Biopharma CEOs pledge commitment to safe vaccines

By The Science Advisory Board staff writers

September 8, 2020 -- The CEOs from nine biopharmaceutical companies have pledged to remain committed to upholding the integrity of the scientific process as they work toward global regulatory filings and approvals for COVID-19 vaccines.

Leaders from AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer, and Sanofi signed the following pledge:

We, the undersigned biopharmaceutical companies, want to make clear our ongoing 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.

Experts draw lessons from FDA's hydroxychloroquine EUA controversy
Public health and regulatory experts advocated for changes to the U.S. Food and Drug Administration (FDA) emergency use authorization (EUA) process in...
The race is on to create a COVID-19 vaccine. But what next?
Fears of continuing waves of infection with the SARS-CoV-2 virus have helped trigger an accelerated effort among drug developers to bring a coronavirus...
FDA issues guidance on COVID-19 vaccine licensure
The U.S. Food and Drug Administration (FDA) has provided new regulatory guidance for developers of vaccines for COVID-19. The guidance lays out the agency's...

Copyright © 2020 scienceboard.net


Conferences
Connect
Science Advisory Board on LinkedIn
Science Advisory Board on Facebook
Science Advisory Board on Twitter