- The CEOs of nine pharmaceutical companies signed a letter vowing only to seek emergency approval of their experimental coronavirus vaccines after they prove safe and effective in a large-scale clinical trial.
- The nine top executives run coronavirus vaccine developers AstraZeneca, Moderna, BioNTech, Pfizer, GlaxoSmithKline, J&J, Merck, Novavax and Sanofi. Several of them have begun late-stage testing and could be in position to seek an emergency use authorization from the FDA — an unusual clearance granted during a public health crisis — before the end of the year.
- The letter comes after multiple reports the Trump administration has considered granting emergency authorization of a vaccine before the presidential election and prior to obtaining full results from Phase 3 testing. The Centers of Disease Control and Prevention recently told states for prepare for vaccine distribution by Nov. 1.
The drug industry is at a crossroads. Pharma and biotech companies could save thousands of lives and curb the pandemic if they produce, in record time, safe vaccines proven to prevent COVID-19. But seeking clearance of a vaccine before then, during the height of presidential election campaigns, could backfire with an already hesitant public.
Tensions have built for months as coronavirus case numbers remain at high levels in the U.S. and around the world. A recent decision by the Food and Drug Administration to clear emergency use of convalescent plasma without data from a rigorous trial further heightened concerns of a hasty approval process.
The agency's decision — and Commissioner Stephen Hahn's misleading description of it — led many scientific experts to publicly question the independence of the FDA. Just a day earlier, President Trump had attacked the FDA on Twitter for delaying COVID-19 treatments.
Vaccines, though, are a greater test, given their potential use in tens of millions of healthy individuals. Candidates from AstraZeneca, Moderna, as well as partners BioNTech and Pfizer, are now in Phase 3 trials in the U.S. Pfizer CEO Albert Bourla has said that the company could seek an emergency approval as early as October.
As these trials have progressed, multiple reports emerged suggesting the Trump administration could fast-track a vaccine before the November election. FDA's Hahn told the Financial Times he'd be willing to clear a vaccine early, as long as the benefits outweighed the risks. During a Friday speech, Trump said a vaccine could be ready in October, contradicting the predictions of top health officials.
Politicization of the approval process could compound a growing mistrust some Americans have of vaccines, despite decades of evidence proving them to be safe and effective for widespread use against a variety of infectious diseases.
With reputations at stake, vaccine developers have taken stronger public positions against any potential political interference in approval of their products.
AstraZeneca, last week, pledged it was "moving quickly without cutting corners." The trade group BIO, on Sept. 3, called on the FDA to "maintain its historic independence" and for its members to ensure the use of any new products should be "data-driven."
Tuesday morning, the CEOs of nine companies that, combined, have made more than 70 approved vaccines, signed a letter pledging to only file for an emergency approval of a coronavirus shot after safety and efficacy has been shown in a Phase 3 study designed to meet regulatory standards.
They added that they'll maintain the "high scientific and ethical standards" of clinical trials and vaccine manufacturing, and will work to "ensure a sufficient supply and range of vaccine options, including those suitable for global access."
"We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be approved," the CEOs wrote.
Pfizer said last week that it had enrolled some 25,000 of the 30,000 planned participants in its Phase 3 trial. Moderna, at around 21,000 as of Friday, is slightly behind with its trial, but has reportedly slowed enrollment to recruit a more diverse study population, a key consideration of developers as they prepare for a mass vaccination campaign. AstraZeneca just began its Phase 3 study, while J&J and Novavax could follow this month.
The FDA will convene an advisory panel on Oct. 22, though it's not expected to consider any approval applications.