According to the companies, the trial will evaluate the safety, tolerability, and immune response of the vaccine that can be administered as a primary shot and a booster.
Pfizer and BioNTech have initiated a clinical trial to evaluate their Omicron-specific COVID-19 vaccine.
In a January 25 press release, they announced that the trial will evaluate the safety, tolerability, and immune response of the vaccine that can be administered as a primary shot and a booster.
The study will include more than 1400 adults
The study includes the following 3 patient cohorts: 1, those who had 2 vaccinations with the Pfizer formulation 90 to 180 days before inclusion in the study under discussion; 2, those who had 3 doses of the Pfizer formulation with the same time frame, and 3, those who did not receive any vaccine for COVID-19.
Cohorts 1, 2, and 3, will receive the following respective doses of the Omicron-specific vaccine: 1 or 2 doses, 1 dose, and 3 doses. Each dose is 30 micrograms.
Pfizer Senior Vice President and Head of Vaccine Research and Development Kathrin Jansen commented in the press release,
"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,” Pfizer Senior Vice President and Head of Vaccine Research and Development Kathrin Jansen stated in the release.
Manufacturing of the Omicron-specific vaccine is already underway.
According to the companies, production of the current Pfizer-BioNTech vaccine will continue according to plan. The current formulation provides protection against Omicron for 4 months after patients receive the third dose of the Pfizer/BioN/Tech shot.