Amid growing concerns that the Trump administration may try to rush a vaccine against the virus that causes Covid-19 to market prematurely, nine biotech and pharmaceutical CEOs have signed a pledge designed to assure the public that they will stick to scientific and ethical principles.
“The safety and efficacy of vaccines, including any potential vaccine for Covid-19, is reviewed and determined by expert regulatory agencies around the world, such as the United States Food and Drug Administration (FDA),” read the statement, which was released Tuesday. “FDA has established clear guidance for the development of Covid-19 vaccines and clear criteria for their potential authorization or approval in the US. 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.”
The letter was signed by AstraZeneca CEO Pascal Soriot; BioNTech CEO Ugur Sahin; GlaxoSmithKline Emma Walmsley; Johnson & Johnson CEO Alex Gorsky; Merck CEO Kenneth Frazier; Moderna CEO Stephane Bancel; Novavax CEO Stanley Erck; Pfizer CEO Albert Bourla; and Sanofi CEO Paul Hudson.
The signatories pledged to prioritize vaccinated individuals’ safety and well-being; adhere to high scientific and ethical standards regarding clinical trial conduct and manufacturing; only seek approval or authorization after demonstrating safety and efficacy in Phase III trials; and work to ensure a sufficient range and supply of vaccine options.
“We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory processes by which Covid-19 vaccines are evaluated and ultimately may be approved,” the statement read.
That confidence has been badly shaken in recent weeks amid growing concerns that the FDA may yield to political pressure from the Trump administration and rush a vaccine against the SARS-CoV-2 virus to market, and that President Trump is hoping one becomes available in October in order to help his reelection prospects. Such concerns have not been assuaged by recent actions and comments on the part of FDA Commissioner Stephen Hahn, who was seen as caving in to pressure when the FDA granted authorization to convalescent plasma as a treatment for Covid-19. Days later, the Financial Times quoted Hahn as suggesting he would be open to green-lighting a vaccine before Phase III results became available.
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