Novavax
NVAX
recently announced that the European Commission (“EC”) expanded its conditional marketing authorization (CMA) for Nuvaxovid (NVX-CoV2373), its COVID-19 vaccine, to allow its use in adolescents aged 12 through 17 years in Europe.
Nuvaxovid received its CMA approval from EC in December 2021 for use in adults 18 years and older.
The expanded CMA follows the positive recommendation of the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (“CHMP”) for the use of Nuvaxovid in adolescents between 12 and 17 years announced in June.
EU’s expanded CMA approval was based on data from the ongoing pediatric expansion of the phase III PREVENT study, which tested Nuvaxovid’s efficacy in 2,247 adolescents across 73 sites in the United States.
The pediatric expansion study achieved its primary effectiveness endpoint. In February, management announced that the study
achieved
its primary effectiveness endpoint of NVX-CoV2373 generating neutralizing antibodies in adolescents, similar to the antibody responses in young adult participants (aged between 18 and 26 years) who were administered the vaccine in the phase III PREVENT study. The antibody responses were 1.5-fold higher in adolescents than young adults.
In the study, based on the data accrued from May 24 through Sep 27, 2021, Nuvaxovid demonstrated almost 80% efficacy against the Delta variant, which was a predominant strain at that time in the States.
With the CMA approval, Nuvaxovid becomes the first protein-based COVID vaccine to be authorized for the 12-17 years age bracket in Europe.
Shares of Novavax have plunged 55% in the trailing 12 months compared with the
industry
’s 22.1% decline.
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Moreover, earlier this year, Novavax received emergency use authorization (EUA) for Nuvaxovid, for the adolescent population, in India.
Apart from India, NVX-CoV2373 is also authorized for emergency use in adults in other highly populated markets like Australia, Canada, New Zealand, Europe and Indonesia. In April 2022, NVAX received the first approval for the use of a booster dose of NVX-CoV2373 in adults in Japan.
However, the vaccine is yet to be authorized in the United States. Novavax EUA filing with the FDA, seeking authorization for the use of Nuvaxovid in adults, is currently under review. Novavax has also submitted regulatory filings seeking approval for NVX-CoV2373 in South Africa.
Even though NVAX’s protein-based COVID vaccine has shown potential and has been gaining authorizations across the globe, it still faces stiff competition from the likes of large-cap pharma giants such as
Moderna
MRNA
and
Pfizer
PFE
/
BioNTech
BNTX
Pfizer/BioNTech and Moderna’s mRNA-based vaccines have already received full approval for use in adults in the United States.
Moreover, Moderna and Pfizer/BioNTech’s COVID vaccines have been authorized for use in children aged 6 months to 11 years old in the United States and Europe. The booster doses of these two vaccines are also authorized for use in adults aged 18 years and above in the EU and the United States.
Zacks Rank
Novavax currently carries a Zacks Rank #3 (Hold).
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the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here
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