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In all, the nine companies have developed more than 70 innovative vaccines that have helped eradicate some of the world's most complex and deadly public health threats.
commitment signed by the nine CEOs reads: "We (the biopharmaceutical companies signed below) want to clarify our ongoing commitment to develop and test potential new crown vaccines in accordance with high ethical standards and reliable scientific guidelines."
safety and ability of vaccines, including any potential new crown vaccines, are reviewed and determined by expert regulators around the world, such as the FDA.
FDA has developed clear guidelines for the development of new crown vaccines and clear criteria for their potential authorization or approval in the United States.
FDA guidelines and standards are based on the scientific and medical principles needed to clearly demonstrate the safety and effective vaccine.
more specifically, the FDA requires regulatory approval of scientific evidence from large, high-quality clinical trials that are randomized and blind to observers, and expects clinical trials to include a large number of subjects from a wide range of different populations.
in line with guidelines from expert regulators such as the FDA on the development of new crown vaccines, in line with existing standards and norms, with a view to the public health interest, we are committed to " always keeping the safety and well-being of vaccinated people a top priority."
adhere to high scientific and ethical standards in the conduct of clinical trials and the strictness of production processes.
only submit regulatory or emergency use authorization (EUA) applications after demonstrating the safety and effectiveness of candidate vaccines through Phase 3 clinical trials that meet the requirements of an expert regulatory body, such as the FDA.
efforts to ensure adequate vaccine availability and vaccine options, including vaccines suitable for global use.
we believe this commitment will help ensure public confidence in the rigorous scientific and regulatory process for evaluating and approving new crown vaccines.
resources: Biopharma Leaders Unite to Stand With Science. Retrieved September 8, 2020, from.