(260) Preliminary Findings from a Non-Interventional Post-Authorization Safety Study (PASS) for Active Safety Surveillance of Comirnaty Vaccine Recipients in the EU
Background: In December 2020, the European Medicines Agency granted conditional marketing authorization to the Comirnaty vaccine for the prevention of SARS-CoV-2 infection in individuals 16+. Early in the pandemic, real-world safety surveillance following vaccination of individuals within the European Union (EU) was needed. Preliminary results as of 6 Jun 2022 from the second interim report shared with the regulator are presented herein.
Objectives: To estimate the real-world incidence of medically attended safety events of interest (MASEI) among individuals vaccinated with the Comirnaty monovalent vaccine in the EU.
Methods: This is a multisite, prospective, observational cohort study in which participants self-consent and self-report on their health status via a mobile app or with a call center, for up to 24 months after first Comirnaty receipt. Participants from Spain, Italy, and Germany were enrolled from sites based upon the regional availability and distribution of vaccine according to national or regional COVID 19 preparedness plans. This included physician offices, hospitals, pharmacies, and vaccination centers. Participants were required to be 18+. After consenting remotely, they self-enrolled on a participant-facing electronic platform within 5 days of their first vaccine. Participants were asked to self-report on a list of MASEI chosen based on the ACCESS program and SPEAC/Brighton Collaboration. Efforts to confirm events by a treating healthcare provider (HCP) were conducted. Incidence rates (IR) per 1,000 person-months and, if applicable, 95% Poisson exact confidence intervals ([ , ]) were obtained.
Results: As of 6 Jun 2022, there were n=1,398 participants. Participants were young (median: 31 yrs), and a similar distribution of females and males was included (F: 52%; M: 47%), with the majority self-reporting white race (60%). Baseline prevalence of each comorbidity was < 10%. Notably, the youngest participants were in Spain (median: 29 yrs; IQR=22-38), followed by Germany (34 yrs; IQR=28-40), then Italy (47 yrs; IQR=33-58). Overall, 33 (2.4%) participants experienced a MASEI (IR=4.7 [3.2,6.6]; Germany IR=4.3 [0.1, 24.1]; Italy IR=20.8 [12.3,32.9]; Spain IR=2.4 [1.3,4.0]). The most common MASEI (IR>0.5) IRs ranged from 0.7 and 1.3 and included: severe hospitalized COVID-19 disease, hospitalized arrythmia, non-anaphylactic allergic reactions, arthritis/arthralgia, acute respiratory distress syndrome, fatigue, malaise and myalgia/muscle pain.
Conclusions: Initial findings in this predominantly young, White, and healthy population indicate that a small proportion of study participants experienced a MASEI. Participant follow-up and HCP confirmation of MASEI are ongoing.
