COVID-19 Vaccine Makers Sign Historic Safety Pledge Upholding Integrity of Scientific Process
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By HospiMedica International staff writers Posted on 09 Sep 2020 |
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Image: COVID-19 Vaccine Makers Sign Historic Safety Pledge Upholding Integrity of Scientific Process (Photo courtesy of Pfizer)
The CEOs of AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer, and Sanofi, have made a historic pledge to the world, outlining a united commitment to uphold the integrity of the scientific process as they work towards potential regulatory filings and approvals of the first COVID-19 vaccines.
By signing the pledge, the biopharmaceutical companies aim to make clear their ongoing commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles. 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, the companies have pledged to:
• Always make the safety and well-being of vaccinated individuals their 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.
The companies believe that the 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.
By signing the pledge, the biopharmaceutical companies aim to make clear their ongoing commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles. 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, the companies have pledged to:
• Always make the safety and well-being of vaccinated individuals their 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.
The companies believe that the 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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