Novavax (NVAX) Lags in COVID Vaccine Race: Will It Gather Pace?
Novavax Inc. NVAX is a biotechnology company engaged in developing innovative vaccines to prevent serious infectious diseases. It is also developing its proprietary adjuvant, Matrix-M, to increase immune responses.
The company’s shares showed a strong uptrend in 2020 and have gained nearly 27-fold in a year since Dec 31, 2019. The uptrend was mainly driven by the company’s progress with its promising nanoparticle-based COVID-19 vaccine candidate, NVX-CoV2373. Although the company has made progress with the vaccine so far in 2021 and witnessed upward share price movement, the strong momentum of 2020 seems to be missing, primarily due to the failure to gain any authorization for the vaccine so far.
Based on data from a late-stage study announced in June 2021, the company’s COVID-19 vaccine candidate demonstrated an overall vaccine efficacy of 90.4% and achieved 100% protection against moderate and severe coronavirus disease. The COVID-19 vaccine candidate was found to be effective against strains of the coronavirus first found in the United Kingdom, the United States, Brazil, South Africa and India.
NVX-CoV2373 is also being evaluated in adolescents aged between 12 years and less than 17 years.
The company’s COVID-19 vaccine is lagging the race as billions of people have already received the vaccine this year. We note that Pfizer PFE/ BioNTech’s Comirnaty and Moderna MRNA were granted emergency use authorization (“EUA”) by the FDA in December last year. Comirnaty also received “full” FDA approval as a COVID-19 vaccine for adults last month. J&J JNJ received EUA in the United States for its single-shot COVID-19 vaccine in February this year. Although AstraZeneca’s COVID-19 vaccine is yet be authorized in the United States, it is available in multiple other countries.
The longer the delay in getting an authorization or approval for NVX-CoV2373, the slimmer the chances of gaining a significant chunk of the market for COVID-19 vaccines. Moreover, competition will rise with an increase in available vaccines going forward as other players with a COVID-19 vaccine candidate are also vying for an authorization or approval. Moreover, the development of oral antiviral therapies for COVID-19 also threatens the opportunity for vaccines.
We note that the mRNA-based vaccines from Pfizer and Moderna are leading the COVID-19 vaccine space and are expected to generate aggregate revenues of more than $50 billion in 2021. However, there have been reports of safety issues with these two vaccines including heart inflammation. Adenovirus-based vaccines were also found to have rare safety issues. These safety concerns with available COVID-19 vaccine can pave the way for acceptance of a vaccine developed using a different technology. Novavax’s nanotechnology-based vaccine can become a possible alternative going forward. The vaccine candidate is also one of the leaders among the COVID-19 vaccines still under development. The company has already filed for Emergency Use listing with the World Health Organization last month and plans to submit an EUA request with the FDA by the year-end. The company is on track to achieve capacity of 150 million doses per month by the end of 2021. It also has signed advance purchase agreements for more than one billion doses with different countries and organizations. A smooth delivery of the COVID-19 vaccine will boost the company’s prospects in 2022.
Apart from the COVID-19 vaccine, the company is also developing a nanoparticle-based seasonal influenza vaccine candidate, NanoFlu, for senior patients. The company has successfully completed a late-stage study evaluating the candidate and plans to file a regulatory application seeking its approval soon. Although the flu vaccine in the United States is majorly government-controlled, the flu vaccine market represents a blockbuster opportunity. The company is developing a nanoparticle-based vaccine for malaria in a late-stage study.
Meanwhile, the company is also evaluating a combined COVID/flu vaccine. The company has separately completed late-stage studies on either vaccine candidates and both of them have shown promising results individually. We expect the combination vaccine tol also demonstrate similar results. A successful development of the combined COVID/flu vaccine may put the company ahead of its competitors.
Although the strong momentum in Novavax’s share price has slowed down in 2021, the next year holds promise for the company. A potential authorization or approval to its COVID-19 vaccine and flu vaccine will likely help the company’s stock to turn around. However, the COVID-19 space seems to ever changing. Lower effectiveness of the company’s vaccine due to a new variant or the anticipated rise in competition from new vaccines or therapies may push the company off the track.
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