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EMA Panel Endorses Novavax's (NVAX) COVID Jab for Full Approval

Novavax NVAX announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for its protein-based COVID-19 vaccine, Nuvaxovid (NVX-CoV2373).

This paves the way for full Marketing Authorization (MA) of the vaccine in the European Union (EU) as a primary series for individuals aged 12 and older and as a booster for those aged 18 and above.

The conditional marketing authorization in the EU for Nuvaxovid as a booster dose in adults aged 18 years and older was received in September 2022.

Currently, the vaccine is authorized for use in more than 40 markets worldwide, including the EU, where it has conditional authorization as a primary series in adults and adolescents, and as a booster in adults.

The European Commission will review the recommendation and is expected to make a final decision regarding the MA. If approved, it will provide an approval pathway for an updated vaccine for the upcoming 2023 fall vaccination season.

The CHMP recommendation is based on data from the phase III PREVENT-19 study, phase II study, and real-world evidence which have exhibited the efficacy and safety of Nuvaxovid as both a primary series and booster dose.

In the year so far, shares of Novavax have plunged 29.9% compared with the industry’s 9.2% decline.

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Zacks Investment Research

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The company markets different versions of its protein-based COVID-19 vaccine — one under the trade name Covovax (in partnership with the Serum Institute of India) and another under Nuvaxovid.

We note that Nuvaxovid has not yet received approval from the Food and Drug Administration (FDA) in the United States. In July 2022, NVAX secured emergency use authorization (EUA) from the agency for the administration of its COVID vaccine in adults.

Additionally, the vaccine is authorized as a booster dose for individuals aged 18 and older. In the United States, it is marketed as Novavax COVID-19 Vaccine, Adjuvanted.

There are other mRNA-based COVID-19 vaccines in the market that are developed by Pfizer PFE/BioNTech BNTX and Moderna MRNA. These companies did not have a strong product launch but established a strong hold on the market.

By the time Novavax was granted authorization for its vaccine, most of the population had already completed primary vaccination using Pfizer/BioNTech and Moderna’s approved mRNA-based vaccines. The mRNA-based jabs were also the first ones authorized by the FDA in 2020.

The vaccines developed by Moderna and Pfizer/BioNTech are the only ones that have received full approval for use in adults in the United States. While Moderna’s vaccine is approved for adults aged 18 years and older, the Pfizer/BioNTech vaccine is permitted for individuals aged 12 years and above.

Both these vaccines are also authorized for administration in individuals aged six months and over in the United States. Novavax’s vaccine is currently authorized as a primary regimen in adults and adolescents aged 12 years and older.

Moderna and Pfizer/BioNTech have also secured EUA from the FDA for using their respective Omicron BA.4/BA.5-adapted bivalent vaccines as a single booster dose. The bivalent vaccines of these companies are authorized for use in individuals aged six months and above.

Novavax is also making significant advancements in the development of its alternative vaccine candidates, including standalone influenza vaccines, COVID-19-influenza combination vaccines and high-dose COVID jabs.

These candidates are presently being evaluated in phase II clinical study involving older adults in the age group of 50-80 years.

The company has initiated a cost-reduction plan in May 2023 to control its cash burn, extending the existing cash runway to support its operations beyond February 2024. Per this plan, NVAX aims to reduce its existing workforce by 25%.

Novavax, Inc. Price and Consensus

Novavax, Inc. Price and Consensus
Novavax, Inc. Price and Consensus

Novavax, Inc. price-consensus-chart | Novavax, Inc. Quote

Zacks Rank and Stocks to Consider

Currently, Novavax carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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