Ensure Covid-19 vaccine trials follow `scientific process’: MNCs
10 Sep 2020
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Nine of the top multinational biopharmaceutical companies engaged in the development of Covid-19 vaccine have come together to ensure that vaccines submitted for approval or emergency use authorisation have demonstrated safety and efficacy through Phase 3 clinical trials that meet the regulatory requirements of regulators such as the US FDA.
The CEOs of AstraZeneca, BioNTech, GlaxoSmithKline plc, Johnson & Johnson, Merck (known as MSD outside the United States and Canada), Moderna Inc, Novavax Inc, Pfizer Inc, and Sanofi, today announced a pledge, outlining a united commitment to uphold the integrity of the “scientific process” towards potential global regulatory filings and approvals of the Covid-19 vaccines.
Nine CEOs sign historic pledge to continue to make the safety and well-being of vaccinated individuals the top priority in development of the first COVID-19 vaccines Work to ensure a sufficient supply and range of vaccine options, including those suitable for global access.
“We, the undersigned biopharmaceutical companies, want to make clear our on-going commitment to developing and testing potential vaccines for Covid-19 in accordance with high ethical standards and sound scientific 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).
“FDA has established clear guidance for the development of Covid-19 vaccines and clear criteria for their potential authorisation 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 randomised and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations.
“Following guidance from expert regulatory authorities such as FDA regarding the development of Covid-19 vaccines, consistent with existing standards and practices, and in the interest of public health, we 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 rigor of manufacturing processes.
“Only submit for approval or emergency use authorisation 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,” the pledge signed by the nine CEOs read.
They also pledged to work towards ensuring a sufficient supply and range of vaccine options, including those suitable for global access, in a move to gain public confidence in what they called “the rigorous scientific and regulatory process by which Covid-19 vaccines are evaluated and may ultimately be approved.”
They also claimed “these nine companies have collectively developed more than 70 novel vaccines that have helped to eradicate some of the world’s most complex and deadly public health threats, underscoring their experience in clinical development and regulatory rigor, as well as their longstanding commitments to patient safety and public health.”
