October 13, 2021

Warren, Merkley, and Jayapal Lead Colleagues in Urging the Biden Administration to Review Moderna-HHS Contract and Expand Global COVID-19 Vaccine Access

The Moderna-HHS contract may give the federal government legal authority to access and share the ingredient list and manufacturing instructions for Moderna’s COVID-19 vaccine

Text of Letter (PDF)

Washington, D.C. — United States Senators Elizabeth Warren (D-Mass.) and Jeff Merkley (D-Ore.) and United States Representative Pramila Jayapal (D-Wash.) sent a letter to Dr. David Kessler, the Chief Scientific Officer for the COVID-19 Response, and Dr. Gary Disbrow, the Director of the Biomedical Advanced Research and Development Authority (BARDA), raising concerns about the need to accelerate global vaccine manufacturing and expand access to COVID-19 vaccines around the world. BARDA is a component agency of the Department of Health and Human Services (HHS). As of September 30, less than 10 percent of the people living in poor nations have been fully vaccinated. The lawmakers are urging the Biden administration to take bold steps to dramatically expand global COVID-19 vaccine access and manufacturing capabilities as quickly as possible to produce the estimated 11 billion doses needed to vaccinate 70 percent of the world’s population.

“Despite receiving huge sums of public funding from American taxpayers, Moderna has refused calls to share its technology, including from the U.S. government,” wrote the lawmakers. 

“(However)”, the lawmakers continued, “the contract Moderna entered into with the Biomedical Advanced Research and Development Authority (BARDA) may give the federal government legal authority to access and share the ingredient list and manufacturing instructions for Moderna’s COVID-19 vaccine.” 

Moderna has disproportionately benefited from federal resources to support the development of safe and effective COVID-19 vaccines, yet has so far refused calls to share its technology. In addition to receiving significant federal resources to assist in vaccine development, Moderna has received nearly $10 billion in federal government funding to boost its manufacturing capacity, execute large-scale clinical trials, and deliver vaccines.

Dramatically expanding global COVID-19 vaccine manufacturing is critical to meeting President Biden’s goal of vaccinating roughly 70 percent of the world’s population and ending the global pandemic. However, without cooperation from Moderna, manufacturing facilities that stand ready to help will be forced to spend precious time trying to replicate existing mRNA technology.

Under the contract Moderna entered into with BARDA, the federal government may have legal authority to access and share the ingredient list and manufacturing instructions for Moderna’s COVID-19 vaccine. Specifically, the contract grants BARDA “unlimited rights to data funded under this contract pursuant to the [the Federal Acquisition Regulations (FAR)] Clause 52.227-14.” Under FAR, data is defined to include “recorded information, regardless of form or the media on which it may be recorded,” as well as “technical data” – a broad definition that appears to include all key information needed to produce the vaccine.

The bicameral letter is signed in the Senate by Senators Tammy Baldwin (D-Wisc.), Brian Schatz (D-Hawaii), Tina Smith (D-Minn.), and Sherrod Brown (D-Ohio); and in the House of Representatives by Representative Jan Schakowsky (D-Ill.), Lloyd Doggett (D-Texas), Mark Pocan (D-Wisc.), Maxine Waters (D-Calif.), and Raja Krishnamoorthi (D-Ill.).

The lawmakers have requested responses to their questions no later than October 26, 2021. 

Senator Warren has repeatedly called for greater investments in global COVID-19 vaccine manufacturing:

  • Last month, Senators Warren, Tina Smith (D-Minn.), and their colleagues urged the Biden administration to ramp up vaccine production in low- and middle-income countries. 
  • In July, Senator Warren and Congresswoman Pramila Jayapal (D-Wash.), and their colleagues called on Congress to provide $34 billion for global vaccine manufacturing in the reconciliation package. She also called on Moderna, Pfizer, and Johnson & Johnson to expand global vaccine access. 
  • Senator Warren, Senator Merkley, and Rep. Jayapal also introduced the Nullifying Opportunities for Variants to Infect and Decimate (NOVID) Act to rapidly scale up the production of vaccines. 
  • Senator Warren successfully pushed the Biden administration to support a temporary waiver of some Trade-Related Aspects of Intellectual Property Rights (TRIPS) rules.

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