Pfizer and BioNTech said they have begun a clinical study to evaluate the safety, tolerability, and immunogenicity of an Omicron-based vaccine candidate in healthy adults 18-55 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.
The study will evaluate up to 1,420 participants across the three cohorts:
- 615 participants who 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
- 600 participants who 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
- 205 unvaccinated participants who will receive three doses of the Omicron-based vaccine
“The companies have previously announced that they expect to produce four billion doses of the Pfizer-BioNTech COVID-19 Vaccine in 2022, and this capacity is not expected to change if an adapted vaccine is required,” Pfizer and BioNTech said in a news release.
