Novavax (NASDAQ:NVAX), Inc. NVAX announced that the World Health Organization (WHO) has granted emergency use listing (EUL) of its COVID-19 vaccine, NVX-CoV2373. Following the listing, NVX-CoV2373 is the first protein-based COVID-19 vaccine to be granted EUL by WHO.
Please note that the EUL has been granted to NVX-CoV2373 manufactured by Serum Institute of India (“SII”) under a license from Novavax. Presently, SII markets NVX-CoV2373 under the brand name Covovax in Indonesia and the Philippines.
The COVID-19 vaccines that are granted EUL by WHO meet WHO standards for quality, safety and efficacy. Furthermore, this listing also enables a company to supply its COVID-19 vaccine to nations participating in the COVAX facility. The COVAX facility aims to provide equitable access to COVID vaccines across low- and lower-middle-income countries.
Covovax is the ninth COVID vaccine to be granted EUL by WHO. Following the grant of EUL, the vaccine is now pre-qualified for supply to numerous countries participating through the COVAX facility. Novavax and SII already have an agreement to jointly supply 1.1 billion doses of NVX-CoV2373 to Gavi through the COVAX facility.
Novavax’s shares increased 11.5% on Friday, following the above news. In fact, the stock has rallied 94.9% so far this year against the industry’s 19% decline.
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The granted EUL is based on data from two pivotal phase III studies evaluating the vaccine – one study (PREVENT-19) conducted in the United States and Mexico and another in the United Kingdom. While the PREVENT-19 study achieved an overall vaccine efficacy of 90.4%, the data from the study conducted in the United Kingdom demonstrated that the vaccine achieved an overall efficacy of 89.7%.
The company’s own produced version of the vaccine, which will be marketed under the trade name Nuvaxovid, is currently under review by WHO. The review of Nuvaxovid by WHO will be completed after the European Medicines Agency (EMA) completes its own review and issues a recommendation on the vaccine.
Last month, Novavax announced that the EMA has already started assessment of the vaccine under an accelerated timeline and expects to issue an opinion on the same in a few weeks’ time.
Novavax is yet to apply in the United States for an emergency use authorization of its COVID vaccine. The company reiterated its plans to apply to the FDA for the same by 2021-end.
Novavax has submitted regulatory filings seeking approval for the NVX-CoV2373 in multiple markets, which include Australia, Canada, India, Japan, New Zealand, South Korea, UAE and the United Kingdom. The company has already entered into advance purchase agreements with many of these nations for supplying doses of its COVID vaccine. A potential approval in any of these markets will give an impetus to the top line.
Zacks Rank & Stocks to Consider
Novavax currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the overall healthcare sector include GlaxoSmithKline (NYSE:GSK) GSK, IVERIC bio (NASDAQ:ISEE) ISEE and Repligen (NASDAQ:RGEN) RGEN. While Repligen sports a Zacks Rank #1 (Strong Buy), both GlaxoSmithKline and IVERIC bio presently carry has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Repligen’s earnings per share estimates for 2021 have increased from $2.76 to $2.90 in the past 60 days. The same for 2022 has increased from $3.03 to $3.21 in the past 60 days. Shares of Repligen have risen 38.5% in the year so far.
Earnings of Repligen beat estimates in all the last four quarters, delivering a surprise of 49.2%, on average.
IVERIC bio’s loss per share estimates for 2021 have narrowed from $1.18 to $1.09 in the past 60 days. The same for 2022 has narrowed from $1.17 to $1.03 in the past 60 days. Shares of IVERIC bio have gained 121% in the year so far.
IVERIC bio’s earnings missed estimates in three of the last four quarters and surpassed expectations once, with the negative surprise being 5.6%, on average.
GlaxoSmithKline’searnings estimates per share for 2021 have increased from $2.82 to $3.05 in the past 60 days. The same for 2022 has increased from $3.08 to $3.25 in the past 60 days. Shares of Glaxo have risen 17.1% in the year so far.
Earnings of GlaxoSmithKlinebeat estimates in three of the last four quarters and missed expectations in one, with the average surprise being 15.3%.
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