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Tuesday, October 20, 2020
Open Letter Urges Transparency in COVID-19 Vaccine Clinical Trials
With the assistance of Yale Law School’s Media Freedom and Information Access (MFIA) Clinic, a nationwide group of researchers, scholars, professionals, and activists in the fields of medicine, public health, and health policy, have issued an open letter urging greater transparency into the design of clinical trials for COVID-19 vaccine candidates. The letter represents the latest effort of a team of law students and faculty from Yale Law School, the Yale School of Public Health, and Yale School of Medicine, who have been advocating throughout the fall for the release of information related to the federal pandemic response, including vaccine trial information and emergency use authorization standards.
The open letter is addressed to Secretary Alex M. Azar II of the Department of Health and Human Services (HHS) and copied to National Institutes of Health (NIH) Director Collins, National Institute of Allergy and Infectious Diseases (NIAID) Director Anthony Fauci, and the CEOs of six vaccine manufacturers. The signatories express worry about the growing number of Americans who profess to be nervous about a politicized or rushed vaccine. They argue that additional transparency is essential to improving public confidence in any vaccine eventually authorized for use by the Food and Drug Administration (FDA), in addition to protecting the long-term reputation of the nation’s public health agencies. It will also allow researchers otherwise blocked from doing so to better contribute to the high-quality scientific analysis of the vaccine trial protocols.
The signatories applaud the four pharmaceutical companies that have taken the significant step of releasing the current versions of their clinical trial protocols in the past month. They believe that the spirit of these disclosures — which have already led to positive media coverage for the companies and independent scientific review of their trials — should be carried forward into additional disclosures that, together, could provide a more complete picture of the scientific basis for any eventual vaccine approval. COVID-19 vaccine development under “Operation Warp Speed,” the signatories point out, has been aided by large public investments. The American people, in turn, deserve the benefit of transparency, and the public trust and scientific inquiry it can foster, according to the letter.
“The group’s aim in this letter is to push HHS to meet this unprecedented moment of crisis and to head off the public’s growing concern about Operation Warp Speed vaccines and political influence over scientific decision-making at HHS and the FDA,” said Sam Aber ’22, a member of the MFIA Clinic. “Secrecy breeds mistrust. Especially when billions of dollars of public money are involved — both in funding the OWS studies and in advance purchase agreements with pharmaceutical companies — we think enabling independent scientific analysis of the trials being used to evaluate the vaccines is absolutely essential.”
The MFIA Clinic at Yale Law School is dedicated to increasing government transparency, defending the essential work of news gatherers, and protecting freedom of expression through impact litigation, direct legal services, and policy work.