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Novavax (NVAX) Gets EU Nod for COVID-19 Booster Jab in Adults
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Novavax (NVAX - Free Report) announced that the European Commission (EC) expanded its conditional marketing authorization (CMA) for Nuvaxovid (NVX-CoV2373), its protein-based COVID-19 vaccine, to allow its use as a booster dose in adults aged 18 years and older in the European Union (EU).
Following the EC decision, Nuvaxovid can now be administered as a booster dose, irrespective of whether or not the primary vaccine regimen series was completed with Nuvaxovid.
This label expansion will enable Novavax to target a larger segment of the adult population who have already completed a primary vaccination series but are yet to receive a booster dose.
Though Novavax’s COVID-19 vaccine has been authorized in the EU as a primary two-dose regimen in individuals aged 12 years and older, a majority of the population has been immunized with an authorized primary regimen of a vaccine developed by Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) , Moderna (MRNA - Free Report) and AstraZeneca. Owing to label expansion to Nuvaxovid, Novavax can now cater to a broader population regardless of whether they have completed a primary vaccine regimen using Nuvaxovid or any other authorized vaccine.
The authorization follows a positive review by the Committee for Medicinal Products for Human Use (CHMP), which recommended the vaccine’s use as a booster earlierthis month. The decision by the EC and CHMP was based on multiple mid-stage studies conducted by Novavax separately in Australia, South Africa and the U.K., evaluating a booster dose of NVX-CoV2373.
Data from these studies showed that a third dose of the vaccine generated increased immune responses compared with the data observed in late-stage studies evaluating Nuvaxovid. The vaccine also induced a robust antibody response when used as a heterologous booster dose.
Shares of Novavax have plunged 76.9% so far this year compared with the industry’s 21.2% decline.
Image Source: Zacks Investment Research
Last month, NVAX filed a regulatory application with the FDA, seeking authorization for using NVX-CoV2373 as a homologous and heterologous booster dose in adults. The vaccine is currently authorized by the FDA for use as a primary two-dose regimen in individuals aged 12 years and older.
A booster dose of NVX-CoV2373 is currently authorized for use in adults in Australia, Japan and New Zealand.
Novavax is currently marketing two versions of NVX-CoV2373 — one in partnership with the Serum Institute of India under the trade name Covovax, and the other, produced by itself and marketed under the trade name Nuvaxovid.
Novavax’s COVID vaccine faces stiff competition from the mRNA-based COVID-19 vaccines developed and marketed by Pfizer/BioNTech and Moderna.
Novavax is currently lagging behind Moderna and Pfizer/BioNTech, whose vaccines 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 approved for use in individuals aged 12 years and older. Both these vaccines are also authorized for use in individuals aged six months and above in the United States. A third and fourth booster dose of Moderna and Pfizer/BioNTech vaccines have been authorized for use in certain age groups by the FDA.
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. While Moderna’s Omicron booster is approved for individuals 18 years of age and older, Pfizer/Moderna’s version is approved for people 12 and older. These vaccines have been specifically developed to cater to the U.S. market, where the Omicron subvariants BA.4 and BA.5 are the most prevalent variants.
Novavax is also advancing the clinical development of its Omicron-based COVID vaccine. While the top-line data is expected in third-quarter 2022, management expects to initiate a regulatory filing with the FDA for this Omicron-specific vaccine candidate by 2022-end.
Image: Shutterstock
Novavax (NVAX) Gets EU Nod for COVID-19 Booster Jab in Adults
Novavax (NVAX - Free Report) announced that the European Commission (EC) expanded its conditional marketing authorization (CMA) for Nuvaxovid (NVX-CoV2373), its protein-based COVID-19 vaccine, to allow its use as a booster dose in adults aged 18 years and older in the European Union (EU).
Following the EC decision, Nuvaxovid can now be administered as a booster dose, irrespective of whether or not the primary vaccine regimen series was completed with Nuvaxovid.
This label expansion will enable Novavax to target a larger segment of the adult population who have already completed a primary vaccination series but are yet to receive a booster dose.
Though Novavax’s COVID-19 vaccine has been authorized in the EU as a primary two-dose regimen in individuals aged 12 years and older, a majority of the population has been immunized with an authorized primary regimen of a vaccine developed by Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) , Moderna (MRNA - Free Report) and AstraZeneca. Owing to label expansion to Nuvaxovid, Novavax can now cater to a broader population regardless of whether they have completed a primary vaccine regimen using Nuvaxovid or any other authorized vaccine.
The authorization follows a positive review by the Committee for Medicinal Products for Human Use (CHMP), which recommended the vaccine’s use as a booster earlierthis month. The decision by the EC and CHMP was based on multiple mid-stage studies conducted by Novavax separately in Australia, South Africa and the U.K., evaluating a booster dose of NVX-CoV2373.
Data from these studies showed that a third dose of the vaccine generated increased immune responses compared with the data observed in late-stage studies evaluating Nuvaxovid. The vaccine also induced a robust antibody response when used as a heterologous booster dose.
Shares of Novavax have plunged 76.9% so far this year compared with the industry’s 21.2% decline.
Image Source: Zacks Investment Research
Last month, NVAX filed a regulatory application with the FDA, seeking authorization for using NVX-CoV2373 as a homologous and heterologous booster dose in adults. The vaccine is currently authorized by the FDA for use as a primary two-dose regimen in individuals aged 12 years and older.
A booster dose of NVX-CoV2373 is currently authorized for use in adults in Australia, Japan and New Zealand.
Novavax is currently marketing two versions of NVX-CoV2373 — one in partnership with the Serum Institute of India under the trade name Covovax, and the other, produced by itself and marketed under the trade name Nuvaxovid.
Novavax’s COVID vaccine faces stiff competition from the mRNA-based COVID-19 vaccines developed and marketed by Pfizer/BioNTech and Moderna.
Novavax is currently lagging behind Moderna and Pfizer/BioNTech, whose vaccines 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 approved for use in individuals aged 12 years and older. Both these vaccines are also authorized for use in individuals aged six months and above in the United States. A third and fourth booster dose of Moderna and Pfizer/BioNTech vaccines have been authorized for use in certain age groups by the FDA.
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. While Moderna’s Omicron booster is approved for individuals 18 years of age and older, Pfizer/Moderna’s version is approved for people 12 and older. These vaccines have been specifically developed to cater to the U.S. market, where the Omicron subvariants BA.4 and BA.5 are the most prevalent variants.
Novavax is also advancing the clinical development of its Omicron-based COVID vaccine. While the top-line data is expected in third-quarter 2022, management expects to initiate a regulatory filing with the FDA for this Omicron-specific vaccine candidate by 2022-end.
Novavax, Inc. Price
Novavax, Inc. price | 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.