If you are at death’s door, it might not seem so risky to go skydiving with an instructor who hasn’t completed her training. Likewise, for a person dying in the hospital of an illness without a cure, there can be good reason for the government to expedite access to experimental therapies whose safety and effectiveness has not been fully established by researchers. Such patients are often willing to take greater risks, even if it could trigger a bad reaction. That was the rationale, for instance, behind accelerating the approval of treatments for HIV in the 1990s. It’s also the rationale behind emergency use authorizations, or EUAs, established by the 2004 Project BioShield Act to allow the US government to make medical products available before they’ve been fully vetted in health emergencies like bioterror attacks.
But what about taking a healthy child skydiving — wouldn’t you want more assurances about the instructor and the parachute? That’s what it would be like to give a poorly understood vaccine to people who are perfectly healthy, with the purported goal of protecting them from an illness that might or might not infect them, that might or might not make them sick even if it does infect them — and that carries a low risk of death. That’s what you might call reckless on two fronts: It could endanger healthy people with very serious side effects. And it could compromise public trust in the experimental vaccine or another vaccine in the long run, even when it is proven to be effective and safe.
There’s an even greater danger of approving a vaccine too early — beyond that to individuals who might take it. It’s that companies could stop clinical trials prematurely, before they yield critical information about whether the vaccines reduce moderate and severe forms of the disease, or just mild cases, and whether the vaccines simply prevent illness or also prevent people from spreading COVID-19. Ongoing study is critical to get data on how vaccines work for children, teens, people of color, and pregnant women who are not part of the initial trials. And approving a vaccine that is mediocre too early could thwart the ability to develop a better vaccine; volunteers might opt to take the approved immunization instead of being part of the studies. In other words, rushing a vaccine could mean it takes far longer to stop the pandemic.
Right now, the Trump White House appears to be gunning to approve an experimental COVID-19 vaccine by Election Day with the loose standard used to approve drugs for patients who are in dire moments, facing down death. On Tuesday, The Washington Post reported the hopeful news that the Food and Drug Administration plans to tighten its standards for issuing an EUA for a COVID-19 vaccine. But within 24 hours, the president declared at a press briefing that any such move would be subject to his approval. That promise of political interference follows a memo last week from Trump appointee Alex Azar, secretary of health and human services, asserting he would seize the power of rule-making held by the FDA — within his authority, since the agency sits in his department, but foreshadowing an unprecedented politicization of the scientific review of medical products.
It should not surprise anyone if this White House asks that a vaccine maker prove only that “it is reasonable to believe that the product may be effective,” per the 2004 law. Forget the gold standard of three phases of clinical trials, which for a typical FDA approval must provide “substantial evidence” that vaccines are effective and safe. With the president keen to declare victory on the pandemic to secure reelection, the American public is at risk of being served up an FDA-approved vaccine this fall that has not been adequately vetted by medical researchers, with none of the typical assurances that vaccines approved for the US market have of being effective and safe.
The American public’s skepticism about a COVID-19 vaccine is growing amid the Trump administration’s persistent political maneuverings and attempts to manipulate scientific experts at the Centers for Disease Control, the FDA, and the Biomedical Advanced Research and Development Authority. A recent poll from the Pew Research Center suggests that only about half of Americans would definitely or probably take a COVID-19 vaccine if one were available today, down from the 72 percent of Americans who said they would likely take one in May. Forty-nine percent said they would probably or definitely not take a vaccine available today.
Let’s be clear: Just because a given vaccine is expedited does not mean that Americans should inherently mistrust it — or for that matter, vaccines in general, which save millions of lives. But it does mean that if the Trump administration rushes approval of a vaccine before it has completed its Phase 3 clinical trials, which track the outcomes of thousands of patients, scrutiny will be warranted.
Earlier this month, nine companies pledged not to rush a vaccine and to follow FDA requirements for evidence, but they stopped short of saying they’d wait until they had full data from Phase 3 trials, stating that they would “only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA.” That leaves the door open for potential approval based on preliminary data if the FDA accepts it, with the trial less than complete. Three companies — Moderna, Pfizer, and AstraZeneca — have laudably made their protocols, which explain the design and methods of their clinical trials, public. If all vaccine makers followed suit it would be a good start, but they ought to do far more if they want the public’s trust. All the companies testing COVID-19 vaccines should release full protocols. All should pledge to share the full data from their Phase 3 clinical trials with the public. And all vaccine makers ought to simultaneously release to the public the full packages that they submit to the FDA. They should also clearly state that they will refuse to make their COVID-19 vaccines available before Phase 3 clinical trials are fully complete. Finally, they should pledge to continue their trials even after obtaining early authorization and to study how well the vaccine performs in the first round of authorized recipients, which figures to include health-care workers and emergency responders.
Taking a bold stand will help build trust with the public and also ensure that companies meet their obligations to their shareholders, given that a vaccine that ends up having dangerous side effects will not get traction or be profitable in the long run — even if government liability protection will shield the companies from patient lawsuits.
The White House’s gambit to get a vaccine into production by Election Day may well backfire when it comes to fighting the pandemic and may cost unnecessary American lives. No one should let the president declare victory. In these extraordinary times, we need leaders outside government to step up and fill in for an untrustworthy administration. Vaccine makers have the obligation and the business imperative to be fully transparent about their clinical trial data with the public. The American public deserves to know the true risks and benefits of any vaccine released to the market.
Editorials represent the views of the Boston Globe Editorial Board. Follow us on Twitter at @GlobeOpinion.