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Novavax (NVAX) COVID Jab Gets Nod for Emergency Use in India
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Novavax (NVAX - Free Report) announced that it has received emergency use authorization (EUA) for its protein-based COVID-19 vaccine, NVX-CoV2373, in India.
The vaccine will be manufactured and marketed in India by the Serum Institute of India (SII) under the brand name Covovax.
Shares of Novavax have rallied 39.8% so far this year against the industry’s 20.4% decline.
Image Source: Zacks Investment Research
Novavax is currently marketing two versions of NVX-CoV2373 — one marketed with SII under the trade name Covovax and another version produced by NVAX that is marketed under the trade name Nuvaxovid.
Last month, Covovax was authorized for emergency use in Indonesia and the Philippines.
Earlier this month, the World Health Organization granted emergency use listing (EUL) to both Covovax and Nuvaxovid. Following the grant of EUL, the vaccine is now pre-qualified for supply to numerous countries participating through the COVAX facility. Novavax and SII already have an agreement to jointly supply 1.1 billion doses of NVX-CoV2373 to Gavi through the COVAX facility.
Nuvaxovid was granted conditional marketing authorization in the European Union (EU) last week. Novavax already has an advanced purchase agreement with the European Commission 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.
We expect Novavax to start recording revenues on account of these approvals and supply agreements in the initial quarters of 2022.
Meanwhile, the company has submitted regulatory filings seeking approval for the NVX-CoV2373 in multiple markets, which include Australia, Canada, Japan, New Zealand, South Korea, UAE and the United Kingdom. Novavax 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 an impetus to the top line.
Novavax is yet to apply in the United States for EUA of its COVID vaccine. The company reiterated its plans to submit the complete chemistry, manufacturing and controls data package to the FDA for the same by 2021-end.
Although Novavax’s COVID vaccine shows promise and is currently garnering approvals across multiple nations, the company faces stiff competition from the vaccines developed by AstraZeneca (AZN - Free Report) and Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) . In fact, the vaccines developed by these companies have already received approval or EUA in various parts of the world and vaccinations are in full swing.
AstraZeneca has developed its COVID-19 vaccine, Vaxzevria (AZD1222), in partnership with the University of Oxford.
We remind investors that AstraZeneca’s Vaxzevria is already manufactured and marketed in India by SII under the trade name Covishield.
Comirnaty, an mRNA-based COVID-19 vaccine, has been developed by Pfizer in collaboration with BioNTech.
This August, Pfizer/BioNTech’s Comirnaty, became the first COVID-19 vaccine to secure full approval from the FDA for individuals aged 16 years and older. The vaccine has also been granted EUA by the FDA for use in individuals aged five years and above.
Pfizer/BioNTech’s Comirnaty has also been approved for emergency/temporary use in several countries worldwide including the EU. Earlier this month, both Pfizer and BioNTech entered into an agreement with the European Commission to supply 200 million doses of Comirnaty to EU member states.
Image: Shutterstock
Novavax (NVAX) COVID Jab Gets Nod for Emergency Use in India
Novavax (NVAX - Free Report) announced that it has received emergency use authorization (EUA) for its protein-based COVID-19 vaccine, NVX-CoV2373, in India.
The vaccine will be manufactured and marketed in India by the Serum Institute of India (SII) under the brand name Covovax.
Shares of Novavax have rallied 39.8% so far this year against the industry’s 20.4% decline.
Novavax is currently marketing two versions of NVX-CoV2373 — one marketed with SII under the trade name Covovax and another version produced by NVAX that is marketed under the trade name Nuvaxovid.
Last month, Covovax was authorized for emergency use in Indonesia and the Philippines.
Earlier this month, the World Health Organization granted emergency use listing (EUL) to both Covovax and Nuvaxovid. Following the grant of EUL, the vaccine is now pre-qualified for supply to numerous countries participating through the COVAX facility. Novavax and SII already have an agreement to jointly supply 1.1 billion doses of NVX-CoV2373 to Gavi through the COVAX facility.
Nuvaxovid was granted conditional marketing authorization in the European Union (EU) last week. Novavax already has an advanced purchase agreement with the European Commission 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.
We expect Novavax to start recording revenues on account of these approvals and supply agreements in the initial quarters of 2022.
Meanwhile, the company has submitted regulatory filings seeking approval for the NVX-CoV2373 in multiple markets, which include Australia, Canada, Japan, New Zealand, South Korea, UAE and the United Kingdom. Novavax 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 an impetus to the top line.
Novavax is yet to apply in the United States for EUA of its COVID vaccine. The company reiterated its plans to submit the complete chemistry, manufacturing and controls data package to the FDA for the same by 2021-end.
Although Novavax’s COVID vaccine shows promise and is currently garnering approvals across multiple nations, the company faces stiff competition from the vaccines developed by AstraZeneca (AZN - Free Report) and Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) . In fact, the vaccines developed by these companies have already received approval or EUA in various parts of the world and vaccinations are in full swing.
AstraZeneca has developed its COVID-19 vaccine, Vaxzevria (AZD1222), in partnership with the University of Oxford.
We remind investors that AstraZeneca’s Vaxzevria is already manufactured and marketed in India by SII under the trade name Covishield.
Comirnaty, an mRNA-based COVID-19 vaccine, has been developed by Pfizer in collaboration with BioNTech.
This August, Pfizer/BioNTech’s Comirnaty, became the first COVID-19 vaccine to secure full approval from the FDA for individuals aged 16 years and older. The vaccine has also been granted EUA by the FDA for use in individuals aged five years and above.
Pfizer/BioNTech’s Comirnaty has also been approved for emergency/temporary use in several countries worldwide including the EU. Earlier this month, both Pfizer and BioNTech entered into an agreement with the European Commission to supply 200 million doses of Comirnaty to EU member states.
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.