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BARDA to Buy $2B in Covid-19 Vaccines, Therapies

Syringe, pills, capsules

(Arek Socha, Pixabay)

7 July 2020. The federal health preparedness agency is spending more than $2 billion for developers to produce Covid-19 vaccines and treatments now in clinical trials. The Biomedical Advanced Research and Development Authority, or BARDA, with the U.S. Department of Defense, are contracting with Novavax Inc. in Gaithersburg, Maryland to complete clinical trials and produce large quantities of its Covid-19 vaccine, and Regeneron Pharmaceuticals Inc. in Tarrytown, New York, for production of its dual-antibody cocktail treatment for Covid-19 infections.

BARDA, an agency of the U.S. Department of Health and Human Services, invests in vaccines, therapies, and diagnostics to prepare for and respond to health security threats, including pandemics like Covid-19. The agency is contracting with Novavax in a deal valued at $1.6 billion for manufacturing, storage, and distribution, of 100 million doses of its vaccine code-named NVX-CoV2373 to protect against Covid-19 infections. The contract also funds late-stage clinical trials of NVX-CoV2373, enrolling some 30,000 participants, which if successful, would trigger the production phases of the contract.

Novavax creates vaccines protecting against infectious diseases with nanoscale particles of synthetic proteins designed specifically against the genetic code of their targets. The company says it infects cells from reproductive systems of the fall armyworm, a tropical insect, with engineered viruses that grow only in those cells. The engineered viruses are designed to express surface proteins that trigger an immune response, which make up the nanoscale particles in their vaccines. The company says NVX-CoV2373 creates antibodies that prevent binding of the virus’s characteristic spike protein with human receptors, thus preventing infections, and generates antibodies that neutralize the SARS-CoV-2 virus.

NVX-CoV2373 is in an early- and mid-stage clinical trial in Australia, testing the vaccine for safety and immune response among 131 participants age 18 to 59. The vaccine is being tested with and without Matrix-M, an adjuvant also made by Novavax. The company says Matrix-M boosts the immune response, allowing for lower doses of the primary vaccine.

“The pandemic has caused an unprecedented public health crisis,” says Stanley Erck, Novavax’s CEO in a company statement, “making it more important than ever that industry, government, and funding entities join forces to defeat the novel coronavirus together.”

BARDA says the doses produced for vaccination in this deal would be available to U.S. citizens at no cost, with insurers picking up the costs of administration by health care providers. As reported by Science & Enterprise in May, Novavax received a $384 million grant from Coalition for Epidemic Preparedness Innovations, or CEPI, to support early development of NVX-CoV2373, which follows World Health Organization’s guidelines for equitable global production and distribution of Covid-19 therapeutics and vaccines.

Regeneron double-antibody treatment

In a separate agreement, Regeneron is receiving $450 million from BARDA for manufacturing the company’s Covid-19 treatment code-named REGN-COV2, a dual-antibody formulation. Regeneron uses a combination of two antibodies for neutralizing the SARS-CoV-2 virus, each targeting a separate region of the characteristic protein found on the surface of the coronavirus spike, which penetrates and binds to receptor proteins in cells, beginning the infection process. Regeneron says the two antibodies in REGN-COV2 work in tandem, one antibody to start neutralizing the spike protein, with the second antibody blocking mutated forms of the virus that can form and escape after the initial attack.

Regeneron is testing REGN-COV2 in adaptive, multi-stage clinical studies enrolling patients with Covid-19 infections, both in and out of the hospital. In the trials’ early stages, the study teams are looking for signs of adverse effects from REGN-COV2 as well as indicators that it generates an immune response. The second stages will test REGN-COV2 for immune response and clinical benefits among infected Covid-19 patients.

As reported yesterday in Science & Enterprise, the company says results show, and an independent monitoring committee concurs, REGN-COV2 is safe to continue to the trial’s later stages, although detailed findings were not disclosed. Also reported yesterday, the early-stage safety results, says Regeneron, make possible a separate trial testing REGN-COV2 to protect uninfected people against Covid-19 infections. The new trial is enrolling some 2,000 participants at 100 sites in the U.S.

The BARDA agreement calls for Regeneron to produce between 70,000 and 300,000 treatment doses or 420,000 to 1.3 million prevention doses of REGN-COV2. The number and type of doses will be determined in part by results of the ongoing clinical trials. The company says it began gearing up on its own for large-scale production of REGN-COV2 in anticipation of favorable trial outcomes and emergency use authorization from Food and Drug Administration.

“We made the decision early on to begin large-scale manufacturing at our own risk,” says Regeneron president Leonard Schleifer in a company statement, “in order to ensure that product would be available immediately if our clinical trials prove successful and an emergency use authorization is granted.”

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