Novavax
NVAX
announced positive preliminary results from a phase I/II study, which is evaluating the safety and immunogenicity of its COVID-19-influenza combination (CIC) vaccine candidate.
The CIC vaccine is a combination of Novavax’s COVID-19 vaccine NVX-CoV2373 and its seasonal influenza vaccine candidate NanoFlu in a single formulation.
Initial results from the phase I/II study demonstrated that formulating a combination of NVX-CoV2373 and NanoFlu was feasible and immunogenic. The safety profile of the CIC vaccine was also similar to the standalone vaccines.
In fact, numerous CIC vaccine formulations tested under the study led to immune responses in study participants, which were comparable to standalone NanoFlu and standalone NVX-CoV2373 formulations.
The CIC vaccine also exhibited the potential to reduce total COVID-19 and influenza antigen amount by up to 50% overall, which means the production can be optimized. Based on these results, Novavax intends to advance the CIC vaccine to a phase II dose confirmation study by this year-end.
Shares of Novavax have plunged 62.5% so far this year compared with the
industry
’s 14.7% decline.
Both NanoFlu and NVX-CoV2373 already demonstrated encouraging results in their separate phase III clinical studies.
NVAX announced positive top-line data in March 2020 from a pivotal phase III study, which demonstrated both the efficacy and the safety of NanoFlu. The study met all the primary goals and achieved statistical significance for the key secondary endpoints as well.
NVX-CoV2373 already received authorization for use in multiple markets, including Australia, Canada, Europe and India. Based on the authorizations that NVAX received for its COVID-19 vaccine, management expects total 2022 revenues in the range of $4.0-$5.0 billion.
However, NVX-CoV2373 is not yet authorized for use in the U.S. market. Though NVAX
submitted
a regulatory application in January this year to the FDA, seeking an emergency use of NVX-CoV2373 in adults, a final decision by the regulatory agency is yet to be announced.
Currently, the COVID-19 vaccine market in the United States is dominated by large-cap pharma giants like
Moderna
MRNA
and
Pfizer
PFE
/
BioNTech
BNTX
. If NVX-CoV2373 is approved, Novavax will face stiff competition from these companies for market share in the country.
The vaccines developed by Moderna and Pfizer/BioNTech are based on the mRNA technology and require a two-dose primary regimen. The COVID vaccines developed by Moderna and Pfizer/BioNTech are currently the only ones that received full approval for use in adults in the United States.
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 FDA is currently reviewing Moderna’s regulatory filing, which seeks authorization for the use of its vaccine in individuals aged under 18.
Zacks Rank
Novavax currently carries a Zacks Rank #3 (Hold). You can see
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