September 9, 2020
On September 7, nine pharmaceutical companies issued a rare joint pledge—intended to reassure the American public about the safety and efficacy of the coronavirus vaccines that currently are under development.
The statement from the top drug companies working on COVID-19 vaccines—including Pfizer, AstraZeneca, and Moderna—comes amid fears that President Donald Trump will continue to place pressure on the industry to speed up the vaccine approval process without proper oversight, and doubts among the public about taking a vaccine, The Hill reports.
The joint pledge states that the companies will not seek Food and Drug Administration (FDA) approval for their vaccines until a rigorous phase 3 clinical trial shows that it is safe and that it works.
The companies pledged they would “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.”
Highlighting the fears of political interference, Trump on Monday floated the idea of having a vaccine before Election Day on November 3. “We’re going to have a vaccine very soon. Maybe even before a very special date. You know what date I’m talking about,” he said at a news conference.
Trump has put pressure on the FDA before, saying that the “deep state” at the agency was throwing up roadblocks before the agency issued an emergency authorization for a coronavirus treatment known as convalescent plasma.
According to The Hill, FDA Commissioner Stephen Hahn also has offered reassurances that his agency will base vaccine decisions only on science and not on politics.
But the statement from the pharmaceutical companies is an illustration of how deep the fears are about politicization of the process and the need for companies to try make their own reassurance about science guiding the process.
Research contact: @thehill