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Novavax (NVAX) Seeks EU Nod for COVID-19 Vaccine in Kids

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Novavax (NVAX - Free Report) announced that it has filed a regulatory application in the European Union (“EU”), which seeks to expand the marketing authorization granted to Nuvaxovid, its COVID-19 vaccine, to include the adolescent population aged between 12 and 17 years.

The filing in the EU is based on data from the phase III PREVENT-19 pediatric expansion study, which evaluated NVAX’s vaccine in 2,247 adolescents. The pediatric expansion study achieved its primary effectiveness endpoint of Nuvaxovid generating neutralizing antibodies in adolescents, similar to the antibody responses in young adult patients (aged between 18 and 26 years) who were administered the vaccine in the phase III PREVENT-19 study.

Shares of Novavax have plunged 48.5% in the year-to-date period compared with the industry’s 12% decline.

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Nuvaxovid is presently authorized in the EU for use in adults aged 18 years and older. If Novavax receives authorization for use in the adolescent population, Nuvaxovid will become the first protein-based COVID vaccine for the 12-17 years age bracket in the EU.

Last month, Novavax received the first authorization to use its COVID vaccine in the adolescent population in India.

NVAX’s request for authorization is also followed by the recent reports of the rising COVID-19 infection rates in Europe resulting from the Omicron BA.2 subvariant. This has once again refueled the demand for COVID vaccines. Another wave of COVID-19 infection across the globe may lead to ramped-up COVID-19 vaccination programs in different countries.

Nuvaxovid is yet to be authorized in the United States. Novavax has already submitted a regulatory application with the FDA seeking emergency use for Nuvaxovid in adults, which is currently under review. Similar regulatory filings seeking authorizations for the company’s COVID vaccine are also under review in Japan and South Africa.

Apart from Nuvaxovid, there are currently four more vaccines that are authorized for use in the EU. These vaccines are being marketed by Moderna (MRNA - Free Report) , Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) , J&J and AstraZeneca. In fact, the authorizations for these vaccines are not just limited to Europe but also authorized for use in multiple nations.

Currently, the COVID-19 vaccines developed by Moderna and Pfizer/BioNTech dominate not only the European market but also other markets including the United States. The vaccines developed by Moderna and Pfizer/BioNTech are based on the mRNA technology and have demonstrated robust antibody levels in comparison with other vaccines like those of AstraZeneca and J&J, which are adenovirus-based vaccines.

In fact, the COVID vaccines developed by Moderna and Pfizer/BioNTech are currently the only ones that are authorized for use in children and adolescents in the EU. While Moderna’s COVID vaccine is currently authorized for use in individuals aged six years and older, Pfizer/BioNTech’s COVID vaccine is authorized for use in people aged 5 years and older. The booster doses of these two vaccines are also authorized for use in adults aged 18 years and above in the EU.

A third/booster dose of both Moderna and Pfizer’s COVID vaccines is also authorized for use in the United States. Although the booster dose of both these vaccines is authorized by the FDA for use in adults, Pfizer’s vaccine is currently the only vaccine whose booster dose is authorized for use in adolescents. Earlier this week, the FDA authorized the use of a second booster dose of Pfizer/BioNTech and Moderna’s COVID vaccines for older adults (aged 50 years and older) and some immunocompromised people.

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Novavax currently carries a Zacks Rank #4 (Sell).

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