Brace for some truly epic presidential sh*tposting about the FDA once this news starts circulating. The loathsome “deep state” tweet he sent last month when he was leaning on them to approve convalescent plasma as a treatment for COVID might end up looking tame by comparison.
The FDA has a serious image problem right now, partly of Trump’s making but partly of its own. They approved hydroxychloroquine for emergency use this past spring based on early observational studies and the president’s enthusiasm. Then they sheepishly rescinded that authorization when clinical trials failed to prove HCQ’s effectiveness. Something similar happened with plasma. The president was enthusiastic about that treatment too, especially with the GOP convention impending, and plasma had already been used extensively in a study by the Mayo Clinic. So they approved plasma for emergency use — even though no clinical trials had proved its effectiveness against COVID in this case either.
Then FDA chief Stephen Hahn went out alongside Trump at a press conference and badly botched the data on how helpful plasma is in saving lives, overstating its effectiveness wildly.
All of that played out against a backdrop of other news about the White House pressuring the CDC to conform its COVID guidance to better suit Trump’s political interests. This is a uniquely bad moment to shake the public’s trust in the integrity of the federal government’s science wing but the president’s done it repeatedly for his own selfish electoral interests and the FDA and CDC have done it repeatedly through their own incompetence. Literally within the last few hours, in fact, new evidence that the CDC can no longer perform its most basic professional duties emerged:
I know people think political interference drove this embarrassing @CDCgov website move. But sources tell me no. “No White House interference. We shot our own foot,” one scientist explained. https://t.co/7TZE0a5lsg
— LenaSun (@bylenasun) September 22, 2020
So here we are, with Trump boasting about the imminent arrival of a vaccine on the trail every day and the American public watching this spectacle play out warily, with the FDA poised to make what may be the most momentous decision in the history of the agency, whether to approve a new COVID vaccine for emergency use. They need to do something to rebuild the public’s trust that that approval will be granted on the merits, without any corner-cutting to suit Trump’s electoral agenda. And so, according to WaPo, they’re about to take a major confidence-building measure. They’re slowing the process down.
The Food and Drug Administration is expected to spell out a tough, new standard for an emergency authorization of a coronavirus vaccine as soon as this week that will make it exceedingly difficult for any vaccine to be cleared before Election Day…
With the vaccines, the FDA is expected to ask manufacturers seeking an emergency authorization — a far quicker process than a formal approval — to follow participants in late-stage clinical trials for a median of at least two months, starting after they receive a second vaccine shot, according to two individuals familiar with the situation who spoke on the condition of anonymity to discuss information before it is made public.
The agency also is looking for at least five severe cases of covid-19, the disease caused by the coronavirus, in the placebo group for each trial, as well as some cases of the disease in older people, as a sign the vaccine works…
The FDA, in the new vaccine guidance, is expected to say that it will require data for an emergency authorization that is close to that required for a full approval, according to recent comments by officials. That’s a higher bar than is typical for an emergency authorization, which requires only that a product “may be effective,” and the likely benefits outweigh the harms. The tougher standard is appropriate, officials have said, because a vaccine is given to healthy people, not to those who are ill.
“Two months of follow-up would make it unlikely the companies would have enough data before mid-November,” the Post notes. All of the most advanced vaccines require two shots, I believe, with the second given 30 days after the first. If the FDA is tacking on two months of tracking trial subjects *after* the second shot for assurance that there are no serious adverse effects from the vaccine, that means there probably won’t be data by November 3. Pfizer’s phase-three trial was far enough along that they were aiming to have some data by late October, but if the FDA follows through with this new rule it may push them past Election Day as well.
Not even joking: How soon before Trump accuses the agency of having concocted this rule because it’s trying to tank his election chances rather than trying to restore public confidence in the eventual vaccine?
I wonder if that’s why this news leaked to WaPo before the FDA formally announced its new standard. Maybe the agency suspects, quite reasonably, that if the public doesn’t get wind of their intention to implement this new rule now, the White House might try to quash it behind closed doors before it’s revealed. Now that this story’s out there, there’s no way for political actors to block the FDA from putting the new standard into effect without those actors looking incredibly shady to the public.
Which leads to another question. Does this story solve yesterday’s mystery of why HHS chief Alex Azar issued a new policy this week requiring him to sign off personally on any new rules proposed by agencies like the FDA? I couldn’t figure out why Azar would do that; Trump’s top priority right now is getting a vaccine approved ASAP but requiring Azar’s sign-off would add a new layer of bureaucracy, slowing the process down. Today’s news provides a possible motive, though. If Azar knew the FDA was working on a new rule for approving the vaccine that would itself slow the process down, he’s now in a position to block that rule and keep things moving quickly. Conceivably, Azar could quash the FDA’s confidence-building process in order to speed through an emergency-use authorization before the election, just as Trump wants.
Maybe that’s why this story leaked. After Azar’s new policy took effect, it’s possible that FDA scientists decided to outmaneuver him by sharing their plans for their new rule on approving the vaccine with the press. We’ll see how Azar reacts to it. It could be that I have it all wrong and that he’s on board with this idea as well. But it seems unlikely, knowing his boss will react to it.
One thing that’s not in dispute: Someone needs to do something, urgently, to reassure Americans that whatever ends up going into their arms will be safe and effective. I’ll leave you with this data from Axios. Not great.