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Novavax's (NVAX) COVID Jab Gets Full Approval in Europe
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Novavax (NVAX - Free Report) announced that the European Commission had granted full marketing authorization for its protein-based COVID-19 vaccine, Nuvaxovid (NVX-CoV2373), in the European Union (EU). The vaccine is approved as a primary series for individuals aged 12 and older and as a booster for those aged 18 and above.
The European Medicines Agency's Committee for Medicinal Products for Human Use had previously provided a positive opinion on the vaccine, paving the way for its full authorization.
Nuvaxovid initially obtained conditional marketing approval in the EU as a booster dose for adults aged 18 years and above in September 2022. Presently, the vaccine is approved for use in more than 40 global markets.
The approval 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 primary series and booster dose.
This year so far, shares of Novavax have plunged 31.4% against the industry’s 9.8% decline.
Image Source: Zacks Investment Research
The full approval will provide an approval pathway for an updated vaccine for the upcoming 2023 fall vaccination season.
We note that Nuvaxovid has not yet received approval from the FDA in the United States. NVAX is preparing to seek full approval in the United States and other markets. 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.
Apart from Novavax, other COVID vaccine makers like Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) and Moderna (MRNA - Free Report) are currently updating their vaccines to target the XBB lineages. During the FDA committee meeting last month, Pfizer/BioNTech, Moderna and Novavax presented their pre-clinical findings supporting the use of their vaccines, which target the XBB.1.5 variant. The pre-clinical data from these manufacturers indicate that a monovalent vaccine is more effective against a bivalent vaccine.
Last month, Pfizer and BioNTech submitted filings with both the European Medicines Agency and FDA seeking approval for their Omicron XBB.1.5-adapted monovalent COVID-19 vaccine. If approved, the companies intend to launch their vaccine for the 2023-2024 fall and winter seasons. Pfizer/BioNTech expect to make their updated vaccine ready for supply immediately post-regulatory approvals.
Novavax stated that it is manufacturing its protein-based monovalent XBB.1.5 COVID vaccine candidate at a commercial scale, intended to be in the market during the upcoming fall vaccination campaign. This vaccine is yet to be approved by any regulatory authority across the globe. Novavax aims to make its updated vaccine available and accessible on par with other COVID vaccines.
In April, the FDA amended the EUA granted to the mRNA-based vaccines developed by Pfizer/BioNTech and Moderna.
Following the EUA amendment, the current bivalent vaccines developed by Pfizer/BioNTech and Moderna would be used for all doses administered to individuals aged six months and older. Subsequently, the monovalent/original vaccines developed by these companies are no longer authorized for use in the United States. This was done with the intent to simplify the COVID immunization schedule for the majority of the country’s population.
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 a phase II clinical study involving older adults aged 50-80 years.
Image: Shutterstock
Novavax's (NVAX) COVID Jab Gets Full Approval in Europe
Novavax (NVAX - Free Report) announced that the European Commission had granted full marketing authorization for its protein-based COVID-19 vaccine, Nuvaxovid (NVX-CoV2373), in the European Union (EU). The vaccine is approved as a primary series for individuals aged 12 and older and as a booster for those aged 18 and above.
The European Medicines Agency's Committee for Medicinal Products for Human Use had previously provided a positive opinion on the vaccine, paving the way for its full authorization.
Nuvaxovid initially obtained conditional marketing approval in the EU as a booster dose for adults aged 18 years and above in September 2022. Presently, the vaccine is approved for use in more than 40 global markets.
The approval 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 primary series and booster dose.
This year so far, shares of Novavax have plunged 31.4% against the industry’s 9.8% decline.
Image Source: Zacks Investment Research
The full approval will provide an approval pathway for an updated vaccine for the upcoming 2023 fall vaccination season.
We note that Nuvaxovid has not yet received approval from the FDA in the United States. NVAX is preparing to seek full approval in the United States and other markets. 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.
Apart from Novavax, other COVID vaccine makers like Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) and Moderna (MRNA - Free Report) are currently updating their vaccines to target the XBB lineages. During the FDA committee meeting last month, Pfizer/BioNTech, Moderna and Novavax presented their pre-clinical findings supporting the use of their vaccines, which target the XBB.1.5 variant. The pre-clinical data from these manufacturers indicate that a monovalent vaccine is more effective against a bivalent vaccine.
Last month, Pfizer and BioNTech submitted filings with both the European Medicines Agency and FDA seeking approval for their Omicron XBB.1.5-adapted monovalent COVID-19 vaccine. If approved, the companies intend to launch their vaccine for the 2023-2024 fall and winter seasons. Pfizer/BioNTech expect to make their updated vaccine ready for supply immediately post-regulatory approvals.
Novavax stated that it is manufacturing its protein-based monovalent XBB.1.5 COVID vaccine candidate at a commercial scale, intended to be in the market during the upcoming fall vaccination campaign. This vaccine is yet to be approved by any regulatory authority across the globe. Novavax aims to make its updated vaccine available and accessible on par with other COVID vaccines.
In April, the FDA amended the EUA granted to the mRNA-based vaccines developed by Pfizer/BioNTech and Moderna.
Following the EUA amendment, the current bivalent vaccines developed by Pfizer/BioNTech and Moderna would be used for all doses administered to individuals aged six months and older. Subsequently, the monovalent/original vaccines developed by these companies are no longer authorized for use in the United States. This was done with the intent to simplify the COVID immunization schedule for the majority of the country’s population.
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 a phase II clinical study involving older adults aged 50-80 years.
Novavax, Inc. Price and Consensus
Novavax, Inc. price-consensus-chart | Novavax, Inc. Quote
Zacks Rank
Novavax currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.