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Novavax (NVAX) Reports Positive Data on COVID/FLU Combo Jab Study
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Novavax (NVAX - Free Report) announced positive top-line results from a phase I/II study evaluating the safety and tolerability of its COVID-19-Influenza Combination (CIC) vaccine candidate.
The CIC vaccine candidate proved feasible, well-tolerated and immunogenic, inducing both antibody and T-cell responses against SARS-CoV-2 and homologous and heterologous influenza strains in the subjects. Serious adverse events were rare and were not related to the vaccine.
Post the announcement, Novavax shares were up 5.14% on Oct 13. However, shares of Novavax have declined 85.1% in the year-to-date period, compared with the industry’s decline of 25%.
Image Source: Zacks Investment Research
The CIC vaccine is a combination of Novavax’s COVID-19 vaccine NVX-CoV2373 and its seasonal influenza vaccine candidate, previously called NanoFlu, in a single formulation.
The safety and tolerability profile of the CIC vaccine candidate was consistent with the stand-alone NVX-CoV2373 vaccine (which induced CD4+ and CD8+ T-cell responses) and the quadrivalent influenza vaccine candidate (which induced CD4+ T-cell responses) reference formulations.
The positive results from the study provided important insights into the dose regimens, which can be utilized to progress the candidate in a phase II confirmation study. The company intends to initiate the phase II study by the end of 2022.
Investors are reminded that Novavax had announced initial results from the phase I/II study of the CIC vaccine candidate back in April 2022, where the CIC vaccine exhibited the potential to reduce total COVID-19 and influenza antigen amount by up to 50% overall.
Both the influenza vaccine and NVX-CoV2373 had previously demonstrated encouraging results in their separate phase III clinical studies.
Previously, NVAX announced data from a pivotal phase III study evaluating the influenza vaccine, which demonstrated positive top-line results and achieved statistical significance for the key secondary endpoints.
NVX-CoV2373 is already authorized for use in more than 40 countries, including Australia, Canada, European countries and India. Novavax also continues to garner authorizations for the use of its COVID-19 vaccine with additional label expansions for younger populations and as booster doses. The vaccine has started receiving authorizations for use in adolescents.
Though Novavax has gained authorization for the use of its COVID-19 vaccines in several countries globally, the COVID-19 vaccine market, specifically in the United States, is primarily dominated by big players such as Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) and Moderna (MRNA - Free Report) .
The vaccines developed by Moderna and Pfizer/BioNTech are based on mRNA technology and have been administered to millions across the globe.
The FDA authorized Pfizer/BioNTech and Moderna’s BA.4/BA.5 boosters for people 12 and older for Pfizer and 18 and older for Moderna in late August.
On Oct 12, the FDA expanded the eligibility of the granted emergency use authorization (EUA) to Omicron BA.4/BA.5-adapted bivalent vaccines developed by Pfizer/BioNTech andModerna. The vaccine would be used as a single booster dose in children as young as five years.
Moderna and Pfizer/BioNTech also intend to seek FDA’s authorization to use their vaccines in children aged six months and older.
Novavax currently holds a Zacks Rank #5 (Strong Sell).
Image: Shutterstock
Novavax (NVAX) Reports Positive Data on COVID/FLU Combo Jab Study
Novavax (NVAX - Free Report) announced positive top-line results from a phase I/II study evaluating the safety and tolerability of its COVID-19-Influenza Combination (CIC) vaccine candidate.
The CIC vaccine candidate proved feasible, well-tolerated and immunogenic, inducing both antibody and T-cell responses against SARS-CoV-2 and homologous and heterologous influenza strains in the subjects. Serious adverse events were rare and were not related to the vaccine.
Post the announcement, Novavax shares were up 5.14% on Oct 13. However, shares of Novavax have declined 85.1% in the year-to-date period, compared with the industry’s decline of 25%.
Image Source: Zacks Investment Research
The CIC vaccine is a combination of Novavax’s COVID-19 vaccine NVX-CoV2373 and its seasonal influenza vaccine candidate, previously called NanoFlu, in a single formulation.
The safety and tolerability profile of the CIC vaccine candidate was consistent with the stand-alone NVX-CoV2373 vaccine (which induced CD4+ and CD8+ T-cell responses) and the quadrivalent influenza vaccine candidate (which induced CD4+ T-cell responses) reference formulations.
The positive results from the study provided important insights into the dose regimens, which can be utilized to progress the candidate in a phase II confirmation study. The company intends to initiate the phase II study by the end of 2022.
Investors are reminded that Novavax had announced initial results from the phase I/II study of the CIC vaccine candidate back in April 2022, where the CIC vaccine exhibited the potential to reduce total COVID-19 and influenza antigen amount by up to 50% overall.
Both the influenza vaccine and NVX-CoV2373 had previously demonstrated encouraging results in their separate phase III clinical studies.
Previously, NVAX announced data from a pivotal phase III study evaluating the influenza vaccine, which demonstrated positive top-line results and achieved statistical significance for the key secondary endpoints.
NVX-CoV2373 is already authorized for use in more than 40 countries, including Australia, Canada, European countries and India. Novavax also continues to garner authorizations for the use of its COVID-19 vaccine with additional label expansions for younger populations and as booster doses. The vaccine has started receiving authorizations for use in adolescents.
Novavax, Inc. Price
Novavax, Inc. price | Novavax, Inc. Quote
Though Novavax has gained authorization for the use of its COVID-19 vaccines in several countries globally, the COVID-19 vaccine market, specifically in the United States, is primarily dominated by big players such as Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) and Moderna (MRNA - Free Report) .
The vaccines developed by Moderna and Pfizer/BioNTech are based on mRNA technology and have been administered to millions across the globe.
The FDA authorized Pfizer/BioNTech and Moderna’s BA.4/BA.5 boosters for people 12 and older for Pfizer and 18 and older for Moderna in late August.
On Oct 12, the FDA expanded the eligibility of the granted emergency use authorization (EUA) to Omicron BA.4/BA.5-adapted bivalent vaccines developed by Pfizer/BioNTech and Moderna. The vaccine would be used as a single booster dose in children as young as five years.
Moderna and Pfizer/BioNTech also intend to seek FDA’s authorization to use their vaccines in children aged six months and older.
Novavax currently holds a Zacks Rank #5 (Strong Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.