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NVAX Stock Surges on Securing FDA Approval for COVID-19 Vaccine
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Shares of Novavax (NVAX - Free Report) surged nearly 26% in pre-market trading today after its protein-based COVID-19 vaccine, Nuvaxovid, received the long-awaited approval from the FDA, albeit with a narrower label than initially expected.
FDA’s Conditions on NVAX’s COVID-19 Jab
While the agency granted full approval to Nuvaxovid for use in older adults aged 65 and above, it restricted the vaccine’s use in individuals aged 12-64 with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.
In addition, the agency requires Novavax to conduct a new post-marketing phase IV study in individuals aged 50 through 64 without high-risk conditions for severe COVID-19.
The full approval is based on data from a pivotal late-stage study, which showed that Nuvaxovid was safe and effective for the prevention of COVID-19. Until now, the vaccine had been available for use under the FDA’s emergency use authorization.
NVAX Stock Performance
Year to date, Novavax’s shares have lost 16% against the industry’s 7% growth.
Image Source: Zacks Investment Research
How Does the Full Approval Benefit Novavax?
With the full approval, Nuvaxovid is the only non-mRNA-based COVID-19 vaccine available in the country. The company offers an alternative to mRNA-based vaccines marketed by Moderna (MRNA - Free Report) and Pfizer (PFE - Free Report) , both of which currently dominate this market space. This distinction could appeal to patients seeking a more traditional vaccine platform.
Starting this year, pharma giant Sanofi (SNY - Free Report) acquired exclusive rights to market Nuvaxovid globally, except in certain territories where Novavax maintains existing partnership agreements. This arrangement is part of a multi-billion-dollar deal signed last year, wherein Sanofi assumed commercial responsibility for the vaccine. According to one of the deal terms, the achievement of full approval for the COVID-19 vaccine triggers a $ 175-million milestone payment from Sanofi. NVAX is also eligible for ongoing tiered royalties on future sales of COVID-19 vaccines.
Ahead of this milestone, uncertainty surrounded the approval timeline after HHS secretary Robert F. Kennedy Jr. raised concerns about the vaccine’s efficacy. This contributed to a nearly two-month delay from the original April 1 decision deadline.
Novavax, along with partner Sanofi, said that it is on track to deliver the updated 2025-2026 formulation in time for the fall vaccination season, pending final strain recommendations from the FDA advisory committee meeting on May 22.
Unlike Pfizer and Moderna, Novavax was unable to capitalize on the pandemic's benefits due to a delayed launch of its COVID-19 vaccine. During last year’s vaccination season, sales of Novavax suffered due to the delayed approval of its vaccine formulation and a late product launch. Early participation in the upcoming vaccination season could help the company capitalize on the opportunity.
Image: Shutterstock
NVAX Stock Surges on Securing FDA Approval for COVID-19 Vaccine
Shares of Novavax (NVAX - Free Report) surged nearly 26% in pre-market trading today after its protein-based COVID-19 vaccine, Nuvaxovid, received the long-awaited approval from the FDA, albeit with a narrower label than initially expected.
FDA’s Conditions on NVAX’s COVID-19 Jab
While the agency granted full approval to Nuvaxovid for use in older adults aged 65 and above, it restricted the vaccine’s use in individuals aged 12-64 with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.
In addition, the agency requires Novavax to conduct a new post-marketing phase IV study in individuals aged 50 through 64 without high-risk conditions for severe COVID-19.
The full approval is based on data from a pivotal late-stage study, which showed that Nuvaxovid was safe and effective for the prevention of COVID-19. Until now, the vaccine had been available for use under the FDA’s emergency use authorization.
NVAX Stock Performance
Year to date, Novavax’s shares have lost 16% against the industry’s 7% growth.
Image Source: Zacks Investment Research
How Does the Full Approval Benefit Novavax?
With the full approval, Nuvaxovid is the only non-mRNA-based COVID-19 vaccine available in the country. The company offers an alternative to mRNA-based vaccines marketed by Moderna (MRNA - Free Report) and Pfizer (PFE - Free Report) , both of which currently dominate this market space. This distinction could appeal to patients seeking a more traditional vaccine platform.
Starting this year, pharma giant Sanofi (SNY - Free Report) acquired exclusive rights to market Nuvaxovid globally, except in certain territories where Novavax maintains existing partnership agreements. This arrangement is part of a multi-billion-dollar deal signed last year, wherein Sanofi assumed commercial responsibility for the vaccine. According to one of the deal terms, the achievement of full approval for the COVID-19 vaccine triggers a $ 175-million milestone payment from Sanofi. NVAX is also eligible for ongoing tiered royalties on future sales of COVID-19 vaccines.
Ahead of this milestone, uncertainty surrounded the approval timeline after HHS secretary Robert F. Kennedy Jr. raised concerns about the vaccine’s efficacy. This contributed to a nearly two-month delay from the original April 1 decision deadline.
Novavax, along with partner Sanofi, said that it is on track to deliver the updated 2025-2026 formulation in time for the fall vaccination season, pending final strain recommendations from the FDA advisory committee meeting on May 22.
Unlike Pfizer and Moderna, Novavax was unable to capitalize on the pandemic's benefits due to a delayed launch of its COVID-19 vaccine. During last year’s vaccination season, sales of Novavax suffered due to the delayed approval of its vaccine formulation and a late product launch. Early participation in the upcoming vaccination season could help the company capitalize on the opportunity.
Novavax, Inc. Price
Novavax, Inc. price | Novavax, Inc. Quote
NVAX’s 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.