Mostly, the protocols are just thick volumes of procedures—the instruction manuals for the trials. How big a dose of vaccine will participants in the experimental group get, and how many? How will they be monitored, and for what symptoms? For how long? What will count as an infection? How will the data be accounted for? Publishing the protocols in advance is all about accountability. These are the rules the companies plan to abide by, available for criticism but also to ensure that nobody does any shenanigans on the other end, cherry-picking data or changing what counts as success.
The details, though, also give some clues as to how the next few months will go. For one thing, both protocols take so much time to put into action that it’s next to impossible that a vaccine will be available before Election Day. Everyone has to get two doses, and the studies must allow enough time to monitor their outcomes.
(I emailed representatives of the other six signatories to the vaccine science pledge asking if they, too, planned to release their research protocols. Spokespeople at Johnson & Johnson, Merck, GlaxoSmithKline, BioNTech, Novavax, and Sanofi all declined to comment.)
Still, even public protocols might not be enough to get the scientific community on board. Hotez hopes the companies will release not only their protocols but also their full Phase III data. He also wonders what an EUA might mean for the other vaccine trials. Ordinarily, ethics would dictate that once a vaccine is available, trials of other candidates should stop. By definition, the risks of those trials now outweigh the potential future rewards. Except here, those other candidates might be better, safer, whatever. EUAs don’t have any guidelines for that, and neither the FDA nor the president have articulated any. They might be forthcoming, but Hotez says he thinks the president is more interested in reelection than vaccines. “He wants a vaccine released under EUA, sort of now, right? He’s never created a national road map or response to Covid-19, this is undermining his candidacy for reelection, and he feels he needs a victory in the area of Covid-19 to be successful,” Hotez says. “But I don’t see a way by which we’d know that vaccines were safe and effective if he tries to release a vaccine in October. So we’re in a bit of a standoff. The scientific community is holding a line.”
It has to; there’s a lot to be suspicious about. Moderna’s leadership has been criticized for questionable stock trades and hyping preliminary results. And in early September, AstraZeneca officials announced that they were pausing their vaccine trial due to an “adverse event”—some kind of medical issue that forced the researchers to stop and determine whether it was a consequence of taking the vaccine. And it wasn’t the first time. A participant got ill in the summer, but they turned out to have a neurological disorder unconnected to the vaccine. This time, an otherwise healthy 37-year-old woman developed a spinal inflammation that looked like a neurological disorder called transverse myelitis, which some scientists think could be an immune issue. That’s disconcerting when it comes to vaccines. But AstraZeneca didn’t release those details on purpose; Stat got them via leaks from a presentation the company made to investors, and CNN obtained an internal report. That’s not transparency. (The trial has since restarted in the UK, and a spokesperson told me they expect it to restart in the US soon.)
And all of these political and scientific pressures combine, like separate wildfires cresting the same hill. When they swirl together with general anti-science sentiment and vaccine hesitancy, you get a fire tornado of skepticism. That’s why the trustworthiness of the science will be so important, and so important to communicate—to three disparate groups of people beyond the science community. One is antivaxxers and the vaccine-hesitant. Another is the people who have little information, who may even be outside the health care system altogether. “But the third group is the one that’s the most interesting in this case. They’re worried about the rush. They’re worried about the fact that there’s political pressure. So they’re going to be a little skeptical until they see pretty good evidence that the vaccine being offered is good,” says Christine Grady, chief of the Division of Bioethics at the National Institutes of Health Clinical Center. “Yes, you can message it. It’s not easy to do, but you can. The way the trial was run, ethically and methodologically and rigorously, will matter a lot.” The key is making sure that the trials are run well, and then saying so loudly enough that people believe it.
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