Novavax, Regeneron Get $2 Billion US Funds To Ramp Up Production Of Possible Coronavirus Vaccine, Treatment

Federal health officials announced agreements with two companies to produce a coronavirus vaccine and treatment, giving the U.S. government ownership of the supply. The agreements involve Novavax Inc. (NVAX) of Gaithersburg, Maryland, and Regeneron Inc. (REGN) of Tarrytown, New York.

The news sent Novavax shares soaring more than 26% in morning trading to $100.63 a share. Regeneron shares were up more than 3.5% at $649.39 a share.

Novavax, which has yet to bring a product to market, said it could have 100 million doses of its NVX CoV2373 vaccine available by the end of the year following the completion of clinical trials and Food and Drug Administration approval. Clinical trials currently are underway for Regeneron’s antiviral antibody treatment REGN-COV2, and 70,000 to 300,000 doses of the treatment could be available as early the fall.

The number of confirmed U.S. coronavirus cases was approaching 3 million Tuesday with more than 130,400 deaths. Nearly 25,000 victims were hospitalized as the pandemic surged across the Sunbelt.

Administration officials said last week the government planned to ramp up production of possible treatments and vaccines ahead of FDA approval and to use the military to help distribute them to speed efforts to contain the pandemic.

The Biomedical Advanced Research and Development Authority, the Defense Department Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense and Army Contracting Command provided $1.6 billion to Novavax and $450 million to Regeneron. The administration earlier provided $70 million to Novavax for 10 million doses of the vaccine for a phase 2/3 clinical trial.

“Operation Warp Speed is creating a portfolio of vaccines to increase the odds that we will have at least one safe, effective vaccine as soon as the end of this year,” Health and Human Services Secretary Alex Azar said.

“This agreement with Regeneron is the first of a number of Operation Warp Speed awards to support potential therapeutics all the way through to manufacturing, allowing faster distribution if trials are successful,” he added.

The Novavax vaccine, one of 21 currently in clinical trials and among more than 150 under development, uses nanoparticle technology and the company’s Matrix-M adjuvant to boost the immune response. It also incorporates a prefusion protein antigen to stimulate the immune response.

Dr. Anthony Fauci, the nation’s leading infectious disease expert, said Monday any vaccine developed this year is likely to have only limited effect.

REGN-COV2, developed with VelociSite technologies, combines two monoclonal antibodies that bind to the coronavirus’ spike protein – the portion of the virus used to invade cells and hijack the replication system. The cocktail originally was developed to treat Ebola.