Politics may compromise on safety of coronavirus vaccine, fear scientists

In April, with hospitals overwhelmed and much of the US 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 US President Donald 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 US, 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 (FDA) 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 November 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 Paul A Offit of the University of Pennsylvania, who is a member of the FDA’s vaccine advisory committee. “They are really worried about that,” he added. “And they should be.”

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, Trump said the “FDA has been great, at my instruction,” and he again raised hopes of rapid progress. “We expect to have a vaccine available very, very early before the end of the year, far ahead of schedule,” he said. “We’re very close to having that finalised.”

The president’s son-in-law and senior adviser, Jared Kushner, who is helping to steer the re-election campaign from the White House, is a regular participant in meetings of a board formed to oversee the vaccine effort.

While White House officials do not specifically mention the election during the board’s discussions, people familiar with the conversations say they ask regularly about October, a date that hangs over the effort. Trump campaign advisers privately call a pre-election vaccine “the holy grail.”

The FDA’s approval of a new vaccine is typically an exhaustive process, where agency employees meticulously go through data from clinical trials to review whether the vaccine is both safe and effective. The threshold for approving vaccines is typically higher than it is for therapeutic drugs because they will be used in millions of otherwise healthy people, meaning that even rare side effects could affect many more people than a drug that treats a specific illness.

An independent advisory panel of outside experts also weighs in, and while the agency has the power to make its own decision, it typically follows the advice of its outside panels. The FDA’s senior regulator has the power to approve or deny vaccines for emergency use, but that decision could be overridden by the agency’s top leaders, or by the secretary of health and human services.

White House officials said that Trump would not distort the vaccine review process to help his campaign. “The rapid research, development, trials and eventual distribution of a Covid-19 vaccine is emblematic of President Trump’s highest priority: the health and safety of the American people,” said Judd Deere, a White House spokesman. “It has nothing to do with politics.”

Anthony S Fauci, the director of the National Institute of Allergy and Infectious Diseases, told lawmakers on Friday that he remained “cautiously optimistic that we will have a vaccine by the end of this year and as we go into 2021.” Stephen Hahn, the commissioner of the FDA, has not ruled out emergency approval of a vaccine.

“We would consider using an emergency use authorisation if we felt that the risks associated with the vaccine were much lower than the risks of not having a vaccine,” he told the Journal of the American Medical Association in an online interview. He also said regulators would certify that any vaccine would meet the agency’s rigorous standards, adding, “My job as commissioner is to make sure to the fullest extent possible that any pressure that comes to the agency is not reflected downward” on to regulators and scientists studying the vaccines.

At the same time, a senior administration official refused to promise that any emergency approval of a vaccine would be vetted through the FDA’s outside advisory panel of experts, scheduled to meet on October 22. Operation Warp Speed got its start in April, the brainchild of Peter Marks, a pencil-thin, bespectacled physician who leads the regulatory unit at the FDA that approves vaccines and therapies.

A Star Trek fan, Marks named the initiative Warp Speed and pitched it in an April 10 phone call to Alex M Azar II, the secretary of health and human services, who quickly embraced it. In a follow-up phone call a few days later, according to a person familiar with the discussions, several health officials said the October deadline was unrealistic; over the next few months, officials began publicly citing the end of the year or early 2021 as a target. With his job on the line, Azar, the target of Trump’s wrath over the virus, was especially eager to prove his worth.

© New York Times News Service 2020