simon2579/iStockBy CATHERINE THORBECKE, ABC News
(NEW YORK) — A coalition of nine pharmaceutical chief executives issued a joint pledge Tuesday that they will not rush the development of a COVID-19 vaccination for political purposes and will not seek approvals until the vaccines have gone through Phase 3 clinical trials.
The unusual joint move from nine industry leaders comes after the U.S. Centers for Disease Control and Prevention notified states to be ready to distribute a vaccine to certain groups just two days before the presidential election, stoking concerns that the Trump administration may be putting political pressure on companies and health officials to fast-track vaccine approvals ahead of the November vote.
The leaders of AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer, and Sanofi pledged in the joint statement that they will follow “high ethical standards and sound scientific principles” in their vaccine developments.
The pledge added that all vaccines have to go through strict regulatory approvals established by the U.S. Food and Drug Administration and a COVID-19 vaccine is no exception. Moreover, the CEOs added that the safety and well-being of vaccinated individuals will be their “top priority.”
Finally, the pledge stated that the vaccine makers will only submit for regulatory approval or emergency use authorization of the vaccine after its safety and efficacy has been demonstrated through a Phase 3 clinical study. The Phase 3 study refers to a large scale group (30,000 patients) and aims to test the effectiveness and long-term safety in multiple populations.
“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,” the CEOs stated.
Through Operation Warp Speed, Trump’s effort to accelerate production of a coronavirus vaccine, some of the most promising vaccine candidates will be selected to be developed at risk, meaning they will be manufactured while they are still in development even if they don’t end up being used.
Congress has directed almost $10 billion to this operation and companies involved include some signatories of Tuesday’s pledge such as Novavax, AstraZeneca, Moderna, Johnson & Johnson, Pfizer and Sanofi.
The goal of the public-private effort is to deliver 300 million doses of a safe vaccine by January 2021.
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