Stephen Hahn, the FDA commissioner, granted an emergency-use authorization for investigational convalescent plasma in hospital patients, which will expand access to the therapy. Earlier this month, two other leading health experts in the administration, Anthony S. Fauci, of the National Institute of Allergy and Infectious Diseases, and Francis Collins, director of the National Institutes of Health, reportedly expressed reservations about such a step, on grounds that the research is still too preliminary. Dr. Hahn’s agency went ahead, and Mr. Trump brushed aside reservations, saying “there might have been a holdup, but we broke the logjam over the last week, to be honest.” This came a day after Mr. Trump baselessly accused the FDA of impeding enrollment in clinical trials for coronavirus vaccines and therapeutics for political reasons, blaming some shadowy “deep state” for trying to delay until after the November elections.
We hope convalescent plasma lives up to the early promise. But if Mr. Trump’s intrusion in this case foreshadows attempts to short-circuit the rigorous testing of vaccines in order to distribute one before the election, the damage could be immense. Dr. Hahn has offered repeated assurances that the FDA will act solely on the basis of science. But given Mr. Trump’s demands, will Dr. Hahn resist? Once before, the White House put pressure on the FDA to give emergency-use authorization for the antimalarial drug hydroxychloroquine, which has shown no benefit in fighting the virus. What if Mr. Trump insists on a fast track for a vaccine that shows promise in preliminary trials but has not yet cleared the full scientific and regulatory regime? Will Dr. Hahn stand up to the president?
The temptation to take shortcuts is dangerous. This will be the largest mass immunization program in history. To successfully confront the pandemic, a vaccine must pass through a complex development and testing process, then be manufactured and distributed to exacting standards. Any slip-up can be catastrophic, not only in medical terms but in people’s confidence. Vaccine hesitancy, spread by misguided campaigners on social media, is already a serious problem. A mistake could endanger the whole enterprise — an effort Mr. Trump proudly and repeatedly boasts about — and leave people suffering far longer than necessary.