Novavax Initiates Development of Vaccine for Wuhan Coronavirus

Novavax, a clinical-stage vaccine company headquartered in Gaithersburg, Maryland, saw its shares explode 60% in premarket trading on Tuesday.

The big jump came after the company announced that it has initiated development of a vaccine candidate for the Wuhan-version of the coronavirus that has spread from China to other Asian nations.

It was on Tuesday that it was reveale that the virus had infected at least one person in the United States.

“Using Novavax’ recombinant nanoparticle vaccine technology, the company expects to develop a vaccine candidate from the genetic sequence of the Wuhan coronavirus,” the company said in a statement.

Novavax would also utilize its proprietary Matrix-M adjuvant to potentially provide additional immune response.

It was last week that Novavax announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for NanoFlu™, its recombinant quadrivalent seasonal influenza vaccine candidate, adjuvanted with Matrix-M™, in adults 65 years of age and older.

“The FDA’s decision to grant Fast Track Designation for NanoFlu reflects the urgent unmet medical need for a more effective vaccine against influenza, particularly in the older adult population which often experiences serious and sometimes life-threatening complications, of the disease” said Stanley C. Erck, President and Chief Executive Officer of Novavax.

He added, “We believe that NanoFlu will offer an innovative improvement compared to traditional egg-based vaccines, which frequently result in mismatch and poor effectiveness. We look forward to working closely with the FDA through the expedited review process, accelerating the access to this vaccine for the most vulnerable populations.”

According to the company’s press release, the ongoing Phase 3 clinical trial is intended to evaluate the immunogenicity and safety of NanoFlu compared to the quadrivalent formulation of Fluzone.

The trial’s primary objectives are to demonstrate non-inferior immunogenicity as measured by hemagglutination inhibition (HAI) titers of vaccine homologous influenza strains compared to Fluzone, and to describe its safety profile. Top-line clinical data from the trial is expected by the end of the first quarter of 2020 and could support a U.S. biologics license application (BLA) and future licensure of NanoFlu using the FDA’s accelerated approval pathway.

Disclaimer: We have no position in Novavax, Inc. (NASDAQ: NVAX) and have not been compensated for this article.