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E&C GOP Leaders Seek Missing Info on Lab Capacity for Development of COVID-19 Vaccines, Therapeutics, and Diagnostics


11.18.20

Washington, D.C. – Energy and Commerce Committee Republican Leader Greg Walden (R-OR), Oversight and Investigations Subcommittee Republican Leader Brett Guthrie (R-KY), and Health Subcommittee Republican Leader Dr. Michael Burgess (R-TX) sent a letter to Centers for Disease Control and Prevention (CDC) Director Robert R. Redfield, M.D. to ask the CDC for complete and updated information on domestic BioSafety Level (BSL)-3 and Animal BSL (ABSL)-3 laboratory capacity with the ability to conduct preclinical animal model research for COVID-19 vaccines, therapeutics, and diagnostics development.

Ranging from BSL-1 to BSL-4, with BSL-4 posing the highest risk to biosafety, there are four main biosafety levels for laboratory research on biological agents set by the CDC and the National Institutes of Health (NIH). Research on COVID-19 requires laboratories with BSL-3 or greater capabilities. Currently, there is not comprehensive data available with regard to current BSL-3 and ABSL-3 lab capacity, despite ongoing increased demand due to the COVID-19 public health emergency. Worse, because there is no comprehensive information on capacity, the limited capacity of ABSL-3 labs cannot be managed effectively.

“The lack of information on BSL-3 laboratory capacity is of concern because it may be contributing to delays and bottlenecks in preclinical COVID-19 research. Although the BSL-3 laboratory capacity is not fully known, the extraordinary demand for COVID-19 preclinical research may have overwhelmed the known, available capacity,” wrote Walden, Guthrie, and Burgess.

Evidence suggests that limited or unknown lab capacity may be contributing to preclinical research delays. For example, in the letter the E&C Republicans quote Deborah Fuller, chief of infectious diseases at the Washington National Primate Research Center, who said, “[t]he real bottleneck is the access to the ABSL 3…(Scientists) are ready and their products are ready, but now they’re twirling their thumbs.” The E&C Republicans also cite Albert Bourla, Pfizer’s CEO, having worries about laboratory capacity delaying the clinical-trial process. Despite reporting requirements on laboratory capacity in legislation signed into law and previous federal government attempts at acquiring this information, there is still a lack of comprehensive information on domestic laboratory capacity with BSL-3 and ABSL-3 capabilities.

“It is critical for the nation’s response to the pandemic to have the best understanding of the totality of such research assets in the U.S. in order to improve access for researchers, maximize research opportunities for identifying medical advances for COVID-19, bring in any underutilized laboratories to help relieve burdens on overworked research entities, and understand through traditional gap analysis whether there is appropriate high-containment laboratory capacity for biodefense strategic planning. Because the CDC has been a primary source of data for U.S. government assessments for laboratory capacity, we would appreciate the CDC’s assistance to explore ways for obtaining comprehensive data on BSL-3 laboratories and ABSL-3 laboratories in the U.S.,” continued Walden, Guthrie, and Burgess.

Click HERE to read the letter to the CDC.

Press Release