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COVID-19: Testing Advancements, Vaccine Development

The National Institute of Allergy and Infectious Diseases (NIAID) within the National Institutes of Health (NIH) has launched the ACTIV-5 Big Effect Trial, which will test experimental therapies to treat COVID-19. The phase 2 adaptive, randomized, double-blind, and placebo-controlled trial will enroll adult volunteers in up to 40 sites across the United States.

The trial will test two monoclonal antibodies — lab-made versions of proteins that the immune system naturally produces in response to pathogens — in conjunction with remdesivir, an antiviral drug that has shown to benefit hospitalized COVID-19 patients.

Risankizumab, developed by Boehringer Ingelheim and AbbVie, was approved in 2019 to treat plaque psoriasis. The second monoclonal antibody, lenzilumab, was developed by Humanigen and also is being tested independently in a phase 3 COVID-19 study and in a phase 1b/2 study as sequenced therapy with CAR-T treatments.

Each antibody-remdesivir combination will be compared to a placebo-remdesivir combination.

RADx Initiative Supports Six New COVID-19 Tests

NIH and the Biomedical Advanced Research and Development Authority (BARDA) awarded six contracts for COVID-19 test manufacturing through the Rapid Acceleration of Diagnostics (RADx) Initiative.

This is the third round of contracts awarded through the RADx Initiative, which currently supports 22 companies in the development and manufacturing of novel testing approaches. Funding for this round totals $98.35 million.

NIH and BARDA awarded three contracts for viral antigen tests, which can detect the virus that causes COVID-19 more rapidly than reverse transcription polymerase chain reaction (RT-PCR) tests, to:

  • Ellume USA LLC, in Valencia, Calif.;
  • Luminostics Inc., in Milpitas, Calif.; and
  • Quanterix, in Billerica, Mass.

The RADx Initiative also will provide financial support to three tests that use viral RNA detection, which is more accurate but also more time-consuming than antigen testing. These tests are produced by:

  • Flambeau Diagnostics, in Madison, Wis.;
  • Ubiquitome, in Auckland, New Zealand; and
  • Visby Medical, in San Jose, Calif.

FDA Issues COVID-19 Vaccine Brief

Ahead of the Vaccines and Related Biological Products Advisory Committee’s Oct. 22 meeting, the Food and Drug Administration (FDA) released a brief on vaccine development, authorization, and licensure.

The agency in June released industry guidance with recommended studies to evaluate the safety and efficacy of COVID-19 vaccine candidates, and the committee will discuss at the Oct. 22 meeting the need for additional studies focused on special populations, such as children and pregnant people. Additionally, the committee will discuss the need for post-marketing safety studies following the approval of a Biologics License Application for a vaccine candidate, as well as ongoing assessment of vaccine risks and benefits.

CMS Issues Cease-and-Desist Letters for CLIA Certification

Every facility that conducts COVID-19 testing is considered a laboratory and must be certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).

The Centers for Medicare & Medicaid Services (CMS) has issued 171 cease-and-desist letters to health care facilities operating without proper CLIA certification. Of the 171 letters issued, 34 percent went to facilities testing without a CLIA certificate, and 66 percent went to facilities conducting testing outside of the scope of a CLIA certificate. These laboratories must attest to CMS that they have ceased testing.

CMS in September issued a quick-start guide for facilities seeking CLIA certification.

Visit the America’s Essential Hospitals coronavirus resource page for more information about the outbreak.

Contact Senior Director of Policy Erin O’Malley at eomalley@essentialhospitals.org or 202.585.0127 with questions.

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About the Author

Emily Schweich is a senior communications associate for America's Essential Hospitals.

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