WTF? The Food and Drug Administration’s (FDA) panel of experts questioned the safety and efficacy of its own rules around emergency COVID-19 vaccine approval at an advisory meeting Thursday. In the meantime, infuriated by the FDA’s defiance in a showdown over the Trump administration’s standards for authorizing a coronavirus vaccine, health secretary Alex Azar has spent recent weeks openly plotting the ouster FDA chief Stephen Hahn. At this point, who in their right mind is going to trust a COVID vaccine?
A senior administration official told Vanity Fair, “No one has pressured the FDA to rush through an approval. They have all just noted the urgency of the situation and encouraged FDA to work expeditiously.” White House spokesperson Sarah Matthews said the administration has done everything it can to streamline the vaccine-approval process “while ensuring it is fully backed by the science.”
Nothing is more scary to people than the prospect that the Trump administration, for purely political reasons, would turning a COVID-19 vaccine into an October surprise, offering a potentially unsafe shot to millions of healthy Americans. Such politicization, they have feared, could feed already-burgeoning vaccine hesitancy, and disrupt ongoing clinical trials of a vaccine that could serve as the only real exit ramp from a devastating pandemic.
In the last few months, as the president and his surrogates have pressed for speed, the FDA’s career scientists have battled back, using abstruse FDA guidances to pharmaceutical companies and acronym-laden advisory committees to build a bulwark against political interference. Their efforts to increase transparency and guarantee safety have tacked several months onto the accelerated timetable.
Then there is Trump’s denial. At last night’s debate, he said that we have turned a corner in COVID-19 while some states are again recording more cases than their ER’s can handle.
Thursday was the first day with more than 70,000 new US Covid-19 cases in three months, and the hospitalization rate is soaring, new data reveal. Thirty-two states reported rising Covid-19 infections, according to data from Johns Hopkins University.
Trump continues to downplay the severity of the virus and defend his early reaction — restricting travel from China — and promising, despite the facts, that a vaccine will be ready shortly.
Right now, the number of people who said they would get a COVID-19 vaccination is down to around 50%, according to Gallup. I think you have to really be afraid or have a screw loose to get an approved vaccination when available.
Let’s hope that President-elect Biden’s first and foremost list of to-dos is to reestablish our trust in science and the FDA.