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September 15, 2020

King, Colleagues to FDA: Make Vaccine Decision Process Public

"Full transparency throughout the review and authorization process is essential to countering real or perceived politicization.”

WASHINGTON, D.C. – U.S. Senator Angus King (I-Maine) joined his colleagues in sending a letter to the U.S. Food and Drug Administration (FDA), calling on the agency to commit to full transparency in the COVID-19 vaccine review process amidst mounting political pressure to approve a vaccine before Election Day. The lawmakers expressed concern that the Trump Administration has placed political expediency over the research and testing process, and the senators urged the FDA to ensure transparency in vaccine review efforts in order to maintain public trust. 

"We write to seek your commitment that the Food and Drug Administration's (FDA) review process for potential vaccinations against the coronavirus disease 2019 (COVID-19) will be fully transparent and accountable," wrote the Senators. "We are encouraged by the development of a number of vaccine candidates, and we share the FDA's goal of facilitating ‘the timely development of safe and effective vaccines to prevent COVID-19.’ However, we are concerned that the accelerated timeline and intense political pressure around the vaccine development process could have the unintended consequence of undermining public confidence in the safety and quality of an eventual vaccine."

More than 100 vaccines against COVID-19 are currently in development worldwide, with 37 in human clinical trials, proceeding at an unprecedented pace. To address public concerns that the rapid speed of vaccine development could compromise the integrity of the review process, the FDA issued guidelines in June 2020 to assist in the clinical development and licensure of vaccines for COVID-19. However, the Administration has continuously applied political pressure on the agency — including promising that a vaccine will be approved by the end of 2020, as well as indicating that a vaccine could be in place before Election Day. The Centers for Disease Control and Prevention (CDC) also recently announced that states should be prepared to distribute a vaccine by November 1, further raising concerns that the approval process will be rushed. Such recent statements made by the Trump Administration may risk undermining public confidence in the FDA unless the agency commits to expanding transparency even further.

Recent polling shows significant public skepticism about a future vaccine, including a recent poll which found that only 49% of American adults plan to accept a coronavirus vaccine, with 20% not planning to be vaccinated and 31% unsure. The same poll found that only 25% of Black Americans and 37% of Hispanic Americans plan to be vaccinated. 

Senator King has pushed the federal government to quickly and accurately act to make sure Americans have access to the available science and systems they need to stay healthy and stop the spread of the virus – including with his April recommendation to launch a government-wide testing effort to control the pandemic’s spread.  Last month, he wrote to Secretary of Health and Human Services (HHS) Alex Azar calling out the Administration for its ongoing political interference in the coronavirus response. In August, he introduced the COVID-19 Testing, Reaching, And Contacting Everyone (TRACE) Act to establish grants that could be used to support programs that use mobile health units or work through community-based organizations, provide coronavirus testing, conduct contact tracing, or offer assistance to individuals who quarantine after a positive test or contact with someone who has contracted the coronavirus. He also sent a letter urging Senate Appropriations leadership to fund a comprehensive program of testing, tracing, and supported isolation (TTSI). In April, Senator King wrote to the White House urging a focused effort to expand testing and tracing capabilities. Senator King has also called for a bipartisan effort to increase the federal government’s share of Medicaid dollars as well as reduce premiums for individuals who are eligible for coverage in the ACA exchanges. 

The full letter can be downloaded and read HERE 

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