File photo of US President Donald Trump, left, and Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, during a news conference at the White House in Washington, DC on 22 April | Photo: Michael Reynolds | EPA via Bloomberg
File photo of US President Donald Trump and Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, during a news conference at the White House on 22 April | Michael Reynolds | EPA via Bloomberg
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North Carolina Democratic Senate candidate Cal Cunningham said during a debate Tuesday night that he would be “hesitant” to take a coronavirus vaccine if it’s rolled out in the next few months.

“I’m going to ask a lot of questions,” he said. “I think that’s incumbent on all of us right now with the way we’ve seen politics intervening in Washington.” Cunningham cleaned up his remarks after the debate, saying, “If public health professionals sign off, then I will not hesitate.” He said he’d encourage others to do the same.

The flap echoed one last month when the Democratic vice-presidential nominee, Senator Kamala Harris, made similar comments. She explained that she wouldn’t trust assurances from President Donald Trump that the vaccine was safe and feared that he’d sideline public health experts in the cause of his re-election. In that case, the person at the top of the Democratic ticket, former Vice President Joe Biden, took care of the cleanup himself. CBS News had this account:

“I’m worried if we did have a really good vaccine people would be reluctant to take it. So, he is undermining public confidence,” Biden said of the president. “But pray God we have it. If I could get a vaccine tomorrow, I’d do it. If it cost me the election I would do it. We need a vaccine and we need it now. We have to listen to the scientists.”

We’re only seven weeks from Election Day. There’s not going to be any large-scale distribution of a vaccine, even if one is approved before Nov. 3. There just isn’t time, no matter how much the approval process might be accelerated. At best, perhaps a vaccine could be offered to people like health-care workers who are designated most in need, but even that timetable is increasingly unlikely.

No, before the election the realistic possibility is that Trump might announce a vaccine breakthrough. That — what Trump says — is the thing that everyone should be (extremely!) skeptical about. But an actual vaccine, when and if it’s ready? That’s more complicated, and there’s a lot more than Trump’s word involved.

I’m no expert on vaccines, but I do know a little about government regulation. So I can say that there are basically three rings of protection for any regulated product such as a vaccine.

The top one is the presidency. Presidents have a strong incentive to get it right: If Trump vouches for the safety and efficacy of something and it turns out to be harmful or ineffective, he’ll be blamed. Because of that, normal presidents try to make sure that testing meets scientific standards. They like to make scientists visible and available to shoulder some of the blame if something goes wrong, knowing that if things go well then relieved voters will reward the president even if they don’t think he was involved. Unfortunately, Trump has shown that he doesn’t care about building a reputation for trustworthiness when it comes to science or anything else. Even worse, he’s pressured health authorities to approve discredited science that he presumably picks up from some friend, or from Fox News.

The second ring comprises the executive branch agencies. Until the Trump administration, their reputation was solid — often the best in the world. Some of the career scientists and experts — such as Dr. Anthony Fauci — are as good as ever. The leadership? Not so much. The recent plasma fiasco, in which the Food and Drug Administration was pressured to approve a new treatment and the FDA commissioner, Dr. Stephen Hahn, botched basic statistics in overselling its efficacy, was a red flag. The good news was that Fauci and other experts pushed back hard and fast, forcing Hahn to retreat. Gold-standard procedures appear to remain in place, and so are many experts who care about their agency’s reputation (and, for that matter, about public health).

The third ring consists of pharmaceutical companies. They have a strong incentive to protect their reputations. Even if they were indifferent about public health, as they surely are not, the last thing they want is to manufacture a faulty vaccine. They’re doing what they can publicly to emphasize their commitment to safety. It’s no doubt genuine. But the reputation incentive is accompanied by the incentive to develop a working vaccine first, with all the advantages that brings; that’s why regulation is needed.

Overall, the U.S. regulatory system has worked well in the past, and experts do not seem particularly scared that dangerous shortcuts will be allowed now, whatever the president might want. We’ve seen experts inside and outside the government speak out if they see something wrong, including when the president endorses quack remedies. Over time, Trump’s attitudes and actions are likely to reduce professionalism and enable hucksters and partisans to run the show. Everyone should be on alert for the possibility that White House pressure will undermine previously solid procedures. But so far, the main concern should be what Trump says, not what the agencies do.

As for the Democrats: The trick is to correctly call out Trump for attempting to undermine the regulatory process without feeding conspiracy theories and anti-vaccine worries. Leaders like Harris and Cunningham need to act responsibly, even if the president doesn’t, and that means foregoing some lines of attack because they tend to exploit vulnerable tendencies in some voters, with potentially disastrous effects. That doesn’t mean Trump can’t be attacked for his falsehoods about science. From bleach to hydroxychloroquine, he’s provided plenty of ammunition.


Also read: Why vaccines are a better bet against coronavirus than drugs


 

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