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Operation Warp Speed has moved along at a rapid clip. But some people involved in the process fear pressure to deliver an October surprise for President Trump.
In April, with hospitals overwhelmed and much of the United States in lockdown, the Department of Health and Human Services produced a presentation for the White House arguing that rapid development of a coronavirus vaccine was the best hope to control the pandemic.
“DEADLINE: Enable broad access to the public by October 2020,” the first slide read, with the date in bold.
Given that it typically takes years to develop a vaccine, the timetable for the initiative, called Operation Warp Speed, was incredibly ambitious. With tens of thousands dying and tens of millions out of work, the crisis demanded an all-out public-private response, with the government supplying billions of dollars to pharmaceutical and biotechnology companies, providing logistical support and cutting through red tape.
It escaped no one that the proposed deadline also intersected nicely with President Trump’s need to curb the virus before the election in November.
The ensuing race for a vaccine — in the middle of a campaign in which the president’s handling of the pandemic is the key issue after he has spent his time in office undermining science and the expertise of the federal bureaucracy — is now testing the system set up to ensure safe and effective drugs to a degree never before seen.
Under constant pressure from a White House anxious for good news and a public desperate for a silver bullet to end the crisis, the government’s researchers are fearful of political intervention in the coming months and are struggling to ensure that the government maintains the right balance between speed and rigorous regulation, according to interviews with administration officials, federal scientists and outside experts.
Even in a less politically charged environment, there would be a fraught debate about how much to accelerate the process of trials and approval. The longer that vaccines are tested before being released, the likelier they are to be safe and effective.
But with 1,000 people dying each day in the United States, schools finding it difficult to reopen and the deep recession inflicting economic pain across the country, the desire to find a way to return to normal life is powerful and transcends partisan politics and borders. On Sunday, Russia announced that it planned to start a nationwide inoculation campaign in October with a vaccine that had yet to complete clinical trials, the latest evidence of the global potential for cutting corners.
Despite concerted efforts by the Trump administration and a bevy of pharmaceutical companies it is working with, the original October target has slipped, with the administration now pushing to have hundreds of millions of doses available by the end of the year or early 2021.
But experts inside and outside the government still say they fear the White House will push the Food and Drug Administration to overlook insufficient data and give at least limited emergency approval to a vaccine, perhaps for use by specific groups like front-line health care workers, before the vote on Nov. 3.
“There are a lot of people on the inside of this process who are very nervous about whether the administration is going to reach their hand into the Warp Speed bucket, pull out one or two or three vaccines, and say, ‘We’ve tested it on a few thousand people, it looks safe, and now we are going to roll it out,’” said Dr. Paul A. Offit of the University of Pennsylvania, who is a member of the Food and Drug Administration’s vaccine advisory committee.
“They are really worried about that,” he added. “And they should be.”
Mr. Trump relentlessly touts progress toward a vaccine, raising hopes of quick approval. Touring a North Carolina biotechnology lab last week, he vowed to “deliver a vaccine in record time.” In a tweet last month, he explicitly tied vaccines to his re-election hopes.
On a campaign call with supporters in Pennsylvania on Sunday evening, Mr. Trump said the “F.D.A. has been great, at my instruction,” and he again raised hopes of rapid progress.
