The White House has made the decision to block a new slate of guidelines for Covid-19 vaccines, halting the latest attempt by the Food and Drug Administration to introduce some measure of regulatory rigor to a race that has escalated into a desperate rush to the finish line.
In addition doubling down on safety and quality control, the guidance was drafted with the intention of assuring an increasingly wary public that all vaccine candidates will be held to the same standards. But it appears that the priorities of the current administration lay elsewhere.
According to Politico, it was primarily “private-sector opposition,” rather than anything of concern to the average American, that led the White House to take issue with the FDA guidance. This alone should give us pause. Of course pharmaceutical companies will oppose that which interferes with their ability to make money and push product. To curb their avarice is why regulatory agencies exist in the first place.
Another underlying motivation isn’t explicitly acknowledged, but easy enough to read between the lines. One of the proposed FDA guidelines, the New York Times reports, is a follow-up to late-stage trials at least a few months long that would allow researchers to continue monitoring volunteers for adverse and protective effects. Extending the timeline for vaccine approval to accommodate this would push the earliest possible end date well past November 3—denying President Trump and his campaign the opportunity to exploit any so-called success for reelection purposes.
Days before the White House announced their decision, CNBC published a follow-up report of their own that details the side effects experienced by some of the participants in Pfizer and Moderna’s phase III trials. One volunteer described a 12-hour blitz of “full-on Covid-like symptoms.” Others agreed that the vaccine’s aftereffects, which included high fever, pounding headaches, intense chills, and exhaustion, blew over relatively quickly, but were more debilitating than expected.
These reports of adverse symptoms are far from the first. In May, a 29-year-old man who volunteered for Moderna’s phase I trials shared details about the “severe reaction” he had to the highest dosage of their vaccine with STAT News. The results of that 45-person study, published months later in July, revealed that he was one of four to experience “grade 3” symptoms, classified as critical but not life-threatening. A life-threatening reaction in one person is grounds enough for suspension, as was suspected to be the case for the AstraZeneca vaccine studies put on hold last month.
We must remember that to date, the adults who have participated in Covid-19 vaccine trials are healthy. If they exhibit adverse symptoms, it only makes sense that those of us more vulnerable to this disease, whether due to age or underlying conditions, will have it worse. About 15 percent of the older adults who volunteered for a Moderna phase I trial developed symptoms so severe as to require hospitalization. Granted, they received a higher dose than we would in a physician’s office, but what occurs at high doses for a few people is bound to occur at low doses for many people. The “many” in this case is millions—including children, another population we can’t discount.
Distributing a vaccine nationwide without evaluating and validating its safety beyond a shadow of a doubt isn’t a risk that any leadership invested in the wellbeing of its people should be willing to take. Ultimately, it will fall to an advisory committee to determine whether a Covid-19 vaccine might receive emergency use authorization (EUA) before Election Day. But if the EUA issued in August for convalescent plasma, a suspect and scientifically unsubstantiated treatment, is anything to go by, we cannot expect their decision to be impervious to political pressure.
Just how much is the White House willing to sacrifice so its leaders might claim electoral victory? After losing so many to this virus already, we can’t afford to find out. Those still capable of honoring due process must do so.
The author has reached out to Pfizer and Moderna for comment. Neither has responded.