2 ．Large Scale Cohort Study in Practice

<p>Cohort Survey at the Beginning of SARS-CoV-2 Vaccination in Japan was planned as an administrative promotion survey project for the purpose of promptly disclosing safety information on SARS-CoV-2 vaccination to the council of the Ministry of Health, Labor and Welfare.</p><p>The cohort survey of initial series of Pfizer Comirnaty was started on February 17, 2021. In order to conduct the multi-institutional joint research as an observational study in compliance with the ethical guidelines for medical research on human subjects, we used a commercial IRB. We prepared for a research platform including an EDC, research management services, and cooperation with Organization headquarters. Comirnaty was vaccinated on approximately 20,000 healthcare workers over a nine-day period and the first interim report was published on March at the council of the MHLW. Then the cohort survey of initial series of Moderna Spikevax on SDF personnel and AstraZeneca VAXZEVRIA on the general public were started on May and August 2021, respectively. In addition, investigations on the third additional vaccination from December 2021, vaccines for children aged 5-11 years from March 2022, and Takeda/Novavax vaccines from May 2022 and the fourth additional vaccination from May 2022 were not only conducted as safety investigations, but also the changes in antibody titers of some of the subjects were examined. The results have been reported 23 times (as of July 8, 2022) to the council of the MHLW. The database includes specific adverse events such as fever, local pain, fatigue, and headache etc. and MedDRA-coded free-text adverse events, number of sick leave, number of drugs used for adverse reactions, antibody titer trends, and serious adverse events including PMDA reports.</p>