Health policy experts urge US to release all COVID-19 vaccine clinical trial protocols

Maia Anderson -

More than two dozen health policy experts are urging HHS and other federal agencies as well as vaccine makers to disclose all information about clinical trials for COVID-19 vaccines and government contracts with drugmakers to supply the vaccines. 

In a letter dated Oct. 20, the experts said sharing such details would help ensure accountability and build public trust in a vaccine. 

"Transparency is one of the few tools at our disposal for increasing public trust in any vaccine proved safe and effective," they wrote. 

They applauded Pfizer, AstraZeneca, Moderna and Johnson & Johnson for releasing their trial protocols, but said more information can and should be disclosed. 

Among the information they're asking to be disclosed is all versions and amendments for each phase of all trials supported by Operation Warp Speed, the government's COVID-19 vaccine task force; clinical trial agreements with the National Institutes of Health; and any amendments for all ongoing and completed vaccine trials. 

"Though detailed trial design documents are not routinely shared in advance with researchers and the public, the stakes here are enormous and justify this step," they wrote. 

The letter is addressed to HHS, the NIH, the National Institute of Allergy and Infectious Diseases, and six drugmakers currently developing COVID-19 vaccines. 

Read the full letter here.

 

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