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U.S. Department of Health and Human Services

BARDA’s Novel Coronavirus Medical Countermeasure Portfolio

On January 31, 2020, HHS Secretary Alex Azar declared a nationwide Public Health Emergency in response to the novel coronavirus outbreak. As part of the overarching federal response, BARDA expanded existing partnerships to develop medical countermeasures to enhance health security and protect against 2019 novel coronavirus infections (COVID-19).

Diagnostics

  • Hologic, Inc. is developing a molecular diagnostic test for COVID-19 that is being designed for use in conjunction with its approved Panther Fusion system. This technology can be used to process hundreds of tests in 24 hours and can provide results to clinicians in less than three hours. The Panther Fusion system provides complete sample-to-result automation with minimal user interaction and offers a broad menu of FDA-cleared tests to detect common respiratory infections.
  • Qiagen LLC is developing a test for COVID-19, QIAstat-Dx RPS2, to be added to the QIAstat-Dx Respiratory Panel. The QIAstat-Dx Respiratory Panel is used to run FDA-cleared tests for 21 other respiratory pathogens.  The device features easy-to-use molecular testing with novel workflows.
  • DiaSorin Molecular LLC is advancing a molecular diagnostic test for their FDA-cleared LIAISON MDX instrument. This technology uses a sample-to-answer approach with minimal operator input and hundreds of the instruments are in use in large commercial and public health laboratories around the country.
  • Mesa Biotech is developing a rapid, point-of-care diagnostic test for 2019 novel coronavirus that is intended for clinical or lab use. The test will use the Accula Dock instrument that has 510(k) clearance and a Clinical Laboratory Improvement Amendment (CLIA)-waiver from FDA.
  • Cepheid is developing a rapid diagnostic test for COVID-19. The test is developed for use on Cepheid’s GeneXpert diagnostic platform which is used world-wide to test for other infections, such as tuberculosis, HIV, Group A Streptococcus (strep), and influenza. The COVID-19 test can provide results within 45 minutes, and is designed for use in clinical and hospital laboratories.
  • Luminex Corporation is working with BARDA on the rapid development of the diagnostic test called the NxTAG CoV Extended Panel for COVID-19. The test uses RNA to detect the presence of the SARS-COV-2 virus and is intended for use with the company’s IVD MAGPIX® molecular diagnostic system. Test results are available in less than four hours. The test received FDA Emergency Use Authorization on March 27, 2020.

Vaccines

  • Sanofi Pasteur is developing a novel coronavirus vaccine candidate using its recombinant DNA platform technology that BARDA has previously supported for production of influenza vaccines. This technology produces an exact genetic match to proteins of the coronavirus and is designed for more rapid production than traditional manufacturing methods.
  • Janssen Research & Development, part of Johnson & Johnson, is partnering with BARDA to help accelerate an investigational COVID-19 vaccine into clinical evaluation. Janssen will use the same approach used to develop and manufacture its investigational Ebola vaccine, which was supported by BARDA and is being used in the Democratic Republic of the Congo as part of the response to the current Ebola outbreak and to prevent spread of the disease to Rwanda.
  • Moderna is partnering with BARDA to speed the development and manufacturing of SARS-CoV-2 mRNA-1273, a 
     vaccine to prevent COVID-19.  BARDA will suppport Phase 2 and 3 clinical trials of the vaccine. 


Therapeutics

  • Regeneron Pharmaceuticals is developing multiple monoclonal antibodies that, individually or in combination, could be used to treat COVID-19. Under its expanded agreement with BARDA, Regeneron is leveraging its existing monoclonal antibody discovery platform called VelocImmune, part of the company's VelociSuite technology, to develop therapeutic products to treat COVID-19 infections. VelociSuite was used to develop a promising investigational three-antibody therapeutic, which was deployed to treat Ebola in the most recent outbreak in the Democratic Republic of the Congo, as well as an investigational therapeutic to treat Middle East Respiratory Syndrome coronavirus (MERS-CoV).
  • Janssen Research & Development is developing treatments for COVID-19 infections. BARDA will collaborate with Janssen to screen library of approved therapeutics as well as investigational therapeutics that have completed some clinical trials where basic safety and pharmacology data are available for these compounds. If screening is promising, candidates then could be considered for further, accelerated development, including assessment in additional clinical studies.

  • This page last reviewed: March 31, 2020