The Trump administration is blocking the Food and Drug Administration from issuing new standards that any coronavirus vaccine candidate must meet in order to warrant emergency authorization. This latest episode in the White House’s head-in-sand approach to dealing with the pandemic is because new, more stringent guidelines aimed at ensure the vaccine’s safety and Americans’ trust would make it a virtual certainty that no vaccine will be able to be announced by Election Day—in just 28 days. The FDA submitted its guidelines for approval weeks ago, but they were railroaded by White House chief of staff Mark Meadows.
There are a number of pharmaceutical companies currently working to develop a vaccine, though only one—Pfizer—is even in the ballpark timing-wise of a Nov. 3 announcement, as the testing timelines are much longer for its competitors, Moderna, AstraZeneca, and Johnson & Johnson. Trump, it appears, has put all of his eggs in the Pfizer basket to announce some form of miracle cure in the next four weeks to try to resuscitate his reelection chances. And he doesn’t want to let the potential of an unsafe or ineffective vaccine get in the way.
“A main sticking point has been the recommendation that volunteers who have participated in vaccine clinical trials be followed for a median of two months after the final dose before any authorization is granted, according to a senior administration official and others familiar with the situation, who spoke on the condition of anonymity,” the New York Times reports. “Facing a White House blockade, the Food and Drug Administration is seeking other avenues to ensure that vaccines meet the guidelines. That includes sharing the standards—perhaps as soon as this week—with an outside advisory committee of experts that is supposed to meet publicly before any vaccine is authorized for emergency use. The hope is that the committee will enforce the guidelines, regardless of the White House’s reaction.”
The shelving of his government’s own regulatory guidelines shouldn’t really come as a surprise at this point, but it does undermine public trust in whatever vaccine ultimately comes out of the many billions of dollars in investment. “FDA Commissioner Stephen Hahn has been attempting to shore up public confidence in the FDA’s vaccine review for weeks, vowing that career scientists, not politicians, will decide if the shots are safe and effective for mass vaccination,” according to the Associated Press. “But President Donald Trump has repeatedly insisted that a vaccine could be authorized before Election Day, even though top government scientists working on the administration’s vaccine effort have stated that that timeline is very unlikely.”
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