Drugmakers racing to produce Covid-19 vaccines pledged to avoid shortcuts on science as they face pressure to rush a shot to market.
In an unusual public letter, the companies agreed to submit the vaccines for clearance only when they’re shown to be safe and effective in large clinical studies. The chief executive officers of nine frontrunners in the push for a coronavirus inoculation signed the pledge: AstraZeneca Plc, BioNTech SE, GlaxoSmithKline Plc, Johnson & Johnson, Merck & Co., Moderna Inc., Novavax Inc., Pfizer Inc. and Sanofi.
“In the interest of public health, we pledge to always make the safety and well-being of vaccinated individuals our top priority,” the executives wrote.
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.
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