Pharma leaders sign historic pledge to ensure public safety when developing vaccines
Nine major pharmaceutical companies have made a pledge to uphold the safety and ethical standards required for developing and testing potential Covid-19 vaccines.
The pledge comes shortly after president Donal Trump insinuated that a vaccine for the virus could be released before the end of the year, and before the November election.
The pledge, made by the CEOs of AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer, and Sanofi, makes clear their commitment to developing and testing Covid-19 vaccine candidates in accordance with high ethical standards and sound scientific principles.
The pledge references how vaccines are assessed by expert regulatory agencies around the world such as the FDA, and how those agencies have clear criteria for the authorisation and approval process. It mentions how regulatory approval must be based on “large, high-quality clinical trials that are randomised and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations.”
In particular, the companies pledge to:
- Always make the safety and well-being of vaccinated individuals our top priority.
- Continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigour of manufacturing processes.
- 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.
- 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," it reads.