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Novavax (NVAX) Down After FDA Raises Concern for Its COVID Jab
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Shares of Novavax (NVAX - Free Report) were down 20% following a briefing document issued by the FDA on its COVID-19 vaccine for the upcoming Vaccines and Related Biological Products Advisory Committee(VRBPAC) meeting, scheduled on Jun 7. The vaccine is yet to be authorized for use in the United States.
The VRBPAC is set to give a recommendation on NVAX’s regulatory filing, seeking an emergency use authorization (EUA) for NVX-CoV2373, the latter’s protein-based COVID-19 vaccine.
The FDA briefing document, issued ahead of the VRBPAC meeting, reports multiple events of heart inflammation diseases like myocarditis/pericarditis in some study participants who were administered the NVX-CoV2373 vaccine. Based on these events, the FDA document warns that an administration of Novavax’s COVID-19 vaccine may have a causal relationship with these heart diseases.
However, the FDA document does not confirm the existence of this relationship between the vaccine and the heart problems. The regulatory agency believes that further evidence will be required to establish this relationship.
Novavax issued a statement based on the above concerns raised by the FDA. Management stated that the adverse events like myocarditis are often caused by non-specific viral infections. NVAX also believes that there is insufficient evidence to establish a causal relationship between its vaccine and the above-mentioned events.
This interpretation of Novavax is supported by data from the clinical development program it conducted on its COVID-19 vaccine, which shows that the rate of myocarditis was well balanced between the vaccine and the placebo arms.
Shares of Novavax have plunged 68.7% so far this year compared with the industry’s 24% decline.
Image Source: Zacks Investment Research
We remind investors that the FDA filing was submitted by NVAX earlier this year in January. The filing is based on data from the two pivotal phase III studies on the vaccine, one (PREVENT-19) conducted in the United States and Mexico, while another in the United Kingdom. The PREVENT-19 study achieved an overall vaccine efficacy of 90.4%, while data from the study conducted in the United Kingdom demonstrated that the vaccine achieved an overall efficacy of 89.7%.
Novavax’s COVID vaccine already received authorization for use in multiple countries, including Australia, Canada, Europe and India. NVAX is currently marketing two versions of NVX-CoV2373, one marketed in partnership with the Serum Institute of India under the trade name Covovax while another version is produced by it and marketed under the trade name Nuvaxovid.
Currently, the COVID-19 vaccine market in the United States is being dominated by pharma giants like Moderna (MRNA - Free Report) and Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) with NVAX trailing way behind.
The two vaccines developed by Moderna and Pfizer/BioNTech are based on the mRNA technology, which at present, exclusively received full approval for use in adults in the United States. The booster doses of these vaccines are also authorized for use in adults.
The primary regimen of Pfizer/BioNTech’s COVID vaccine is currently the only one authorized for use in individuals aged five years and above in the United States. The third dose of the Pfizer/BioNTech vaccine is also the only one allowed for use in individuals aged 12 years and above.
Although Moderna’s vaccine is yet to be authorized for use in individuals under 18 years of age (either as a primary regimen or a booster dose) in the United States, its management already submitted regulatory applications to this end, which are currently under the FDA review.
Additionally, the FDA authorized the use of a second booster dose of Moderna and Pfizer/BioNTech vaccines in older individuals (aged 50 years and beyond) as well as in certain immunocompromised individuals aged 18 years and above.
Image: Shutterstock
Novavax (NVAX) Down After FDA Raises Concern for Its COVID Jab
Shares of Novavax (NVAX - Free Report) were down 20% following a briefing document issued by the FDA on its COVID-19 vaccine for the upcoming Vaccines and Related Biological Products Advisory Committee(VRBPAC) meeting, scheduled on Jun 7. The vaccine is yet to be authorized for use in the United States.
The VRBPAC is set to give a recommendation on NVAX’s regulatory filing, seeking an emergency use authorization (EUA) for NVX-CoV2373, the latter’s protein-based COVID-19 vaccine.
The FDA briefing document, issued ahead of the VRBPAC meeting, reports multiple events of heart inflammation diseases like myocarditis/pericarditis in some study participants who were administered the NVX-CoV2373 vaccine. Based on these events, the FDA document warns that an administration of Novavax’s COVID-19 vaccine may have a causal relationship with these heart diseases.
However, the FDA document does not confirm the existence of this relationship between the vaccine and the heart problems. The regulatory agency believes that further evidence will be required to establish this relationship.
Novavax issued a statement based on the above concerns raised by the FDA. Management stated that the adverse events like myocarditis are often caused by non-specific viral infections. NVAX also believes that there is insufficient evidence to establish a causal relationship between its vaccine and the above-mentioned events.
This interpretation of Novavax is supported by data from the clinical development program it conducted on its COVID-19 vaccine, which shows that the rate of myocarditis was well balanced between the vaccine and the placebo arms.
Shares of Novavax have plunged 68.7% so far this year compared with the industry’s 24% decline.
Image Source: Zacks Investment Research
We remind investors that the FDA filing was submitted by NVAX earlier this year in January. The filing is based on data from the two pivotal phase III studies on the vaccine, one (PREVENT-19) conducted in the United States and Mexico, while another in the United Kingdom. The PREVENT-19 study achieved an overall vaccine efficacy of 90.4%, while data from the study conducted in the United Kingdom demonstrated that the vaccine achieved an overall efficacy of 89.7%.
Novavax’s COVID vaccine already received authorization for use in multiple countries, including Australia, Canada, Europe and India. NVAX is currently marketing two versions of NVX-CoV2373, one marketed in partnership with the Serum Institute of India under the trade name Covovax while another version is produced by it and marketed under the trade name Nuvaxovid.
Currently, the COVID-19 vaccine market in the United States is being dominated by pharma giants like Moderna (MRNA - Free Report) and Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) with NVAX trailing way behind.
The two vaccines developed by Moderna and Pfizer/BioNTech are based on the mRNA technology, which at present, exclusively received full approval for use in adults in the United States. The booster doses of these vaccines are also authorized for use in adults.
The primary regimen of Pfizer/BioNTech’s COVID vaccine is currently the only one authorized for use in individuals aged five years and above in the United States. The third dose of the Pfizer/BioNTech vaccine is also the only one allowed for use in individuals aged 12 years and above.
Although Moderna’s vaccine is yet to be authorized for use in individuals under 18 years of age (either as a primary regimen or a booster dose) in the United States, its management already submitted regulatory applications to this end, which are currently under the FDA review.
Additionally, the FDA authorized the use of a second booster dose of Moderna and Pfizer/BioNTech vaccines in older individuals (aged 50 years and beyond) as well as in certain immunocompromised individuals aged 18 years and above.
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.