CEOs of nine bio-pharma companies pledge to put safety first on Covid-19 vaccines

Our Bureau. Mumbai | Updated on September 08, 2020

The first results showing whether a vaccine can stop people from getting the virus could come by mid-September from AstraZeneca Plc

The chiefs of nine multinational biopharmaceutical companies in the race to develop vaccines against Covid-19 have taken a pledge “to uphold the integrity of the scientific process” as they work towards getting global regulatory filings and approvals for what will be the first vaccines against the virus.

Companies involved

The companies taking the historic pledge include AstraZeneca, BioNTech, GlaxoSmithKline plc, Johnson & Johnson, Merck (known as MSD outside the United States and Canada), Moderna Inc, Novavax, Inc, Pfizer Inc, and Sanofi.

In a signed pledge, they saidthey wanted to make clear their on-going commitment “to developing and testing potential vaccines for Covid-19, in accordance with high ethical standards and sound scientific principles”.

“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,” they said.

The pledge comes even as reports coming in from different parts of the world suggest that people are nervous of taking fast-tracked vaccines. Presently, AstraZeneca, Pfizer-BioNTech and Modern are at the forefront with their vaccine candidates.

“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)”, the pledge said. FDA has established clear guidance for the development of Covid 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.

The chiefs further pledged 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; and work to ensure a sufficient supply and range of vaccine options, including those suitable for global access”.

Vaccines developed

Together, 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, a note on the pledge said.

Published on September 08, 2020

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