Nine Pharma CEOs Sign Pledge of Scientific Integrity for COVID-19 VaccinesBy
The chief executive officers (CEOs) of nine biopharmaceutical companies developing COVID-19 vaccines issued a safety pledge to show united commitment to uphold the integrity of the scientific process as they work toward potential global regulatory filings and approvals of the first COVID-19 vaccines.
These nine companies are: AstraZeneca, Johnson & Johnson, Merck & Co., GlaxoSmithKline, Sanofi, Pfizer, Moderna, a clinical-stage biopharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, BioNTech, a Mainz, Germany-based immunotherapy company, who is partnered with Pfizer in developing a mRNA COVID-19 vaccine.
“We, the undersigned biopharmaceutical companies, want to make clear our ongoing commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles,” said the nine CEOs in the pledge announced on September 8, 2020. “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). 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. 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’ safety pledge outlines four main elements: (1) always make the safety and well-being of vaccinated individuals the top priority; (2) continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes; (3) 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 the FDA; and (4) work to ensure a sufficient supply and range of vaccine options, including those suitable for global access.
The companies issued the safety pledge following concerns from public discourse of possible further accelerated timelines for COVID-19 vaccine development and availability.
In a separate development, AstraZeneca announced this week (September 9, 2020) that it has temporarily paused its clinical trials for its COVID-19 vaccine, AZD1222, to allow an independent committee to review the safety data of a single event of an unexplained illness that occurred in a Phase III trial in the UK. The company said the incident was found during standard review of the trial. See related story.