WASHINGTON – U.S. Senate Democratic Whip Dick Durbin (D-IL) today released the following statement after receiving written responses from each pharmaceutical company with a vaccine candidate under Operation Warp Speed to letters Durbin had sent earlier this month:
“Americans seek a safe and effective COVID-19 vaccine that can hopefully return a sense of normalcy to their lives. But the proximity of the election cannot dictate the science. The President’s interference and political pressuring of our health experts is shaking public trust in the integrity of the vaccine development process. I asked the leading vaccine manufacturers how they will ensure no corners are cut. Their responses indicate the President’s preferred timeline does not reflect the reality of the scientific process and that we need more transparency.
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“Keeping clinical trial data and protocols secret and rushing a vaccine approval application to the FDA may satisfy the President, but it will not instill confidence in the American public.”
Major conclusions from the companies’ responses to Durbin include:
- Not one of the companies could corroborate the certainty with which President Trump has stated a vaccine would be ready in October.
- Not one of the companies fully committed to exclusively pursuing the more comprehensive Biologics License Application (BLA) pathway for full FDA approval, leaving the door open for the less rigorous Emergency Use Authorization (EUA) pathway, which has also been the subject of recent controversies.
- The responses from the vaccine manufacturers do not indicate any company is planning to present or directly participate in the FDA’s October 22 Advisory Committee meeting. One vaccine manufacturer has a senior scientific official sitting as a representative on this Advisory Committee.
- Moderna appeared to indicate there was a level of coordinating in clinical trial protocols across vaccine companies.
- There have been several instances of engagement with White House officials and vaccine makers, beyond their routine regulatory correspondence with FDA and the Department of Health and Human Services (HHS).
Earlier this month, Durbin sent letters to Moderna, AstraZeneca, Sanofi and GlaxoSmithKline, Merck, Pfizer, Novavax, and Janssen (part of Johnson & Johnson) asking how they plan to maintain scientific and data-based standards in the face of White House political pressure regarding the COVID-19 vaccine approval process. In his letters, Durbin highlighted how President Trump’s recent convalescent plasma and hydroxychloroquine controversies with the Food and Drug Administration (FDA) and comments stating a vaccine would be ready by Election Day have only increased public skepticism about the safety and efficacy of a potential COVID-19 vaccine and undermined credibility in the vaccine approval process. Durbin asked the companies to answer a series a questions in order to boost public confidence that no corners were being cut in the process.
Shortly after receiving Durbin’s letters, the companies released an advertisement pledging to uphold science in the approval process, and three of the companies made public their phase 3 clinical trial protocols.
