Nine Leading Biopharmaceutical Companies Issue Joint Commitment to Uphold Scientific Integrity in COVID-19 Vaccine Development

Today, the CEOs of nine companies—AstraZeneca, BioNTech, GSK, Johnson & Johnson, MSD, Moderna, Novavax, Pfizer, and Sanofi—jointly signed a commitment to uphold the integrity of the scientific process as they advance global regulatory submissions and approvals for the first COVID-19 vaccines.

These nine companies have collectively developed more than 70 innovative vaccines, helping to eradicate some of the world’s most complex and deadly public health threats.

The original text of the commitment signed by nine chief executive officers is as follows:

We (the undersigned biopharmaceutical companies) wish to clarify our ongoing commitment to developing and testing potential COVID-19 vaccines in accordance with high ethical standards and sound scientific principles.

The safety and efficacy of vaccines (including any potential COVID-19 vaccines) are reviewed and determined by expert regulatory agencies around the world, such as the U.S. FDA. The FDA has established clear guidelines for the development of COVID-19 vaccines and defined specific criteria for their potential authorization or approval in the United States. These FDA guidelines and standards are grounded in scientific and medical principles necessary to clearly demonstrate the safety and efficacy of potential COVID-19 vaccines. More specifically, the FDA requires that scientific evidence supporting regulatory approval must derive from large, high-quality clinical trials that are randomized and observer-blinded, and it expects these trials to include a substantial number of participants drawn from broadly diverse populations.

In accordance with guidelines from expert regulatory agencies such as the FDA for the development of COVID-19 vaccines, and in compliance with current standards and specifications, with a focus on public health interests, we commit to:

The safety and well-being of vaccinated individuals remain our top priority.

Uphold high scientific and ethical standards in the conduct of clinical trials and the stringency of manufacturing processes.

Regulatory applications or Emergency Use Authorization (EUA) applications are submitted only after Phase 3 clinical trials, which meet the requirements of expert regulatory agencies (such as the FDA), have demonstrated the safety and efficacy of the candidate vaccine.

Strive to ensure adequate vaccine supply and a diverse range of vaccine options, including those suitable for global use.

We believe this commitment will help ensure public confidence in the rigorous scientific and regulatory processes for evaluating and approving COVID-19 vaccines.

References:

[1] Biopharma Leaders Unite to Stand With Science. Retrieved September 8, 2020, from https://www.businesswire.com/news/home/20200908005277/en

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