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Novavax (NVAX) Stock Rises on Deal for COVID-19 Jab in Israel
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Shares of Novavax, Inc. (NVAX - Free Report) surged 13.7% on Jan 28 after the company announced that it has entered into an advance purchase agreement with Israel's Ministry of Health for the supply of its protein-based COVID-19 vaccine, NVX-CoV2373. Novavax’s vaccine has not yet been authorized in Israel.
Novavax’s shares were up in pre-market trading on Monday. However, the stock has plunged 69.1% in the past year compared with the industry’s decrease of 38.8%.
Image Source: Zacks Investment Research
Per the latest advance purchase agreement, Novavax will initially supply five million doses of NVX-CoV2373 while the Ministry of Health in Israel will have the option to purchase an additional five million doses. Upon regulatory approval in Israel, Novavax and the Ministry of Health will finalize the distribution plans for NVX-CoV2373.
NVX-CoV2373 has already received approval for emergency use in multiple countries outside the United States. Novavax is currently marketing two versions of NVX-CoV2373 — one marketed in partnership with the Serum Institute of India under the trade name Covovax and another version produced by Novavax that is marketed under the trade name Nuvaxovid.
While Covovax is authorized for emergency use in India, Indonesia and the Philippines, Nuvaxovid was granted conditional marketing authorization in the European Union (EU) in December 2021.
The World Health Organization has granted emergency use listing to both Covovax and Nuvaxovid. Following this, the vaccine is now pre-qualified for supply to several countries participating through the COVAX facility.
However, Novavax’s vaccine is not yet authorized for use in the United States. In January 2022, Novavax completed the submission of the final data package, including the complete chemistry, manufacturing and controls ("CMC") data module with the FDA for NVX-CoV2373.
The CMC submission is a prerequisite for the filing of emergency use authorization ("EUA") with the FDA. The company expects to file EUA for NVX-CoV2373 with the FDA shortly. Per FDA guidance, the EUA application is required to be submitted at least one month after the filing of the final data package to the FDA.
Novavax is currently evaluating NVX-CoV2373 in two pivotal phase III studies, namely the PREVENT-19 study, which has enrolled around 30,000 participants in the United States and Mexico, and another study in the United Kingdom, which has enrolled almost 15,000 participants. NVX-CoV2373 has demonstrated high efficacy with a reassuring safety profile in both these studies.
Novavax’s COVID vaccine is lagging behind J&J (JNJ - Free Report) , Moderna (MRNA - Free Report) and Pfizer (PFE - Free Report) /BioNTech, which have already launched their respective vaccines. The vaccines developed by these companies are not only approved for emergency use in the United States, but also authorized for use in many countries across the world.
Moderna and Pfizer/BioNTech’s vaccines are also approved in Israel.
While vaccines developed by Moderna and Pfizer/BioNTech are based on the mRNA technology and require a two-dose primary regimen, the vaccine developed by J&J is an anadenovirus-based one, only requiring a single-shot as primary regimen.
In fact, Pfizer, J&J and Moderna have also been granted EUA for the booster or third dose of their COVID vaccines by the FDA in all adults. The success of Pfizer, J&J and Moderna, with their respective COVID-19 jabs, will induce stiff competition for Novavax once NVX-CoV2373 is granted an EUA or a full approval.
Image: Shutterstock
Novavax (NVAX) Stock Rises on Deal for COVID-19 Jab in Israel
Shares of Novavax, Inc. (NVAX - Free Report) surged 13.7% on Jan 28 after the company announced that it has entered into an advance purchase agreement with Israel's Ministry of Health for the supply of its protein-based COVID-19 vaccine, NVX-CoV2373. Novavax’s vaccine has not yet been authorized in Israel.
Novavax’s shares were up in pre-market trading on Monday. However, the stock has plunged 69.1% in the past year compared with the industry’s decrease of 38.8%.
Per the latest advance purchase agreement, Novavax will initially supply five million doses of NVX-CoV2373 while the Ministry of Health in Israel will have the option to purchase an additional five million doses. Upon regulatory approval in Israel, Novavax and the Ministry of Health will finalize the distribution plans for NVX-CoV2373.
NVX-CoV2373 has already received approval for emergency use in multiple countries outside the United States. Novavax is currently marketing two versions of NVX-CoV2373 — one marketed in partnership with the Serum Institute of India under the trade name Covovax and another version produced by Novavax that is marketed under the trade name Nuvaxovid.
While Covovax is authorized for emergency use in India, Indonesia and the Philippines, Nuvaxovid was granted conditional marketing authorization in the European Union (EU) in December 2021.
The World Health Organization has granted emergency use listing to both Covovax and Nuvaxovid. Following this, the vaccine is now pre-qualified for supply to several countries participating through the COVAX facility.
However, Novavax’s vaccine is not yet authorized for use in the United States. In January 2022, Novavax completed the submission of the final data package, including the complete chemistry, manufacturing and controls ("CMC") data module with the FDA for NVX-CoV2373.
The CMC submission is a prerequisite for the filing of emergency use authorization ("EUA") with the FDA. The company expects to file EUA for NVX-CoV2373 with the FDA shortly. Per FDA guidance, the EUA application is required to be submitted at least one month after the filing of the final data package to the FDA.
Novavax is currently evaluating NVX-CoV2373 in two pivotal phase III studies, namely the PREVENT-19 study, which has enrolled around 30,000 participants in the United States and Mexico, and another study in the United Kingdom, which has enrolled almost 15,000 participants. NVX-CoV2373 has demonstrated high efficacy with a reassuring safety profile in both these studies.
Novavax’s COVID vaccine is lagging behind J&J (JNJ - Free Report) , Moderna (MRNA - Free Report) and Pfizer (PFE - Free Report) /BioNTech, which have already launched their respective vaccines. The vaccines developed by these companies are not only approved for emergency use in the United States, but also authorized for use in many countries across the world.
Moderna and Pfizer/BioNTech’s vaccines are also approved in Israel.
While vaccines developed by Moderna and Pfizer/BioNTech are based on the mRNA technology and require a two-dose primary regimen, the vaccine developed by J&J is an anadenovirus-based one, only requiring a single-shot as primary regimen.
In fact, Pfizer, J&J and Moderna have also been granted EUA for the booster or third dose of their COVID vaccines by the FDA in all adults. The success of Pfizer, J&J and Moderna, with their respective COVID-19 jabs, will induce stiff competition for Novavax once NVX-CoV2373 is granted an EUA or a full approval.
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.