Another day, another horrifying COVID-19 milestone: This week the number of US cases topped 6 million. The death toll now exceeds 180,000.
An equally undeniable truth is that life as we know it, as we once lived it — complete with in-person sporting events and theater and concerts — will not return until there is a safe and effective vaccine, widely trusted and administered.
And there’s certainly no shortage of effort. At least a dozen US firms are working on a COVID-19 vaccine. Two are in Phase 3 clinical trials already (one made by Moderna and the other by Pfizer/BioNTech). The so-called Oxford vaccine by AstraZeneca begins trials in the US this week, and Johnson & Johnson’s entry into the Phase 3 field is expected later this month. It is widely anticipated that a vaccine could be available by the end of this year or early 2021.
But President Trump has made it clear, in speeches and on Twitter, that his target date is some time ahead of the Nov. 3 election — an “October surprise” that would somehow make the voting public forget how his ineptitude has contributed to the spread of this dreaded virus. And now the Trump appointee at the head of the Centers for Disease Control and Prevention has alerted governors to get ready to distribute a COVID-19 vaccine by Nov. 1.
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So the real question now is: Can the Food and Drug Administration, which approves vaccines for safety and effectiveness, be bent to the will of the bully in the White House? Can this once respected agency be cowed into putting politics ahead of science in greenlighting a vaccine that has not yet proved its worth?
Federal Drug Administration Commissioner Stephen Hahn has said, as recently as Tuesday morning, in an interview on CBS News, “I can tell you our decision at FDA will not be made on any other criteria than the science and data associated with these clinical trials.”
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While he insisted his agency “will not make that decision on the basis of politics,” he left the door wide open for a possible Emergency Use Authorization before those Phase 3 clinical trials are completed.
That — and the agency’s very recent history in responding to Trump’s demands — are causing serious and well-deserved anxiety in the scientific community.
After all, this was the same agency that approved emergency authorizations for two coronavirus treatments — hydroxychloroquine (an authorization since rescinded) and, most recently, for the use of convalescent plasma while touting false claims of its benefits. The latter approval allowed Trump to stage a news conference just before the Republican National Convention to make the grand announcement.
But emergency authorizations for treatments, especially for patients so ill that there are no other options, are a far cry from injecting healthy people with a vaccine whose safety and efficacy have not been thoroughly vetted during Phase 3 studies — the gold standard of scientific risk assessment for medical interventions. Here the ancient medical credo “first, do no harm” must apply.
Shortcuts driven by political concerns and the electoral timetable aren’t merely cynical, they could also have long-term consequences that would in fact make them counterproductive.
There is already public pushback against vaccines generally. Even the entirely sensible idea of mandating flu vaccinations for school-age children riled some Massachusetts residents enough to spur a recent State House demonstration.
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A Gallup Poll conducted in early August found that while 65 percent of those surveyed would readily sign up for a COVID-19 vaccination today, 35 percent would not — a shockingly high number considering the current death toll. That number rises to 41 percent for nonwhite Americans, who in fact have suffered disproportionately from the disease.
And those poll numbers were predicated on full FDA approval, not a truncated Emergency Use Authorization timed to generate Election Day headlines.
Operation Warp Speed, as the Trump administration has dubbed its efforts to hasten delivery of a vaccine, has been financed with more than $10 billion in federal funds — most of that in the form of prepayment for hundreds of millions of doses of vaccines once one or more have been approved by the FDA. That investment and jump-starting the manufacturing process are entirely appropriate roles for the federal government to play.
Meanwhile governors, through the National Governors Association, and the National Academies of Sciences, Engineering, and Medicine, at the direction of the National Institutes for Health and the CDC, are wrestling with the thorny issue of how those initially scarce doses of vaccine will be distributed — while there is still time for rational discussion.
But protocols prepared by those groups look to prioritize front-line health care workers and the most vulnerable — in other words, those already at high risk. Factoring that into the quest for a vaccine leaves little margin for error in the clinical trials process.
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This is no time for shortcuts — and certainly no time for putting politics ahead of science.
Editorials represent the views of the Boston Globe Editorial Board. Follow us @GlobeOpinion.
