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This is a Pfizer-sponsored study developed in collaboration with Sheba, and approved by the regulatory health authorities, including the Israeli Ministry of Health, Helsinki Committee, which oversees human clinical trials.
The study will evaluate the safety, tolerability, and immunogenicity of a higher dose of the Pfizer-BioNTech COVID-19 Vaccine (60 μg), the companies’ investigational Omicron-based vaccine (60 μg), and a combination of both vaccines (30 μg each, and 15 μg each) given as a fourth in adults 60-years-of-age and older.
Approximately 200 participants will enroll in the study. Participants all previously received three doses of the current vaccine, with the most recent dose being >4 months prior to enrollment. These participants will be part of the larger, ongoing serological research at Sheba (i.e. part of the cohort), which has involved 6000 medical personnel during the advent of the vaccine campaign.
Professor Gili Regev-Yochay, Director of the Infection Prevention & Control Unit at Sheba Medical Center added, “This trial is extremely important as the world continues to deal with and battle these variants and perhaps others in the future. Vaccinations are the only way to roll- back the global coronavirus pandemic.”