New York: Nine pharmaceutical companies on Tuesday issued a rare joint pledge seeking to reassure the public about the safety and efficacy of their potential vaccines for coronavirus.
The statement from the top drug companies working on coronavirus vaccines, including Pfizer, AstraZeneca and Moderna, comes amid fears of political pressure from President Trump on the vaccine approval process and doubts among the public about taking a vaccine.
The joint pledge states that the companies will not seek 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.”
The companies said they would “always make the safety and well-being of vaccinated individuals our top priority.”
Highlighting the fears of political interference, Trump on Monday floated the idea of having a vaccine before Election Day on Nov. 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.
FDA Commissioner Stephen Hahn has also 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.
An NPR-PBS NewsHour-Marist poll last month found that a significant portion of the public, 35 percent, said they would not take a coronavirus vaccine.
Pfizer CEO Albert Bourla reiterated Tuesday on NBC that his company’s vaccine could have results from the phase 3 trial by the end of October, a faster timeline than other experts have predicted.