Shares of Novavax, Inc. (NASDAQ: NVAX), which is facing an inordinate delay in getting authorization for its COVID-19 vaccine, are moving sharply lower Wednesday.
Novavax Reportedly Facing Concerning Manufacturing Issues: Amid the delay in authorization, reports suggest the company is facing issues with the purity of the vaccine candidate.
The method Novavax uses to test the purity of the vaccine has fallen short of the standards of the Food and Drug Administration, Politico reported citing people familiar with the matter. Reportedly, the company hasn’t been able to prove that it can produce a vaccine that is “consistently up to snuff.”
FDA guidance issued in June 2020 mandates each batch of vaccine should attain at least 90% purity, while Novavax has been able to show purity levels of only around 70%, the report said.
Low purity levels would mean there are contaminants or unnecessary substances in the final product, resulting in reduced efficacy for the final product.
Novavax may not possess the wherewithal to produce high-quality vaccines consistently. The company could sort out the issues and get full licensure only by the end of 2022, the report said.
Related Link: Novavax Looks Like It’s Bouncing Off Support In A Pattern
Heterologous Regimen Study Shows More Work Needed For Interpreting Antibody Data: Novavax presented at the World Vaccine Congress Barcelona, the topline immunogenicity and reactogenicity data from a Phase 2 COVID-19 vaccine schedule combinations study conducted by the University of Oxford. Novavax’s recombinant nanoparticle protein-based COVID-19 vaccine candidate NVX-CoV2373 was also one of the four vaccines studied.
The study showed that NVX-CoV2373 was well tolerated and generated a robust immune response when given as the second dose in a mixed or heterologous regimen after either AstraZeneca plc. (NASDAQ: AZN) or Pfizer, Inc. (NYSE: PFE)/BioNTech SE (NASDAQ: BNTX) vaccine as the first dose.
The company, however, said in the absence of correlates of protection and standardized assays, more work is needed to interpret the clinical significance of the Immunoglobulin G data.
Insider Selling Continues: In a filing with the SEC, the company disclosed that Gregory Glenn, its President, R&D, sold 1,183 shares in the company at $170 per share. The executive acquired the shares sold on exercising stock options.
Several of the company’s executives have cashed in, taking advantage of the vaccine-induced rally in the stock.
Price Action: NVAX shares plunged 18.20% to $131.40 in premarket trading on the last check Wednesday.
Photo by torstensimon from Pixabay
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