The CEOs of AstraZeneca (NYSE:AZN), BioNTech (NSDQ:BNTX), GlaxoSmithKline (NYSE:GSK), Johnson & Johnson (NYSE:JNJ), Merck (NYSE:MRK), Moderna (NSDQ:MRNA), Novavax (NSDQ:NVAX), Pfizer (NYSE:PFE) and Sanofi (NYSE:SNY), all of whom are developing vaccine candidates, all signed the pledge, which vows to “uphold the integrity of the scientific process” as they pursue regulatory approvals of the first vaccines for the novel coronavirus.
“FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US,” the pledge states. “FDA’s guidance and criteria are based on the scientific and medical principles necessary to clearly demonstrate the safety and efficacy of potential COVID-19 vaccines.
“More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high-quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations.”
The companies all pledged to make the safety of vaccinated individuals a top priority and to adhere to scientific and ethical standards with clinical trials and manufacturing processes.
Additionally, they said they will only submit for approval or emergency use authorization (EUA) after demonstrating safety and efficacy through a Phase 3 clinical study designed to meet the requirements of the regulatory bodies. They also vowed to ensure a sufficient supply and range of vaccine options.
“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 statement concluded.
The pledge does not reference any outside pressures but likely comes in response to claims from President Trump that a vaccine is coming soon. In a Labor Day address, Trump said “the faster, the better,” when it comes to getting a vaccine out there, suggesting that, while the hope remains that a vaccine will be approved by the end of the year, it may come as soon as October.
Democratic vice presidential nominee Kamala Harris was asked if she’d trust a Trump-endorsed vaccine, telling CNN that she “would not trust his word,” but “would trust the word of public health experts and scientists.”