Revamped Senate stimulus bill would provide $27B to HHS to combat pandemic
BioCentury is providing this story for free given the urgent need for information about the COVID-19 crisis. For more analysis, sign up for our daily email.
The U.S. Senate’s latest COVID-19 stimulus bill would appropriate $340 billion to support local and national agencies to combat the pandemic, including billions for biopharma R&D.
HHS’s Public Health and Social Services Emergency Fund would receive $27 billion in funding to develop countermeasures and vaccines, with platform technologies with U.S.-based manufacturing capabilities given priority, according to a version of the Coronavirus Aid, Relief, and Economic Security (CARES) Act released by Sen. Patrick Leahy (D-Vt.), vice chairman of the Senate Appropriations Committee.
The appropriations portion of CARES is part of a $2 trillion bailout that as of late Wednesday was still awaiting a vote in the Senate.
The funds would also go towards purchasing therapeutics, diagnostics, vaccines and medical supplies. The bill contains similar price assurances as the $7.8 billion coronavirus spending legislation signed into law at the beginning of month. That appropriations package had allocated $3.4 billion to the emergency fund (see “House’s COVID-19 Spending Bill”).
Vaccines, therapeutics and diagnostics must be purchased “in accordance with guidance on fair and reasonable pricing.” The legislation would also enable the HHS secretary to take measures to ensure that products developed with appropriated funds “be affordable in the commercial market.”
Within the emergency fund, the Biomedical Advanced Research and Development Authority (BARDA) would receive $3.5 billion to manufacture and purchase vaccines, therapeutics, diagnostics and small molecule APIs.
BARDA has already begun funding COVID-19 programs, starting with trials of IL-6 inhibitors Kevzara sarilumab from Sanofi (Euronext:SAN; NASDAQ:SNY) and Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and Actemra tocilizumab from Genentech Inc. Both candidates, which will be evaluated in patients with later-stage disease and respiratory deterioration, entered pivotal studies in the past two weeks (see “BARDA Throws Weight Behind Kevzara, Actemra Studies”).
BARDA has also helped fund the recombinant nanoparticle vaccine platform of Novavax Inc. (NASDAQ:NVAX), which is turning its technology towards developing a COVID-19 vaccine (see “Novavax’s Flu Data Showcase Vaccine Platform’s Potential”).
Manufacturing and the supply chain are priorities in the bill. A portion of BARDA’s $3.5 billion in funding could be used to construct or renovate U.S.-based next-generation manufacturing facilities, while an additional portion of the $27 billion would also be available for the “construction, alteration or renovation of non-federally owned facilities for the production of vaccines, therapeutics, and diagnostics” if it would be necessary “to secure sufficient amounts of such supplies.”
Additionally, $16 billion of the emergency fund would be allocated for the Strategic National Stockpile, and $1.5 billion could be used to contract the National Academies of Sciences, Engineering and Medicine to report on the security of the U.S. medical product supply chain.
Other biomedical appropriations include the NIH and the Department of Defense. NIH would receive $945 million to study the prevalence and transmission of COVID-19, as well as to develop novel diagnostics and countermeasures to prevent the disease. DoD would receive $415 million for military medical research programs to test vaccines and antiviral pharmaceuticals.
The bill would also appropriate $80 million for FDA to address shortages of critical medicines and grant emergency use authorizations for COVID-19 tests (see “FDA Authorizes First COVID-19 Point-of-Care Diagnostic”).
The funds would also go towards the agency’s pre- and post-market work on medical countermeasures, therapies, vaccines and research.
A total of $4.3 billion is earmarked for CDC to support federal, state and local public health agencies. The figure includes $1.5 billion in flexible funding, which could be used to purchase and distribute diagnostic test kits and to support laboratory testing.
While the initial version of the CARES Act introduced last week by Senate Republic leaders included the Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms (DISARM) Act, the legislation was not included in the updated bill (see “Coronavirus Bill Includes Antibiotic, Net Operating Loss Carryback”).
Further analysis of the coronavirus crisis can be found at https://www.biocentury.com/coronavirus.