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As public confidence in the drug development process waivers, leading vaccine developers promise to adhere to scientific and regulatory principles.
The unprecedented speed of, as well as the perceived politicization of, the drug development process has undermined public confidence in the integrity of COVID-19 vaccines in development, prompting bio/pharmaceutical companies to issue a public statement committing to the delivery of safe and effective vaccines.
On Sept. 8, 2020, the chief executive officers of nine companies leading the vaccine development charge—AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer, and Sanofi—issued a joint public statement, committing to adhere to the scientific process and regulatory guidelines, prioritize patient safety, and ensure a sufficient supply and range of vaccine options. The companies also pledged in the statement to “continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes.”
While facing pressure to expedite the submission of vaccines for approval, the companies committed to “Only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase III clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA,” according to the statement.
In a Sept. 3, 2020 letter, leaders of the Biotechnology Innovation Organization (BIO) urged biopharmaceutical companies to apply scientific principles in seeking drug and vaccine approvals. Separately, drug company executives stated in a Sept. 3 press conference that the companies would not seek early authorization or approval of a new COVID treatment without results from randomized clinical trials that demonstrate product safety and efficacy.