- The Washington Times - Thursday, August 6, 2020

President Trump said Thursday that a coronavirus vaccine is possible by Election Day, offering an optimistic timeline for a shot that could return life to normal in the U.S. while amplifying concerns that the unprecedented race could be tainted by election-year politics.

Scientists generally say that human trials are far enough along to produce a vaccine by the beginning of next year, though Mr. Trump is eyeing a speedier victory.

“Sooner than the end of the year, could be much sooner,” Mr. Trump told radio host Geraldo Rivera, who wanted to know the earliest delivery date.

“Sooner than Nov. 3?” Mr. Rivera said of Election Day.

“I think in some cases, yes — possible before, but right around that time,” Mr. Trump said. “The rest of the world is also doing vaccines, so let’s see how they do. I’m all for them, whoever comes up with one.”

He doubled down on his optimism as he departed the White House for a trip to Ohio.

“I am optimistic that it will be probably around that date,” Mr. Trump said of Nov. 3. “I believe we’ll have the vaccine before the end of the year, certainly, but around that date, yes, I think so.”

The Food and Drug Administration commissioner has repeatedly said he will not “cut corners” as the agency vets a series of promising candidates in the global race for a vaccine.

Scientists have gathered 30,000 people in three months for human trials, giving it the same statistical power as a trial over a longer period. Yet the short time frame — vaccine development usually takes years — won’t give researchers much time to check for adverse effects over the long term.

Given that backdrop, the scientific community is watching to see how carefully the FDA proceeds on a vaccine after it had to reverse its emergency-use authorization for hydroxychloroquine —a malaria drug pushed by Mr. Trump as a potential game-changer, despite a lack of data. The FDA also had to tighten its vetting of antibody tests that turned out to be flimsy, said Barry Bloom, a research professor at the Harvard T.H. Chan School of Public Health.

“So with 0-for-2 on those two major issues, there is reason for skepticism that there could be an October surprise and [that] without public data, without full analysis, the director of FDA could simply say, ‘It’s a bad problem. I give it emergency use and we’ll collect data,’” Dr. Bloom said. “That would really, I think, compromise what little trust we have [left] in this country about A, vaccines in general, and B, the government’s controlling or regulating vaccines to protect the public interest.”

Food and Drug Commissioner Stephen Hahn said his agency will not skip steps on a vaccine and that it is walled off from Operation Warp Speed, an administration effort to secure doses and the vials needed to administer the shots.

“We’ll ultimately be calling the balls and strikes with respect to the safety and efficacy of a vaccine,” Dr. Hahn said at a pubic roundtable last week. “We aren’t cutting corners with respect to the development, and we will not be cutting corners with respect to the assessment of the safety and efficacy of the vaccine.”

Dr. Hahn underscored those principles in a Washington Post op-ed Thursday, saying FDA decisions will be based on sound science, that vaccine development takes time and he has outlined clear principles for a successful candidate. For instance, the agency says an approved vaccine must show that it prevents the disease or decreases its severity in at least 50% of people who are vaccinated.

It’s hard to overstate the importance of a vaccine in combating the coronavirus, which has killed more than 700,000 worldwide, including nearly 159,000 in the U.S.

Countries and U.S. states have taken a series of drastic measures to keep people apart and slow transmission, resulting in economic downturns, though flare-ups occur regularly, partly because of lax behaviors and gaps in testing and tracing of the disease.

Underscoring the reach of the virus, Ohio Gov. Mike DeWine — a Republican who has won bipartisan praise for his handling of the virus response — tested positive for COVID-19 Thursday as part of a standard protocol to greet Mr. Trump at an airport in Cleveland, his office said.

He is asymptomatic and plans to quarantine at his home in Cedarville for two weeks. The governor’s office said Thursday night that Mr. DeWine tested negative in a follow-up test, as did his wife and several staffers.

Mr. DeWine is the second governor known to have tested positive for the coronavirus. Oklahoma Gov. Kevin Stitt, a Republican, announced a positive test last month.

The U.S. case count appears to be slowing, with a seven-day average of about 57,000 daily cases compared with more than 66,000 two weeks ago.

Some local officials are frustrated by persistent transmission, however, and are taking more drastic steps.

Los Angeles Mayor Eric Garcetti said he authorized the city’s Department of Water and Power to shut off utilities for households that host large parties in violation of a health order that prohibits gatherings during the pandemic.

Mr. Trump, meanwhile, tends to focus instead on drug therapies to help patients survive and the historic pace of the race for a vaccine.

Speaking in Ohio, he told Whirlpool factory workers that he hopes to land a vaccine “very soon. I hope well before the end of the year.”

Vice President Mike Pence, tasked by the president with leading the U.S. response to the virus, has echoed Mr. Trump’s push for a vaccine before the end of the year.

“In the first few weeks of February, we actually began the process of developing a vaccine,” Mr. Pence told Fox News this week. “And you just heard a week ago that we’re already at a historic pace, in phase three clinical trials of the first coronavirus vaccine for this country. Could well be available for this fall.”

More than 130 vaccines for the coronavirus are in development around the world, including six in phase three human trials.

The U.S. is securing hundreds of millions of doses ahead of time from companies such as Johnson & Johnson, Moderna and Pfizer, plus doses from British manufacturer AstraZeneca, which is working with Oxford University on a promising vaccine and is one of the front-runners for approval.

But Paul A. Offit, a pediatrics professor at the University of Pennsylvania and a member of the FDA’s vaccine advisory panel, said even under ideal circumstances, it’s hard to see how a vaccine would be ready to go before the end of the year.

Assembling 30,000 people for the first dose in August would be incredibly efficient, and the second dose brings the timeline to September, he said. Researchers must wait weeks for an immune response, bringing the timeline to October, and then wait further to see how many people in the placebo group get sick versus the vaccine group, likely bringing the process into the new year.

That timeline aligns with the early 2021 target that Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, has offered in public interviews and testimony.

Dr. Fauci told Reuters he has not seen any pressure to announce the delivery of a vaccine before the election.

The White House said the effort “has nothing to do with politics.”

“This president understands that this vaccine cannot get bogged down in government bureaucracy, which is why he has cut through every piece of red tape and launched an unprecedented public-private partnership to achieve the fastest-ever launch,” White House deputy press secretary Judd Deere said. “Any new vaccine must maintain FDA’s gold standard for safety and be thoroughly tested to ensure it is effective, which is why Operation Warp Speed is being led by expert scientists focused on saving lives.”

Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security, said that despite room for skepticism, there are guardrails on the process.

“There is always concern that [Mr. Trump] will try to inject politics into the process of responding to this pandemic, as he has from the very beginning,” he said. “However, it’s not just the FDA, but there are other regulatory agencies in Europe as well as professional societies that will play a role in evaluating the vaccine.”

Still, Mr. Trump has continued to up the ante, saying people can expect a vaccine “very soon.”

Asked whether landing a vaccine would help his election prospects against former Vice President Joseph R. Biden, Mr. Trump told White House reporters on Thursday that it “wouldn’t hurt.”

“I’m doing it not for the election. I want it fast because I want to save a lot of lives,” he said.

Mr. Biden has questioned the Trump administration’s ability to distribute the shots efficiently and equitably.

“If tomorrow, God willing, all of a sudden there was a vaccine, what do you think would happen?” Mr. Biden told supporters in late July. “He wouldn’t know what the hell to do with it. It would still get behind the curve.”

David Sherfinski contributed to this report.

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