The top executives of nine drugmakers likely to produce the first vaccines against the new coronavirus signed an unprecedented pledge meant to boost public confidence in any approved vaccines.
The companies said Tuesday that they will stick to the highest ethical and scientific standards in testing and manufacturing and will make the well-being of those getting vaccinated their top priority.
The pledge was signed by the chief executive officers of American drugmakers Johnson & Johnson, Merck, Moderna, Novavax and Pfizer, and European companies AstraZeneca, BioNTech, GlaxoSmithKline and Sanofi. BioNTech has partnered with Pfizer on one of the vaccines now in the final round of human testing.
The pledge reads:
“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 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.
“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 authorization 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.
- Work to ensure a sufficient supply and range of vaccine options, including those suitable for global access.
- 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.”
The announcement comes amid worries that the U.S. Food and Drug Administration will be under political pressure to approve a vaccine before tests to prove it is safe and effective are finished.
Meanwhile, public health officials worry that if many Americans don’t get the vaccine, it will be harder to reduce the spread of COVID-19.