Shares of
Novavax
NVAX
were up 5.8% on Dec 30 after management announced that it initiated a phase II study to evaluate its COVID-19-Influenza Combination (CIC) and influenza standalone vaccine candidates.
The mid-stage study will evaluate the safety, tolerability and immunogenicity of different formulations of the CIC and influenza vaccine candidates in adults aged 50 through 80 years. The study will be conducted in two parts and will enroll nearly 2,300 participants.
The CIC vaccine combines NVX-CoV2373, Novavax’s authorized protein-based COVID vaccine, and its investigational influenza vaccine in a single formulation. Management believes that, like influenza, COVID-19 will be a seasonal infection and intends to target both indications through a single formulation.
Management plans to announce initial data from this study in mid-2023. Based on this data, Novavax will decide whether to advance these candidates to late-stage development.
Shares of Novavax have plunged 92.8% in the past year compared with the
industry
’s 21.0% fall.
Image Source: Zacks Investment Research
The initiation of this study was
based on positive data
, announced this October, from the phase I/II study on the CIC vaccine. Data from the study proved that the CIC vaccine was feasible, well-tolerated and immunogenic, inducing antibody and T-cell responses against SARS-CoV-2 and homologous and heterologous influenza strains in the subjects.
Initially, Novavax announced initial results from the phase I/II study of the CIC vaccine candidate back in April 2022. The CIC vaccine exhibited the potential to reduce total COVID-19 and influenza antigen amounts by up to 50% overall. The immune responses were comparable to the standalone influenza vaccine candidate and standalone NVX-CoV2373 formulations.
Though management conducted a late-stage study for its influenza vaccine, it had paused the development of the same and prioritized development of its COVID-19 vaccine at a time when the COVID-19 pandemic was at large.
Like Novavax, several other companies like
Pfizer
PFE
/
BioNTech
BNTX
and
Moderna
MRNA
are also developing combination vaccines targeting both influenza and COVID-19 indications.
Earlier this month, Pfizer along with partner BioNTech, announced that their mRNA-based vaccine candidate targeting influenza and COVID-19 was granted fast-track designation by the FDA. The vaccine combines Pfizer/BioNTech’s authorized Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine and their investigational quadrivalent modRNA-based influenza vaccine. Pfizer and BioNTech are currently evaluating the candidate in a phase I study that was initiated last month.
Moderna is evaluating mRNA-1073, its own mRNA-based combination vaccine, in a phase I/II study. mRNA-1073 is a combination of Spikevax (mRNA-1273), Moderna’s approved/authorized COVID-19 vaccine, and mRNA-1010, an investigational flu vaccine currently in phase III development. Moderna’s phase I/II study is evaluating mRNA-1073 to co-administered mRNA-1010 and mRNA-1273 and to mRNA-1010 and mRNA-1273 administered alone.
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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