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Covid-19 Vaccine in Development, Trial Planned

Coronavirus graphic

(Pete Linforth, Pixabay)

8 Apr. 2020. A biotechnology company specializing in infectious diseases is developing a vaccine to protect against Covid-19 infections, with a clinical trial to start next month. Novavax Inc. in Gaithersburg, Maryland also arranged for manufacturing of the vaccine with a nearby biopharmaceutical company.

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.

Novavax is already developing vaccines against the respiratory syncytial virus, a common infection that can lead to bronchitis or pneumonia, as well as influenza and Ebola, all in clinical trials. The influenza vaccine, designed for older individuals more susceptible to flu complications, includes the company’s adjuvant, a supplement called Matrix-M to boost the immune response, allowing for lower doses of the primary vaccine.

In March, Novavax received $4 million from Coalition for Epidemic Preparedness Innovations, or CEPI, to develop a vaccine against the SARS-CoV-2 virus. For this vaccine, now code-named NVX-CoV2373, Novavax is collaborating with virologist Matthew Frieman at University of Maryland. The company partnered with Frieman earlier, to design a vaccine against Middle East Respiratory Syndrome, or MERS, also in the coronavirus family, as reported by Science & Enterprise in April 2014.

Novavax says in tests with lab animals, NVX-CoV2373 creates antibodies that prevent binding of the virus’s characteristic spike protein with human receptors, thus preventing infections. The vaccine, according to the company, 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.

“We validated that NVX-CoV2373 generates high titer neutralizing antibodies against live SARS-CoV-2 virus,” says Frieman in a Novavax statement. “This is strong evidence that the vaccine created by Novavax has the potential to be highly immunogenic in humans which could lead to protection from Covid-19 and helping to control the spread of this disease.”

The company plans an early-stage clinical trial to test NVX-CoV2373 beginning in mid-May. Novavx expects to enroll some 130 participants testing the vaccine for signs of adverse effects and its ability to produce an immune response. With that size sample, says the company, the trial can also test for dosage level and number of vaccinations against a placebo, possibly generating equivalent evidence of a mid-stage trial. Initial results are expected in July.

In addition, Novavax plans to extend an agreement with biopharmaceutical company Emergent BioSolutions, also in Gaithersburg, to manufacture NVX-CoV2373 vaccines for its clinical trials. On 31 March, Emergent BioSolutions agreed to produce Novavax’s influenza vaccine in Emergent’s Baltimore plant. Emergent BioSolutions also received a $14.5 million award from the U.S. Biomedical Advanced Research and Development Authority to take part in development of a treatment for Covid-19 infections derived from antibodies in blood plasma in people who recovered from the disease.

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