Members of Congress Demand Transparency of Operation Warp Speed
In an official letter, members of Congress demanded answers about Operation Warp Speed, including vaccine candidates, scientific review, clinical trials, and how funding will support future COVID-19 vaccines.
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By - Twenty-four members of Congress demand increased oversight and transparency of Operation Warp Speed vaccine development program in an official letter to HHS Secretary Alex Azar.
In the letter, the lawmakers asked Azar to answer questions surrounding specificity of vaccine candidates, the parameters of scientific review, affordability of therapeutics and vaccines, and how clinical trials will be conducted.
Specifically, they intend to uncover how the more than $6.6 billion in taxpayer funds going to private pharmaceutical companies through Operation Warp Speed will support development of an affordable vaccine for COVID-19.
The billions pledged to pharmaceutical companies were made without making public the full scope of the project or how companies receiving federal funding were selected, the Congress members said.
One of the companies that received funding through Operation Warp Speed was Pfizer.
Last week, HHS and Department of Defense (DoD) made an agreement with Pfizer to begin large-scale production and nationwide delivery of 100 million doses of its COVID-19 vaccine in the US.
Under the agreement, the government will pay Pfizer and BioNTech $1.95 billion upon the receipt of the first 100 million doses and the government can acquire an additional 500 million doses for Americans.
Pfizer will deliver doses in the US if the vaccine receives Emergency Use Authorization (EUA) or licensure from FDA, after showing safety and efficiency in a Phase 3 clinical trial.
Other companies that have received funding from the initiative include Johnson & Johnson, Emergent BioSolutions, Moderna, AstraZeneca, and Novavax.
“[T]he Administration has failed to lay out how these candidates have been selected to receive federal support nor made public the names of all the companies being funded under OWS,” Congress members wrote in the letter.
In the recent letter, one of the most significant concerns was that many of these companies that received funding plan to utilize experimental techniques, and one has never produced an FDA approved product before.
“Moderna Therapeutics, the company with a COVID-19 vaccine frontrunner, has never had a FDA-approved product before. Top scientific experts on the National Institutes of Health’s (NIH) Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) committee have also stated that they were not consulted during the selection process of these candidates nor asked to vet their products” they said in the letter.
Additionally, lawmakers voiced concerns surrounding affordability of therapeutics and vaccines developed to fight COVID-19 under Operation Warp Speed and BARDA contracts.
Lawmakers requested that Azar prohibit exclusive licensing in Operation Warp Speed contracts for vaccines and drugs that receive federal funding.
This will ensure the medicines are accessible to everyone and to reflect the investment of taxpayers.
“Every American understands the urgency to develop a vaccine to counter the devastating effects COVID19 has had on this country, and to return our nation and the world to a more normal footing” the Congress members said.
“But we must do so safely and transparently. We look forward to your response and working together on this issue.”
Back in May, the Trump Administration released framework and leadership for Operation Warp Speed, the public-private partnership to facilitate the development, manufacturing, and distribution of COVID-19 countermeasures.
So far, Congress has directed almost $10 billion to Operation Warp Speed through supplemental funding, including the CARES Act
Lawmakers have also appropriated other flexible funding. Congress has designated over $6.5 billion for countermeasure development through BARDA, along with $3 billion for NIH research.
The administration appointed Moncef Slaoui, MD, as chief executive and General Gustave F. Perna as chief operating officer.
“President Trump's vision for a vaccine by January 2021 will be one of the greatest scientific and humanitarian accomplishments in history, and this is the team that can get it done," Azar said in the May press release.
