(2020-10-19) One Doctor's Campaign To Stop A Covid-19 Vaccine Being Rushed Through Before Election Day

One doctor’s campaign to stop a covid-19 vaccine being rushed through before Election Day. Topol, who works at the Scripps Research Institute in La Jolla and is one of the country’s most prominent doctors, aimed to prevent Trump from greenlighting a vaccine before scientists could prove it to be safe and effective. To Topol, developing an effective vaccine against covid-19 is “the biggest event in our generation” and one that should be evaluated on the basis of scientific data, not political implications.

By that point (Oct05) Eric Topol, a heart expert and researcher with a huge Twitter following of his own, was already weeks into a personal campaign to make sure the administration could not rush a covid-19 vaccine through regulatory authorization before Election Day on November 3.

Topol, who works at the Scripps Research Institute in La Jolla and is one of the country’s most prominent doctors, aimed to prevent Trump from greenlighting a vaccine before scientists could prove it to be safe and effective. To Topol, developing an effective vaccine against covid-19 is “the biggest event in our generation” and one that should be evaluated on the basis of scientific data, not political implications.

If Donald Trump badgered the US Food and Drug Administration into prematurely releasing a vaccine that wasn’t effective, or even caused harm, it could shake the public’s trust in any covid-19 vaccine. And if we are to achieve wide immunity against SARS-CoV-2, we'll need to vaccinate more people than the number that get flu shots each year. Releasing a vaccine that people are afraid of could do more harm than good.

To prevent such a scenario, Topol led online calls for FDA commissioner Steve Hahn to resign after his agency was criticized for cowing to political pressure—and then phoned Hahn a number of times to urge him to resist Trump’s influence

• We were on a path for a vaccine emergency authorization (EUA) before November 3rd. Thanks to the FDA, Trump's plan was disrupted.
  Eric Topol (@EricTopol) October 10, 2020

Evaluating a new drug or vaccine is typically a long process. But after the 9/11 attacks, Congress introduced a fast-track option called “emergency use authorization.”

The flexible process also allows political decision makers to take control as they did in August, when the FDA announced an EUA for convalescent plasma therapy (pdf), a treatment involving blood serum donated by covid-19 survivors

What alarmed Topol and other critics is that Hahn played along and badly misrepresented the facts, saying plasma transfusions would save 35 out of 100 covid-19 patients. In reality, no evidence for that claim existed. The therapy’s benefit remained uncertain

“That was the moment I decided, it’s time to become an activist,” says Topol. “I got very upset. I said he should resign or tell the truth. There was just this complete subservience to Trump.”

Topol began loudly calling on Hahn to confess or step down. Others joined the campaign

To stop rush authorization of a vaccine before the election, Topol also began working on another front.

Pfizer—never joined the federal program and has been running ahead of the companies that did. Its CEO, Bourla, had boldly said for months that its study of a genetic vaccine would have early efficacy results in October.

On September 25, Topol joined 60 other experts in sending a letter to Pfizer’s CEO, asking that the company not apply for an EUA before late November, when there would be more safety data.

“I don’t think that EUA is a bad idea. To me the question is, how good is the evidence?” says Alison Bateman-House, a professor and health policy researcher at NYU Langone Medical Center

Though Trump had accused “deep state” players at the FDA of delaying the approval of plasma therapy, the connections between doctors, drug companies, and health agencies run even deeper than he probably realized. All are heavily invested in evidence-based drug approval

The White House had been holding up publication of an FDA recommendation that companies developing any covid-19 vaccine should search for side effects for at least two months in half their trial patients. If that guideline were followed, it would make an EUA in October essentially impossible, even for Pfizer.

On the same day of Trump’s discharge, the FDA transmitted its recommendation to a key vaccine advisory committee, in what outside observers viewed as an end run past the White House

A week later, on Friday, October 16, Pfizer—citing the FDA recommendations—finally said it would not seek an EUA until after the election, even if the company thought its vaccine was working.

So, was this good because it reduced odds of Trump being re-elected? Or bad because it killed thousands of people by delaying vaccinations, setting too high a bar for safety during a pandemic?