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Int’l Group Backs Novavax Covid-19 Vaccine

SARS-Cov-2 virus

Scanning electron microscope image of SARS-Cov-2 virus, responsible for Covid-19 infections (NIH.gov)

12 May 2020. A global consortium is funding a biotechnology company’s clinical trials and manufacturing plans for a vaccine protecting against Covid-19 viruses. The Coalition for Epidemic Preparedness Innovations, based in Oslo, Norway, yesterday awarded $384 million to Novavax Inc. in Gaithersburg, Maryland to support development and eventual production and distribution of its vaccine following the World Health Organization’s guidelines for equitable access.

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.

As reported by Science & Enterprise last month, Novavax’s vaccine protecting against the SARS-CoV-2 virus responsible for Covid-19, is set to begin an early-stage clinical trial this month in Australia. The company says the vaccine, code-named NVX-CoV2373, has shown in animal tests to create antibodies that prevent binding of the virus’s characteristic spike protein with human receptors, thus preventing infections. According to the company, NVX-CoV2373 also generates antibodies that neutralize the SARS-CoV-2 virus with one dose, and with two doses produces these antibodies with a titer volume — a measure of antibody concentration — likely to be effective in humans.

In March, Novavax received $4 million from CEPI, to develop its SARS-CoV-2 vaccine. The new CEPI funding of $384 million supports more preclinical testing of the vaccine as well as mid-stage trials in multiple countries. The funds also cover transfer of the vaccine to manufacturing sites for large-scale production in different regions, should the trials show the vaccine is successful, aiming for 100 million doses by the end of the year. In April, Novavax arranged for an American company, Emergent BioSolutions, also in Gaithersburg, to produce NVX-CoV2373 vaccines for its clinical trials.

In addition, the funding supports production of Novavax’s vaccine adjuvant called Matrix-M to boost the immune response, allowing for lower doses of the primary vaccine. For the Covid-19 vaccine, Matrix-M will be produced at a plant in Uppsala, Sweden and one other site to be named later.

“In response to this global pandemic we’re having to be innovative in the way we approach vaccine development and manufacturing,” says CEPI CEO Richard Hatchett in a statement. “We need to make progress on manufacturing in parallel with the clinical development of the vaccine, so that if the vaccine is proven to be safe and effective, we can make doses available to those who need them without delay.”

CEPI and Novavax also say the vaccine, once produced, will be distributed worldwide according to guidelines in WHO’s Access to Covid-19 Tools or ACT, Accelerator. The ACT Accelerator, begun on 24 April and supported by industry associations and non-governmental organizations including CEPI, calls for international cooperation to insure equitable production and distribution of Covid-19 therapeutics and vaccines.

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