Pfizer and BioNTech have commenced a Phase I clinical trial of the Covid-19 vaccine candidate BNT162b4, which aims to improve the T cell responses of the SARS-CoV-2 virus and potentially broaden protection against the disease.

The US-based trial will assess the safety, tolerability, and immunogenicity of the next-generation vaccine candidate in nearly 180 healthy individuals aged between 18 and 55 years.

These subjects have received a minimum of three mRNA-based Covid-19 vaccine doses.

Comprising a T cell antigen mRNA encoding for SARS-CoV-2 non-spike proteins, BNT162b4 will be evaluated along with the companies’ Omicron BA.4/BA.5-adapted bivalent Covid-19 vaccine.

Selected based on BioNTech’s target prioritisation platform, the non-spike proteins have been designed into a vaccine candidate to improve and broaden T-cell immunity.

The trial will analyse varying dose levels of the vaccine candidate administered along with a 30µg dose of the bivalent Covid-19 vaccine.

BNT162b4’s dose levels will also be compared to the administration of a 30µg dose of the bivalent Covid-19 vaccine as a booster.

The trial is part of the long-term and multi-pronged scientific strategy of Pfizer and BioNTech to generate strong, durable, and broader immune responses against the virus infections and associated Covid-19.

The companies are also developing several vaccines as part of this approach to deliver a potential pan-SARS-CoV-2 vaccine.

Comirnaty and BNT162b4, the Covid-19 vaccines of Pfizer and BioNTech, are based on the latter’s mRNA technology and were developed by both companies.

Pfizer and BioNTech recently reported data from a Phase II/III clinical trial of an Omicron BA.4/BA.5-adapted bivalent Covid-19 booster vaccine (Pfizer-BioNTech COVID-19 Vaccine, Bivalent [Original and Omicron BA.4/BA.5]).

The trial enrolled nearly 900 healthy subjects aged 12 years and above in the US.

Cell & Gene Therapy coverage on Clinical Trials Arena is supported by Cytiva.

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