacity.
Who gets vaccines or treatments?
Pharmaceutical executives on a separate call with reporters Tuesday also stressed the importance of increasing U.S. manufacturing capacity to make sure everyone can get a drug or vaccine and said they are taking financial risks to do so.
“We want to make sure there aren’t difficult tradeoff decisions because demand far exceeds supply,” said Alexander Hardy, CEO of Genentech.
Significant questions about the availability of an eventual vaccine remain unresolved.
While COVID-19 spreads easily and quickly across borders, senior administration officials said there are no plans to distribute an eventual COVID-19 vaccine to other countries unless there is a surplus. However, nothing in U.S. contracts would inhibit drugmakers from working with other countries, officials said.
The U.S. is buying licensing rights to distribute the vaccines. The cost to the U.S. of any vaccine developed with millions in public research and development will be "amortized," an official said. But the terms of these contracts have not yet been made public.
Once vaccines or treatments are shown to be safe and effective, another question is how much they will cost.
Eli Lilly & Co. Chief Executive Officer David Ricks said on the call organized by the pharmaceutical industry trade group Pharmaceutical Research and Manufacturers of America that the pricing of therapeutics and vaccines will vary.
“It’s a challenging topic for industry,” Ricks said.
With a vaccine, “we have to give the medicine to people not just with the disease but people without the disease, which is in the billions scale across the planet,” he said. “That’s quite different from the therapies which are being repurposed."
For example, the population of patients needing anti-inflammatory therapies is in the range of thousands, not billions.
"That’s a much smaller population and a much sicker population," Ricks said. "Those have different considerations. It’s difficult to generalize.”
Dexamethasone, an anti-inflammatory steroid, reduced deaths in COVID-19 patients on ventilators by one-third in a clinical trial, researchers with the University of Oxford's RECOVERY trial said Tuesday. A full paper has not been published yet.
A 10-day supply of dexamethasone costs about $92.05 in the U.S., according to GoodRx.
Patient advocates and some lawmakers are pressuring the industry to make life-sustaining drugs and vaccines affordable.
“I’ll be damned if when a COVID-19 vaccine is developed, more people die because they can’t afford to purchase it,” Sen. Bernie Sanders, I-Vt., said in a viral tweet Tuesday. “Any life-saving vaccine must be free.”
Correction: This report was revised to correctly attribute comments made by Eli Lilly & Co. Chief Executive Officer David Ricks. An earlier version attributed them to another speaker on the call.