Novavax
NVAX
announced that it has received a conditional marketing authorization (CMA) in Switzerland for the use of its protein-based COVID-19 vaccine NVX-CoV2373 in adults aged 18 years and above.
This CMA was granted by the Swiss health regulator 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%.
The vaccine will be manufactured and marketed under the trade name Nuvaxovid. The CMA granted in Switzerland also makes Nuvaxovid the first protein-based vaccine authorized for use in the country.
Novavax already has an advanced purchase agreement (APA) with the Swiss government to supply up to 6 million doses of its COVID vaccine. This was likely one of the reasons that led to a share price rise by7% following the announcement as NVAX would finally be able to execute this APA.
The stock has plunged 56.6% so far this year compared with the
industry
’s 11.9% decline.
Image Source: Zacks Investment Research
We remind investors that Nuvaxovid has already received authorization for use in multiple markets, including Australia, Canada and the European Union.
To enhance the reach of its COVID vaccine beyond the above markets and increase its manufacturing capabilities, Novavax markets another version of NVX-CoV2373 under the trade name Covovax in partnership with the Serum Institute of India. This version of the vaccine Covovax was granted authorization for an emergency use in Bangladesh, India, Indonesia and the Philippines. Last week, Covovax received authorization for emergency use in adults in Thailand.
Although Novavax continues to rack up authorizations across the globe, the vaccine is yet to be authorized in the United States. While NVAX already
submitted
a regulatory application to the FDA seeking an emergency use of NVX-CoV2373 in adults, a final decision by the regulatory agency is yet to be announced.
If approved in the United States, Novavax will face stiff competition from the large-cap pharma companies like
Moderna
MRNA
and
Pfizer
PFE
/
BioNTech
BNTX
, which developed their own COVID vaccines that not only dominate the market in the United States but also other markets across the globe.
We note that the vaccines developed by Moderna and Pfizer/BioNTech are based on the mRNA technology and require a two-dose primary regimen. In fact, the COVID vaccines developed by these companies are currently the only ones that received a full approval for use in adults in the United States.
The primary regimen of Pfizer/BioNTech’s COVID vaccine is already authorized in the United States as well as across many other countries for an emergency use in adolescents. Although Moderna’s COVID vaccine is yet to be granted authorization in the United States for use in adolescents, the same is already authorized for use in adolescents in many countries, including Europe and Canada.
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
.
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