Pfizer
PFE
announced that the FDA granted fast-track designation to its early-stage mRNA-based vaccine candidate targeting influenza and COVID-19. The vaccine is being developed in collaboration with
BioNTech
BNTX
.
Fast Track is designed to facilitate the development and acceleration of the review of drugs to treat serious conditions and fill an unmet medical need or offer a potential advantage over the existing treatments. A candidate granted Fast Track designation is also eligible for rolling review.
The vaccine is a combination of Pfizer/BioNTech’s authorized Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine and their investigational quadrivalent modRNA-based influenza vaccine. It is currently being evaluated in a phase III study.
Shares of Pfizer have lost 6.3% in the year so far against the
industry
’s 16.3% rise.
Image Source: Zacks Investment Research
Last month, Pfizer and BioNTech initiated a phase I study to evaluate the safety, tolerability, and immunogenicity of this COVID-19/influenza combination vaccine in 180 healthy study participants aged 18 through 64 years.
Through their combination vaccine, Pfizer/BioNTech aim to simplify immunization practices against two respiratory diseases caused by evolving viruses that require vaccine adaptation.
Like Pfizer/BioNTech, several other companies like
Moderna
MRNA
and
Novavax
NVAX
are also developing their combination vaccines targeting both influenza and COVID-19 indications in early-stage development.
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.
Novavax is also evaluating a COVID-19-influenza combination (CIC) vaccine candidate in a phase I/II study. The CIC vaccine combines NVX-CoV2373, its authorized protein-based COVID vaccine, and its investigational influenza vaccine in a single formulation. In October, Novavax announced top-line data from this study which demonstrated the CIC vaccine was feasible and immunogenic. The immune responses were comparable to the standalone influenza vaccine candidate and standalone NVX-CoV2373 formulations. Novavax expects to begin a confirmatory phase II study evaluating this vaccine by this year’s end.
Zacks Rank
Pfizer 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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