Covid-19 is not going anywhere just yet, which of course, in a perverse way, is good news for vaccine maker Novavax (NVAX).
On Monday, the company announced that the European Medicines Agency (EMA) had granted conditional marketing authorization for its Covid-19 vaccine – NVX-CoV2373 (branded Nuvaxovid in the EU) – for individuals 18 years of age and older, which is essentially a recommendation for approval.
H.C. Wainwright’s Vernon Bernardino expects the European Commission (EC) to give the go ahead in early January.
“We see this as a great catalyst for Novavax stock, and point to the Novavax advance purchase agreement (APA) entered into in August 2021 with the EC for up to 200M ‘2373 doses, as support for positive future prospects for Nuvaxovid,” the 5-star analyst opined. (To watch Bernardino’s track record, click here)
The latest development follows other recent encouraging news. Last week, the WHO granted Emergency Use Listing (EUL) for NVX-CoV2373 (under the brand name of COVAVAX), which is manufactured and marketed by the Serum Institute of India (SII).
Marking it as the 9th EUL COVID vaccine, B. Riley’s Mayank Mamtani says the EUL approval is a “bigger deal than you think.”
“COVAVAX is the first EUL granted by WHO for a protein-based COVID-19 vaccine which is manufactured and marketed by SII,” the analyst explained. “The convenience of standard storage temperatures, and potential in mix and match and booster regimens, marks a new tool that provides low-income countries to fight against coming Omicron waves.”
For the countries which belong to the COVID-19 Vaccines Global Access (COVAX) Facility, Emergency Use Listing is a prerequisite and enables COVAVAX “to be eligible to fulfill the facility commitment to low-income countries, many of which remain largely unvaccinated.” In February, Novavax and SII announced that they intend to provide 1.1 billion doses of the vaccine to COVAX.
Wait, there’s more. Last Thursday, Novavax disclosed that that its collaborator, Takeda Pharmaceutical, has filed for approval of NVX-CoV2373 in Japan, while earlier in the week, Novavax filed for Emergency Use Authorization (EUA) in the United Arab Emirates. Finally, the company said its request for EUA approval in the U.S. should also be filed shortly, possibly even this week.
Overall, NVAX boasts a Strong Buy analyst consensus rating, based on 3 Buy ratings and 1 Hold. The stock has an average price target of $270, which suggests a 12-month upside of ~48% from the current trading price of $183.43. (See Novavax stock forecast on TipRanks)
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