- The Washington Times - Wednesday, April 29, 2020

Big Pharma’s race to blunt the coronavirus pandemic is heating up, with drugmakers pushing to provide millions of vaccine doses by the end of this year and trials of a drug treatment from Gilead Sciences billowing “positive” smoke signals Wednesday.

A government study found Gilead’s antiviral, remdesivir, had a clear effect in cutting the time patients need to recover, said Dr. Anthony Fauci, who directs infectious-disease research at the National Institutes of Health.

Remdesivir improved recovery time from 15 days to 11 days.

Even if that “doesn’t seem like a knockout 100%, it is a very important proof of concept,” Dr. Fauci said at a White House meeting with President Trump and Louisiana Gov. John Bel Edwards. “Because what it has proven is that a drug can block this virus.”

Dr. Fauci said in a trial involving more than 1,000 patients, there was a lower mortality rate in the group who took remdesivir, at 8%, versus over 11% in the placebo group. He said the drug isn’t a sure thing — the results must be peer-reviewed — but it shows real promise.



Dr. Fauci said the administration decided to tout the early results because people in the placebo deserve to access the drug.

“All of the trials that are taking place now have a new standard of care,” he said.

The Food and Drug Administration said it is engaged in “sustained and ongoing discussions with Gilead Sciences regarding making remdesivir available to patients as quickly as possible, as appropriate.”

Asked if the FDA should approve it for emergency use, Mr. Trump said: “We would like to see very swift approvals, especially with things that work.”

Gilead, based in California, said it was aware of the positive data but said the drug is “not yet licensed or approved anywhere globally and has not yet been demonstrated to be safe or effective for the treatment of COVID-19.”

It’s the latest twist in the race to develop a pharmaceutical defense to the COVID-19 pandemic that began Wuhan, China, in December and has swept across the globe. More than 1 million people have been infected in the U.S., killing over 60,000.

With no vaccine or proven cure, Americans have been forced to close their businesses and hunker down at home in a form of social distancing designed to disrupt transmission. States are easing off stay-at-home restrictions to reopen their economies, but the lack of treatments or vaccines means they’re risking new waves of infection.

“It’s a beginning, it means you build on it,” Mr. Trump said of the remdesivir news. “Certainly, it’s a positive, it’s a very positive event … We’re gonna be very careful as we open.”

Pharmaceutical companies and university researchers have responded to the pandemic with unusual vigor, given the public pressure to get people out of their homes and generous offers of government assistance to get products to market.

“I think there are 70 companies that are preparing creative vaccines against this coronavirus,” said Barry Bloom, a research professor at the Harvard T.H. Chan School of Public Health. “What will be limiting is not the imagination or the ability of genetic engineering. It’s who has the capacity to produce, at a global-scale level, billions of doses if in the initial studies, it’s shown to be safe and effective.”

Pfizer said it is optimistic about its ability to get its messenger RNA vaccine shots into arms by the end of the year, as it partners with German company BioNTech.

“The companies estimate that there is potential to supply millions of vaccine doses by the end of 2020, subject to technical success of the development program and approval by regulatory authorities, and the potential to rapidly scale up the capacity to produce hundreds of millions of doses in 2021,” the company told investors this week.

Moderna Inc. is working to set up a phase-2 trial of its messenger RNA vaccine involving 600 people. It should begin soon, and it is eyeing a phase-3 trial by the fall.

Johnson and Johnson said it is prepping its vaccine-production facility in Leiden, the Netherlands, to support human trials by the fall and get authorization for emergency use of its shots by early 2021.

Oxford University in the United Kingdom may be the global leader. It has progressed to human trials, which may conclude by September, and the developers are working with the Serum Institute of India to produce 60 million doses by this year, according to Reuters.

“We’re gonna have a lot of shots on goal when it comes to vaccines,” Dr. Fauci said.

Bloomberg News said the Trump administration is organizing a new campaign, dubbed “Operation Warp Speed,” to grease the path toward a vaccine through greater collaboration between government and the individual companies, with taxpayers shouldering the burden if any of them fail. The idea is to have 300 million doses of vaccine by January.

“Operation Warp Speed is clearly another extension of the President Trump’s bold leadership and unwillingness to accept ‘business as usual’ approaches to addressing the COVID-19 crisis,” Department of Health and Human Services spokesman Michael Caputo said.

Scientists said trial vaccines may be used to protect frontline workers or people in nursing homes this year, which will add to the scientific record and may help companies get their products authorized for emergency use.

“We might see stuff in people before Tony Fauci’s famous 18 months,” Dr. Bloom said, referring to the doctor’s early warning it could take a year and a half to see a COVID-19 vaccine. “Whether we’ll have real information on their effectiveness and comparative effectiveness — I don’t think we’re gonna have that easily before 18 months or two years.”

Mr. Trump, who faces reelection in the fall, is eager to see a therapy in the coming weeks or months to end the pandemic faster and get the economy revving again, even if a vaccine is the most complete defense against the virus.

Remdesivir, which is delivered intravenously, has been touted for weeks as a leading contender for treating the coronavirus.

Gilead said its own trial found that patients treated with remdesivir within 10 days of developing signs of the disease had better outcomes than those treated after 10 days of symptoms. It said 62% of patients treated early with were able to be discharged from the hospital during the analysis, compared to 49% of those treated late.

Gilead shares rose almost 6% Wednesday after reporting the results, which also found that patients who received a five-day dosing showed similar results to those receiving a 10-day course.

“The study demonstrates the potential for some patients to be treated with a five-day regimen, which could significantly expand the number of patients who could be treated with our current supply of remdesivir,” said Merdad Parsey, the company’s chief medical officer. “This is particularly important in the setting of a pandemic, to help hospitals and healthcare workers treat more patients in urgent need of care.”

Former FDA Commissioner Scott Gottlieb told CNBC ‘s “Squawk Box” that remdesivir should be viewed as a useful tool in the fight but “not a home run, a cure by any means.”

It could be something that, if used early, “it could reduce their chances of having a really bad outcome,” he said.

Dr. Gottlieb, who is among 200 industry leaders and experts advising the White House on the virus, said it could be close to two years before there is widespread vaccination in the U.S.

“I don’t know the exact manufacturing timeline for these different companies, but it’s definitely well into 2021 in terms of a vaccine available in the hundreds of millions of doses that you would need to mass inoculate a population,” said Dr. Gottlieb, who led the FDA earlier in Mr. Trump’s term.

Companies racing to beat the odds are taking on a big risk.

There’s often little financial upside to developing products for outbreaks that come and go — sometimes before the drugs and vaccines can be fully tested. Plus, ramping up production costs money.

“We should be very grateful for the companies that are now committing themselves to moving forward with this vaccine,” Dr. Bloom said, “which on a global level strikes me as not likely to be a big money-winner.”

• David Sherfinski contributed to this report.

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