CEOs of the leading pharmaceutical companies are reassuring the public they are committed to proving the safety and efficacy of their potential coronavirus vaccines.
Among the nine companies include AstraZeneca, Johnson & Johnson, Moderna, Inc., and Pfizer Inc.
They issued a statement on Tuesday to outline a “united commitment to uphold the integrity of the scientific process” as they strive toward the “potential global regulatory filings and approvals” of coronavirus vaccines.
The companies noted the safety and efficacy of vaccines are reviewed and determined by agencies including the United States Food and Drug Administration (FDA).
According to the statement, the FDA requires evidence for regulatory approval to 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.”
The companies pledged to prioritize the well-being of individuals receiving the vaccine. They also promised to follow scientific and ethical standards in clinical trials and the manufacturing process.
Additionally, they will not submit the vaccine for approval or emergency use authorization until they prove it is safe and effective through a Phase 3 clinical study.
The CEOs said they will provide a variety 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,” they said.
The statement comes amid concerns the political pressure could lead to the distribution of vaccine before one is proved to be safe and effective.
President Donald Trump previously said a vaccine would be available soon, possibly before the November election, as IJR previously reported.
Some are skeptical of Trump’s promise there will be a vaccine in record time, including Democratic vice presidential nominee Kamala Harris, as IJR previously reported.
She told CNN on Sunday she “would not trust” Trump’s word on a vaccine.
