Pfizer + BioNTech initiate study to evaluate Omicron-based COVID-19 vaccine in adults 18 to 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 III COVID-19 booster study and is part of their ongoing efforts to address Omicron and determine the potential need for variant-based vaccines.

The study will evaluate up to 1,420 participants across the three cohorts: i. Cohort #1 (n = 615): 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. ii. Cohort #2 (n = 600): 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. iii. Cohort #3 (n=205): Vaccine-naïve participants will receive three doses of the Omicron-based vaccine.

Clinical and real-world data continue to find people who are vaccinated, particularly those that have received a booster, maintain a high level of protection against Omicron, particularly against severe disease and hospitalization. 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.