The US Food and Drug Administration (FDA) has granted Fast Track designation for Pfizer and BioNTech’s messenger ribonucleic acid (mRNA)-based combination vaccine candidate against Covid-19 and influenza.
The vaccine is intended to prevent two respiratory ailments through a single injection.
In November, the companies announced plans for a Phase I clinical trial of the combined vaccine candidate in healthy adult subjects.
The first subject was dosed in the trial, which is designed to evaluate the safety, tolerability and immunogenicity of a nucleoside-modified RNA-based combination vaccine approach.
Based on the mRNA platform technology of BioNTech, the vaccine comprises strands of mRNA which encode the SARS-CoV-2 virus’ wild-type and BA.4/BA.5 Omicron sublineages spike proteins.
It also has mRNA strands that encode for the hemagglutinin of four influenza strains, recommended by the World Health Organization for the Northern Hemisphere 2022/23.
BioNTech noted that this combination vaccine for two respiratory ailments caused by viruses that need vaccine modification could streamline vaccination approaches.
Fast Track status aids in the development and speeds up the review of new therapies and vaccines for treating or preventing serious ailments.
Additionally, Health Canada has granted authorisation for Pfizer Canada and BioNTech’s 10μg booster dose of Comirnaty Original & Omicron BA.4/BA.5 for usage in children aged five to under 12 years.
The companies noted that the booster shot is indicated for use a minimum of six months following the initial vaccination series with the original Covid-19 vaccine, Comirnaty.
The latest development comes after the US FDA granted an amendment to the emergency use authorization (EUA) for the companies’ Omicron BA.4/BA.5-adapted bivalent Covid-19 vaccine for children aged six months to four years.
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
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