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Associates in Action: Biopharma Leaders

Biopharma Leaders Pledge to Scientific Standards for a Potential COVID-19 Vaccine

By Julianne Stahl, The Council of State Governments

Associates in Action articles highlight CSG Associates’ philanthropic efforts and public-private partnerships throughout the states.

As part of the global race to a vaccine, nine biopharmaceutical industry leaders have signed a united safety pledge to uphold the scientific and safety standards of their immunization trial processes as they work towards potential regulatory filings and approvals of the first COVID-19 vaccines. Five of the participating companies are CSG Associates, including GlaxoSmithKline, Johnson & Johnson, Merck, Pfizer and Sanofi.

These biopharma companies have committed to ensuring the safety and efficacy of vaccines, including any potential vaccine for COVID-19, which will be reviewed and determined by expert regulatory agencies around the world, such as the United States Food and Drug Administration (FDA).

Following guidance from expert regulatory authorities such as the FDA regarding the development of COVID-19 vaccines, consistent with existing standards and practices, and in the interest of public health, these corporate leaders have 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 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.

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.