COVID-19: First trial outside US for Omicron vaccines kicks off

The study will evaluate the safety, tolerability and immunogenicity of a higher dose of the Pfizer-BioNTech COVID-19 vaccine as well as the experimental Omicron vaccine.

Main entrance to the Sheba Medical Center at Tel Hashomer (photo credit: Wikimedia Commons)
Main entrance to the Sheba Medical Center at Tel Hashomer
(photo credit: Wikimedia Commons)

Sheba Medical Center, which is the largest hospital in Israel, will enroll its first study outside the US for vaccine candidates to combat the Omicron variant and other variants that may emerge in the future.

The study, developed in collaboration with Pfizer and approved by the Israeli Health Ministry and Helsinki Committee, will evaluate the safety, tolerability and immunogenicity of a higher dose of the Pfizer-BioNTech COVID-19 vaccine.

Researchers will further examine Pfizer’s experimental Omicron vaccine, as well as a treatment for adults aged 60 and older that combines both the existing vaccine and the experimental Omicron vaccine as a fourth dose.

Approximately 200 participants will enroll, all of whom have received their booster doses more than four months before the study begins. These participants will further become a part of Sheba’s larger, ongoing serological research cohort, which has so far includes over 6,000 participants.

Sheba Medical Center campus (credit: Courtesy)Sheba Medical Center campus (credit: Courtesy)

"This trial is extremely important as the world continues to deal with and battle these variants and perhaps others in the future,” said Prof. Gili Regev-Yochay, director of the Infection Prevention & Control Unit at Sheba. “Vaccinations are the only way to roll back the global coronavirus pandemic," Regev-Yochay concluded.

Sheba Medical Center was ranked as the 10th best hospital in the world by Newsweek in 2021 – falling from 9th place in 2020. Both spots made Sheba the highest-ranked hospital in Israel.