Amid fears of political pressures to rush a vaccine for COVID-19, nine CEOs of biopharmaceutical companies working on these candidates have signed a pledge to uphold the scientific process and safety in any development.
The companies include AstraZeneca, BioNTech, GlaxoSmithKline plc, Johnson & Johnson, Merck, Moderna, Inc., Novavax, Inc., Pfizer Inc., and Sanofi, some of the most prominent names working toward vaccines currently. This wasn’t a simple assertion of intent, either — the pledge outlined several specific commitments to which all have committed. All commitments were reached following guidance from regulatory authorities and in conjunction with existing standards and practices, to aid public health.
These pledges included broad statements, such as making the safety and well-being of vaccinated individuals their top priority and adhering to high scientific and ethical standards on clinical trials and manufacturing, as well as more specific dedications, like only submitting for approval or emergency use authorization after showing safety and efficacy through phase 3 clinical studies and working to guarantee a sufficient supply and range of vaccine options available for global access.
“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 CEOs said in their letter. “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.”
Together, they stated that they believe this pledge will help ensure public confidence in the process utilized to produce and approve a COVID-19 vaccine, and finally begin to bring the pandemic to heel.