The Food and Drug Administration has altered the requirements for fast-track approval of a coronavirus vaccine. Now, a company must provide two months of follow-up data on those given the vaccine to make sure there are no serious side effects and prove the vaccine’s effectiveness.
Ordinarily, the follow-up to human trials for a new vaccine lasts a year or more, as companies carefully compile data on the serum’s effectiveness and possible side effects. The approval process is usually laborious and time-consuming. The caution is well-founded. A vaccine is going to be administered to tens of millions of people and every effort should be made to make sure the vaccine works as advertised and is safe.
Except in a public health emergency. Then, the FDA is granted extraordinary discretion in approving new drugs and vaccines to deal with the crisis.
An extraordinary effort has been underway since March of this year involving industry and government in an unprecedented partnership to develop a vaccine in record time. Named “Operation Warp Speed,” pharmaceutical companies—funded by a mix of public and private money—have developed seven candidate vaccines that are in various stages of final testing. It may have been possible for a vaccine to be approved before Election Day with the FDA’s “fast track” rules.
But something happened on the way to salvation: Democrats realized that the Trump campaign for re-election would get a boost from the approval of any vaccine. So they employed their favorite tactics—fear and hysteria. They said you can’t trust a vaccine if Trump says it’s safe and effective because, well, Orange Man Bad. They shamed the FDA into slowing down the vaccine approval process just to make sure there will not be an approved vaccine before Election Day.
The Food and Drug Administration told makers of experimental COVID-19 vaccines that, in order to request emergency approval, they need to provide at least two months of follow-up data after trial participants received their final injection.
The new requirement – listed within the agency’s newly published guidelines for Emergency Use Authorization (EAU) – creates an unlikely timeline for drugmakers to receive approval by Nov. 3.
This is what the FDA chief said in August.
Insisting that the move would not be due to pressure from the Trump administration to fast track a vaccine, FDA Commissioner Dr. Stephen Hahn told the newspaper that an emergency authorization could be appropriate before phase three clinical trials are completed if the benefits outweigh the risks.
“It is up to the [vaccine developer] to apply for authorization or approval, and we make an adjudication of their application,” Hahn said. “If they do that before the end of phase three, we may find that appropriate. We may find that inappropriate, we will make a determination.”
The FDA was pilloried in the press for “politicizing” the vaccine approval process. Given that even with the fast-track approval process—there would be several boards and many individuals who would need to approve the serum before a final decision was made—it’s hard, if not impossible to see how Donald Trump could influence their decision. It’s idiotic to think that he could—which makes it easy for Democrats who are experts at scaring the pants off the public to achieve their political ends.
The new guidelines became necessary when polls showed a huge number of Americans won’t accept a vaccine if Trump approves it. How many people are going to die because Democrats are playing politics with the vaccine approval process?
However, a senior administration official confirmed Monday that the White House had blocked the FDA’s plans to formally publish the safety guidelines regarding the two-month data requirement, arguing there was “no clinical or medical reason” for it.
However, this didn’t stop the agency, which posted the guidance on its website a day later, making clear that regulators plan to impose the safety standards for any vaccine seeking an expedited path to market.
Donald Trump called the new regulations “a political hit job.” Is he right? Perhaps, but it’s not aimed at him specifically. Most federal agencies are shy about negative publicity and being called Trump toadies and sycophants obviously didn’t sit well with them.
The FDA is technically right about slowing down the vaccine approval process. But saying there was “no clinical or medical reason” for it is correct too.