As President Donald Trump repeatedly touts the possibility of a Covid-19 vaccine winning approval by Election Day, the companies he needs to make that happen are pushing back. And that’s a good thing all around.
On Tuesday, nine major coronavirus vaccine developers — including Pfizer Inc., AstraZeneca Plc, and Moderna Inc. — signed a joint pledge under which they committed not to submit their inoculations for Food and Drug Administration approval until they demonstrate safety and efficacy in a large, late-stage trial. It’s an unusual statement; typically, the FDA is the one defending high standards, while drug manufacturers try to push boundaries. Unprecedented political pressure, combined with public unease over what some fear may be a rushed process, has forced a role reversal.
The statement is a laudable first move by an oft-criticized industry. The FDA and drugmakers have laid the groundwork for proper evaluation, with the agency requesting and pharma running 30,000 person trials to prove that the vaccine can prevent or cut the severity of disease by at least 50%. If everyone is patient, these studies will give reliable answers, which is what you want for shots that will eventually be used by millions. But the president’s calls for speed and seemingly limited resistance from FDA commissioner Stephen Hahn have created concern that the agency might prematurely approve a vaccine and sow dangerous doubts. Someone had to step up to grow trust in the process, and the pharmaceutical industry may have felt it had no other choice. After all, the stakes are high: A successful vaccine represents the most promising way out of the pandemic. It’s not a situation where errors are acceptable.
Hahn says that a vaccine could be available before Nov. 3, an unusual statement from a regulator, and that he would consider authorizing one before advanced phase 3 trials are complete. But companies are responding to more than just soundbites. His agency appeared to bow to the administration with its approval of hydroxychloroquine to treat Covid-19, a move that was soon retracted amid health concerns. More recently, and just shortly after the president effectively accused FDA staff of working to harm his election chances, the agency approved plasma from recovered patients as a coronavirus treatment based on limited data and exaggerated its benefits.
The drug industry’s vaccine pledge should give some comfort that approval will rely on solid data. And yet, it could go even further to ensure public confidence in the process.
The signatory companies said they will “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.” The statement doesn’t detail exactly what “demonstrating safety and efficacy means.” The FDA has documented its expectations for full approval and will reportedly hold to the same guidelines for emergency authorization, which offers a faster pathway with lower and more flexible standards. But it’s hard to trust that the agency will stand up to pressure from the White House, and that should prompt the industry to fill in the blanks.
Ideally, companies would explicitly commit to delaying any application or distribution until phase 3 trials are fully enrolled with patients and firmly prove that it protects at least 50% of those inoculated. It’s not so overwhelmingly high a bar that companies should be trying to duck under it. And while a preliminary answer on protection from the virus could come fast if a vaccine is highly effective, companies should commit to waiting to file with the agency until there’s at least a month of reported side-effect data for most vaccinated participants to bolster safety confidence. Finally, the data submitted to the FDA should be made publicly available to the greatest extent and as quickly as possible. Further review by external scientists can only bolster confidence and the case for approval.
The FDA and industry must get this right. Approving a vaccine too quickly risks new side effects emerging or a longer pandemic if protection proves wanting or waning. People also need to believe in the shot. If they feel the approval is rushed or politicized, then they are less likely to get a vaccine when it’s available. A bad result could permanently damage trust in medicine in the U.S.
The industry is already showing bravery by standing up to the president, and though difficult, a few further steps could do even more to bolster its reputation and shore up public confidence.