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Novavax (NVAX) COVID Vaccine Gets EU Nod, 2nd Listing by WHO
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Novavax (NVAX - Free Report) announced that the European Commission (“EC”) has approved the conditional marketing authorization (CMA) seeking approval for its protein-based COVID vaccine, NVX-CoV2373.
Following the EC approval, NVX-CoV2373 became the first protein-based COVID-19 vaccine authorized for use in the European Union (EU). The vaccine will be marketed in the EU under the brand name Nuvaxovid.
We note that the EC approval follows the positive recommendation from the Committee for Medicinal Products for Human Use (“CHMP”) to authorize the COVID vaccine in the EU earlier on Monday.
The EC decision and positive recommendation from CHMP are based on data from two pivotal phase III studies on the vaccine — one (PREVENT-19) conducted in the United States and Mexico and another in the United Kingdom. While the PREVENT-19 study achieved an overall vaccine efficacy of 90.4%, the data from the study conducted in the United Kingdom demonstrated that the vaccine achieved an overall efficacy of 89.7%.
Nuvaxovid is the fifth COVID vaccine approved in the EU. The other vaccines approved in Europe are those of Johnson & Johnson (JNJ - Free Report) , Moderna (MRNA - Free Report) , Pfizer (PFE - Free Report) /BioNTech, and AstraZeneca.
Novavax already has an advanced purchase agreement with EC to supply up to 200 million doses of Novavax’s COVID vaccine. In fact, the member states have already ordered around 27 million doses of the vaccine for first-quarter 2022. The initial doses are expected to arrive in the EU in January.
Shares of Novavax have rallied 81.1% so far this year against the industry’s 19.8% decline.
Image Source: Zacks Investment Research
Apart from the EU, Novavax and partner Serum Institute of India (“SII”) have secured authorization for its COVID vaccine in Indonesia and the Philippines, where it will be commercialized by the name of Covavax.
In a separate press release, Novavax also announced that the World Health Organization (WHO) granted emergency use listing (EUL) to the company’s own produced version of NVX-CoV2373.
We remind investors that this is the second EUL granted to its COVID vaccine by WHO. Last week, the company announced that Covovax secured EUL from WHO. Both Nuvaxovid and Covovax are based on the same Novavax recombinant technology.
Novavax has submitted regulatory filings seeking approval for the NVX-CoV2373 in multiple markets including Australia, Canada, India, Japan, New Zealand, South Korea, UAE and the United Kingdom. The company has already entered into advance purchase agreements with many of these nations for supplying doses of its COVID vaccine. A potential approval in any of these markets will give a boost to the company’s revenues.
We note that Novavax is yet to apply in the United States for an emergency use authorization of its COVID vaccine. The company expects to submit the complete chemistry, manufacturing and controls data package to the FDA for the same by 2021-end.
Apart from Novavax, EC has entered into advanced purchase agreements (APAs) with multiple vaccine-making companies to ensure access of COVID vaccines to all the EU members states.
Pfizer has secured multiple APAs from the EC. These APAs allow the EC to purchase a total of 2.4 billion doses of Pfizer’s COVID vaccine, Cominarty. Last month, the Committee for Medicinal Products for Human Use (“CHMP”) gave a positive opinion recommending extended use of Pfizer’s Cominarty in children five to under 12 years of age in Europe.
Moderna also has entered into multiple APAs with EC. These APAs allow the EC to procure up to 460 million doses of Moderna’s COVID vaccine, mRNA-1273. Last month, Moderna announced that it had submitted a regulatory application in Europe seeking CMA for the use of mRNA-1273 in children aged 6 to 11 years.
J&J secured an APA with the EC in October 2020 for a total supply of 400 million doses of its COVID vaccine. Unlike other COVID vaccines that require administering more than one dose, J&J’s vaccine is a single-dose COVID-19 vaccine.
Last week, J&J announced that the CHMP recommended the use of the booster dose of its single-shot COVID-19 vaccine. The CHMP supported the use of J&J’s booster dose in adults, administered at least two months after the primary vaccination with J&J’s vaccine.
Image: Shutterstock
Novavax (NVAX) COVID Vaccine Gets EU Nod, 2nd Listing by WHO
Novavax (NVAX - Free Report) announced that the European Commission (“EC”) has approved the conditional marketing authorization (CMA) seeking approval for its protein-based COVID vaccine, NVX-CoV2373.
Following the EC approval, NVX-CoV2373 became the first protein-based COVID-19 vaccine authorized for use in the European Union (EU). The vaccine will be marketed in the EU under the brand name Nuvaxovid.
We note that the EC approval follows the positive recommendation from the Committee for Medicinal Products for Human Use (“CHMP”) to authorize the COVID vaccine in the EU earlier on Monday.
The EC decision and positive recommendation from CHMP are based on data from two pivotal phase III studies on the vaccine — one (PREVENT-19) conducted in the United States and Mexico and another in the United Kingdom. While the PREVENT-19 study achieved an overall vaccine efficacy of 90.4%, the data from the study conducted in the United Kingdom demonstrated that the vaccine achieved an overall efficacy of 89.7%.
Nuvaxovid is the fifth COVID vaccine approved in the EU. The other vaccines approved in Europe are those of Johnson & Johnson (JNJ - Free Report) , Moderna (MRNA - Free Report) , Pfizer (PFE - Free Report) /BioNTech, and AstraZeneca.
Novavax already has an advanced purchase agreement with EC to supply up to 200 million doses of Novavax’s COVID vaccine. In fact, the member states have already ordered around 27 million doses of the vaccine for first-quarter 2022. The initial doses are expected to arrive in the EU in January.
Shares of Novavax have rallied 81.1% so far this year against the industry’s 19.8% decline.
Apart from the EU, Novavax and partner Serum Institute of India (“SII”) have secured authorization for its COVID vaccine in Indonesia and the Philippines, where it will be commercialized by the name of Covavax.
In a separate press release, Novavax also announced that the World Health Organization (WHO) granted emergency use listing (EUL) to the company’s own produced version of NVX-CoV2373.
We remind investors that this is the second EUL granted to its COVID vaccine by WHO. Last week, the company announced that Covovax secured EUL from WHO. Both Nuvaxovid and Covovax are based on the same Novavax recombinant technology.
Novavax has submitted regulatory filings seeking approval for the NVX-CoV2373 in multiple markets including Australia, Canada, India, Japan, New Zealand, South Korea, UAE and the United Kingdom. The company has already entered into advance purchase agreements with many of these nations for supplying doses of its COVID vaccine. A potential approval in any of these markets will give a boost to the company’s revenues.
We note that Novavax is yet to apply in the United States for an emergency use authorization of its COVID vaccine. The company expects to submit the complete chemistry, manufacturing and controls data package to the FDA for the same by 2021-end.
Apart from Novavax, EC has entered into advanced purchase agreements (APAs) with multiple vaccine-making companies to ensure access of COVID vaccines to all the EU members states.
Pfizer has secured multiple APAs from the EC. These APAs allow the EC to purchase a total of 2.4 billion doses of Pfizer’s COVID vaccine, Cominarty. Last month, the Committee for Medicinal Products for Human Use (“CHMP”) gave a positive opinion recommending extended use of Pfizer’s Cominarty in children five to under 12 years of age in Europe.
Moderna also has entered into multiple APAs with EC. These APAs allow the EC to procure up to 460 million doses of Moderna’s COVID vaccine, mRNA-1273. Last month, Moderna announced that it had submitted a regulatory application in Europe seeking CMA for the use of mRNA-1273 in children aged 6 to 11 years.
J&J secured an APA with the EC in October 2020 for a total supply of 400 million doses of its COVID vaccine. Unlike other COVID vaccines that require administering more than one dose, J&J’s vaccine is a single-dose COVID-19 vaccine.
Last week, J&J announced that the CHMP recommended the use of the booster dose of its single-shot COVID-19 vaccine. The CHMP supported the use of J&J’s booster dose in adults, administered at least two months after the primary vaccination with J&J’s vaccine.
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Novavax currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.