January 25, 2022 – Pfizer and BioNTech announced the initiation of a clinical study to evaluate the safety, tolerability and immunogenicity of an omicron-based vaccine candidate in healthy adults 18 through 55 years of age. The study will have three cohorts examining different regimens of the current Pfizer-BioNTech COVID-19 vaccine or an omicron-based vaccine. The study will draw upon some participants from the companies’ Phase 3 COVID-19 booster study and is part of their ongoing efforts to address omicron and determine the potential need for variant-based vaccines.
“While current research and real-world data show that boosters continue to provide a high level of protection against severe disease and hospitalization with Omicron, we recognize the need to be prepared in the event this protection wanes over time and to potentially help address Omicron and new variants in the future,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development at Pfizer. “Staying vigilant against the virus requires us to identify new approaches for people to maintain a high level of protection, and we believe developing and investigating variant-based vaccines, like this one, are essential in our efforts to towards this goal.”
The study will evaluate 1,420 participants across three categories
- Received two doses of the current Pfizer-BioNTech COVID-19 vaccine 90-180 days prior to enrollment; in the study, participants will receive one or two doses of the Omicron-based vaccine
- Received three doses of the current Pfizer-BioNTech COVID-19 vaccine 90-180 days prior to enrollment; in the study, participants will receive one dose of the current Pfizer-BioNTech COVID-19 vaccine or the Omicron-based vaccine
- Vaccine-naïve participants will receive three doses of the Omicron-based vaccine