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# Pfizer/BioNTech Studying Next Gen Covid Vaccine
- URL: https://www.fdaweb.com/pfizer-biontech-studying-next-gen-covid-vaccine/
- Published: 2022-11-17T12:00:00.000Z
- Updated: 2026-09-14T18:06:51.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5153225

Pfizer and BioNTech have begun a Phase 1 study of their next-generation Covid-19 vaccine that they say is designed to “enhance SARS-CoV-2 T cell responses and potentially broaden protection against Covid-19.” The study is part of the companies’ strategy to generate more robust, longer-lasting, and broader immune responses against Covid infections and severe illness. “As part of this approach the companies are developing [multiple vaccine candidates](https://www.globenewswire.com/Tracker?data=V1zdErskB8szxGrEd7j0sMWrW6cwPesSIOcs6cBV%5FE8iQ4BtfNnrwp0CA4bUaUJ3LzJyscMqlJlzHEpDsMKmPCzMgtRMEU9Ydk5CXLyh%5FkKV0MRsAz5b3SlhQe6MtvqIV0rqZFOGMUV1s2gPvCsa7DMMAKp5suAbnn4j4aYiva9K9odtAYXRdDR07OYXPyMN5Kq2A%5FdeEplN8Y9lVE2oFFJV8HfMI7hcLNwTU7hDQyI=&ref=fdaweb.com) with the aim of delivering a potential pan-SARS-CoV-2 vaccine,” they say in a news release.

The investigational vaccine, BNT162b4, comprises a “T cell antigen mRNA encoding for SARS-CoV-2 non-spike proteins that are highly conserved across a broad range of SARS-CoV-2 variants and will be evaluated in combination with the companies’ Omicron BA.4/BA.5-adapted bivalent Covid-19 vaccine,” they explain. “These non-spike proteins have been chosen based on BioNTech's proprietary target prioritization platform and were designed into a vaccine candidate with the purpose of enhancing and broadening T cell immunity and potentially extending durability of protection against Covid-19.”

The U.S. study ([NCT05541861](https://www.globenewswire.com/Tracker?data=VVjxgDnkDnYheNQoI-yZdi%5F6b9Qn821NvPq-JyhfRiu7VrFejKnNfPz5etZjZDyTc7L4aMU5gbe8c7TkOsdjR7ZRV%5FNmm2caAWYNXrquQFWIkc8l%5FXHarGmLhqgMnx1jPXZzZsN2lJ3NN9627uYayw==&ref=fdaweb.com)) is enrolling about 180 healthy individuals between 18 and 55 years of age, who have received at least three doses of an mRNA-based CoviD-19 vaccine. The trial will analyze different vaccine dose levels of the new vaccine administered in combination with a 30-µg dose of the companies’ Omicron BA.4/BA.5-adapted bivalent CoviD-19 vaccine and will be compared to the bivalent Covid-19 vaccine as a booster.