Gaithersburg-based Novavax (NASDAQ: NVAX) shares are climbing higher after weeks of trending lower. The stock is recovering market value in the billions of dollars lost in part due to negative reporting from media outlets such as Politico, that put Novavax’s COVID-19 manufacturing capabilities into question.
The day-time high for the stock was $220.50 a share, a surge of more than 12 percent. The DOW has dropped below 350 points for the day with the NASDAQ up close to 35 points.
The biotech is inching closer to approval for its COVID-19 drug with today’s announcement that the World Health Organization (WHO) Granted Emergency Use Listing for Novavax’s NVX-CoV2373 COVID-19 Vaccine.
"Today's decision from the World Health Organization is vital to ensuring global access to a protein-based COVID-19 vaccine for hundreds of millions of people around the world," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "We thank the World Health Organization for its thorough assessment. We believe this vaccine will help overcome barriers to vaccine access in many regions of the world by leveraging the traditional refrigeration used in existing vaccine supply channels, while also offering an option based on a familiar and well-understood technology."
Novavax’s global vaccine would be distributed under the name Covovax and be manufactured by its partner the Serum Institute of India under a license agreement. Part of the COVAX facility portfolio, the plan is to vaccinate people in lower-income countries.
“Even with new variants emerging, vaccines remain one of the most effective tools to protect people against serious illness and death from SARS-COV-2,” said Dr Mariângela Simão, WHO Assistant-Director General for Access to Medicines and Health Products. “This listing aims to increase access particularly in lower-income countries, 41 of which have still not been able to vaccinate 10% of their populations, while 98 countries have not reached 40%.”
Covovax is a subunit of the Novavax COVID-19 vaccine and the Coalition for Epidemic Preparedness Innovations (CEPI). While it requires two doses, it has an advantage over existing approved vaccines such as stability at refrigerated temperatures and efficacy over 90 percent.
It also differs from competing vaccines using a novel Matrix-M platform to produce an engineered baculovirus containing a gene for a modified COVID-19 spike protein. It follows a path of more traditional vaccine methods versus the mRNA methods of Moderna and Pfizer.
The Nuvaxovid vaccine is currently under review by the European Medicines Agency (EMA) and could receive approval next week, according to some reports. Nuvaxovid is the original product that Covavax is based on and would be available to countries under the EMA and the U.K. which has its own health agency to approve drugs. WHO is waiting for recommendation from EMA before it completes its own assessment of Novavax’s Nuvaxovid vaccine