The CEOs of all the leading Western developers of COVID-19 vaccines have vowed to only file for FDA approval after demonstrating safety and efficacy in phase 3. The pledge comes amid reports that the Trump Administration is pushing for a vaccine to be approved before the November election.
In the weeks between now and the election, it is possible that some companies will share data from fairly large assessments of their COVID-19 vaccines but not full results from the 30,000-subject phase 3 studies they are running to win approval in the U.S. If that happens, a company could file for—and potentially get—emergency use authorization on the strength of evidence that falls short of the level required by FDA guidance, leading to claims of political interference and harm to trust in vaccines.
Against that backdrop, the CEOs of AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer and Sanofi have signed a joint pledge. One of the commitments is to “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 nine companies are collectively working on all of the major vaccines tipped to come to market in the U.S. over the next nine months, suggesting that a COVID-19 prophylactic will only become widely available in the country once one of them has completed phase 3. The BioNTech-Pfizer collaboration has set the most aggressive target for completing phase 3 but that could still fail to yield a pre-election approval.
Concerns about regulatory independence and the implications for COVID-19 vaccines in an election season intensified following the emergency authorization of convalescent plasma and, particularly, a press conference involving President Donald Trump and FDA commissioner Stephen Hahn. The event raised concerns that political considerations are influencing decision making at the FDA.
A letter put out by BIO last week stated “FDA should maintain its historic independence” and “political considerations should be put aside,” but the nine CEOs shied away from explicitly linking their pledge to the events of recent weeks and concerns Trump will push for a premature approval.
Rather, the CEOs pledged to “always make the safety and well-being of vaccinated individuals our top priority” and to “continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes.” Those statements, and the broader pledge, could be interpreted as a response to the political situation, but the CEOs opted against more explicit and potentially incendiary comments.