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Vaccine by Election Day Will Be More Difficult as FDA Will Announce Tougher New Standards

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Vaccine by Election Day Will Be More Difficult as FDA Will Announce Tougher New Standards

2020-09-23 17:08:11

By Laura Tucker, Staff writer; Image: Vaccine being administered (Image source: Public domain)

The coronavirus vaccine won't do any good if the majority of the population don't take it when it's available. Yet, because of Donald Trump's comments, there is a growing distrust in the vaccine. This has led the Food and Drug Administration to consider tougher standards to increase the likelihood of it being seen as safe.

The FDA is expected to announce a stricter standard for an emergency authorization of a coronavirus vaccine. That new standard could be announced as soon as this week, with the knowledge that it will make it that much more difficult for it to be available by Election Day, as the president has promised.

The purpose of this new guidance is to increase transparency and public trust as it gets closer to ultimately deciding whether a prospective vaccine is effective or even safe. Public health experts have concerns that Trump's predictions for a vaccine by the end of October and his administration interfering with federal health agencies may lead to the public refusing to get the vaccine, believing it was too rushed.

That's the hazards of politics entering into the health realm. The Pew Research Center showed in a recent poll that the percentage of people willing to get a vaccine if it were offered today has dropped from 72 in May to now just over 50.

It's notable that the criteria for the vaccine is a more thorough process than was given to the clearance for hydroxychloroquine. It was rushed through, only for it to later be shown as ineffective and even leading to sooner deaths for some.

The FDA would have manufacturers asking for the emergency authorization to follow the participants in the late-stage clinic trials for at least two months after they receive a second dose of the vaccine, according to people familiar with the matter.

The agency is likely to look for the vaccine to be 50 percent more effective than a placebo. That, along with the time it will take for manufacturers to prepare applications and for the agency to review the data, lead to an improbability a vaccine could possibly be authorized before November 3.

"It's hard to imagine how an [emergency use authorization] could possibly occur before December," said Paul Offit, the director of the Vaccine Education Center at Children's Hospital of Philadelphia and a member of the FDA's advisory board on vaccines.

Trials by Moderna and Pfizer were started on July 27. Fifteen thousand people enrolled within a month, making the trial halfway to the planned 30,000 total enrollment. Those participating in the trial were supposed to receive their second dose three or four weeks later. With two months of follow-up after the trial, it's unlikely there would be enough data by midway through November.

Along with the new guidance, career scientists at the agency are going to have a spotlight placed on them as well. The scientist that oversees the approval process for vaccines has threatened to quit if he is pressured to recommend the vaccine before he is assured it's safe and effective.

However, throughout all this, Trump, desperate to win reelection, continues to override all these efforts and make comments that diminish the public's trust in the government scientists.

"Things are so revved up right now that there is quite a possibility that the American public won't accept a vaccine because of all the things that are going on," said Peter Hotez, the dean of the National School of Tropical Medicine at Baylor College of Medicine. "U.S. history is littered with good vaccines that get voted off the island because of bad public perceptions."

Last week, Health and Human Services Secretary Alex Azar revoked the authority of the FDA and other agencies to sign new regulations. Only he will be able to do so moving forward.

The HHS issued a statement on Sunday that said the change "minimizes litigation risk ... prevents potential future abuse of authority, and is consistent with congressional intent." It added that this wouldn't affect the FDA's work on vaccines.

"Why take this health decision-making away from public health agencies like FDA at this particular moment?" asked Patricia Zettler, an Ohio State University law professor and former associate chief counsel at the FDA.

There were also efforts by a top HHS appointee and his adviser to keep a Centers for Disease Control and Prevention official quiet after the seriousness of the virus was mentioned. It was noted that there were attempts to change and delay the Morbidity and Mortality Weekly Reports if they strayed too much from Trump's messages.

Along with all of this, the CDC posted and then quickly removed wording on its website that said the virus is spread via airborne transmissions. It led to questions of why it would retract its guidance.

Pfizer issued a statement on Tuesday that said it is still projecting to have data on the effectiveness of its vaccine at the end of October. If it goes well, it will collect safety data for two years. Moderna is unlikely to have data in October. AstraZeneca's U.S. trial is on hold while investigators look into the neurological problem of one study participant in Britain.

A Washington University at St. Louis law professor, Rachel Sachs, said there are concerns that Azar, who has the authority to approve drugs, would overrule the FDA if it rejects a vaccine. She believes that scenario is unlikely.

Azar's chief of staff, Brian Harrison, said the idea his boss would do that was "preposterous and betrays ignorance of the transparent process" the administration is following with the vaccines.

"If we don't get this right, we'll see a deep corrosion of trust over the long term — and that will be the darkest legacy for a post-COVID world," said Georgetown University law school public health expert, Lawrence Gostin.

Eric Topol, the founder and director of Scripps Research Translational Institute, agrees. "We are not in a high-trust mode, and the last thing you want to do is take a shortcut and put everything at risk," he said. He doesn't believe an authorization should be considered until early next year to be sure there is enough safety data. 

Yet, Robert Califf, an Obama-era FDA commissioner, said, "If there is definitive evidence of efficacy and no significant signal of toxicity or lack of safety, withholding authorization would be an equal sin on the other side."

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