ABSTRACT
Introduction: COVID-19 vaccines were rapidly authorized leaving many questions and the need to monitor safety intensively. Objective(s): Multi-national collaboration was established with the aim to monitor the safety of the COVID-19 vaccines through prospective cohort event monitoring in Europe. Method(s): A prospective cohort event monitoring study was conducted with primary consented data collection in seven countries between December 2020 and November 2021. Participants in Belgium, France, Italy, the Netherlands and United Kingdom registered using the LIM web app and received follow-up questionnaires for six months. Participants from Croatia and Germany registered with the OPeN and SafeVac2.0 apps respectively. Rates of self-reported reactions were described by type (solicited, non-solicited), adverse event of special interest (AESI), seriousness, and stratified by vaccine brand. The rate of self-reported adverse reaction was calculated after dose 1 and prior to dose 2 among all subjects who responded with at least one questionnaire. Result(s): 117,791 participants were included and responded to the first questionnaires after baseline: 88,196 from Germany, 27,588 from the Netherlands, 984 from France, 570 from Italy, 326 from Croatia, 89 from the United Kingdom and 38 from Belgium. 89,377 respondents received AstraZeneca, 14,658 BioNTech/Pfizer, 11,266 Moderna and 2490 Janssen. Reporting included all vaccine brands from all countries, except Germany which only included data on Moderna until May 2021 and AstraZeneca until September 2021. Median time to completion was 8 days for the first questionnaire after dose 1 (Netherlands, Belgium, Italy, France, United Kingdom) and 3 days in Croatia. Median age category was 40-49 for all vaccine exposed groups except for BioNtech/Pfizer where median age was 70-79. Fatigue and headache were the most commonly reported solicited systemic adverse reactions, injection site reactions the most common solicited local reaction. AESIs were very rare (<0.1%) and serious adverse reactions were uncommon (<1%) across all vaccine brands. Conclusion(s): This study that collated self-reported data from more than 100,000 COVID-19 vaccine recipients, demonstrated feasibility of setting up and conducting cohort event monitoring across multiple European countries to collect safety data on novel vaccines that are rolled out at scale in populations which may not have been included in pivotal trials. Different vaccination schedules in countries and different web applications resulted in some heterogeneity. The study confirmed the safety information in the product labels: reactogenic reactions, related to immunogenic response, and local injection site reactions were very common across all vaccines, whereas serious reactions or AESIs were (very) rare.
ABSTRACT
Introduction: Since the WHO declared the COVID-19 global pandemic in March 2020, vaccines to prevent severe SARS-CoV-2 infection have been developed at unprecedented speed. Several vaccines have been conditionally authorized by regulators in December 2020 already. The large-scale vaccination campaigns have undeniably raised the importance of post-authorization evaluations not only through spontaneous reporting but also by cohort event monitoring to obtain more in-depth vaccine safety information, rapidly after launch. Objective: To monitor COVID-19 vaccine safety and estimate the frequency of solicited and non-solicited, non-serious and serious reactions. Methods: We designed a prospective cohort event monitoring (CEM) study as part of the Covid-Vaccine-Monitor (CVM) project. The CEM collects baseline data, adverse reactions (ADRs) of authorized COVID-19 vaccines in the general and special populations (pregnant and lactating women, children, and adolescents, immunocompromised, allergic, and prior COVID-19 infection people) in twelve countries (Germany, Croatia, Netherlands, Belgium, Italy, France, Spain, Portugal, Slovakia, Romania, Switzerland, and UK). The current results comprise data from February 2021-February 2022. Depending on the dose and cohort, two data collection platforms are used: the Lareb-managed Intensive Monitoring (LIM) and the UMC Utrecht Research Online (RO). Germany and Croatia used their national tools. Participants meet local age criteria, have a first vaccination cycle or a booster dose within 48 hours, and are followed up for 6 months. Data are pooled, stratified by special cohorts, and analyzed. Results: We included more than 30,000 general population participants data from Belgium, Croatia, France, Italy, Netherlands, and UK, and more than 520,000 from Germany with the first vaccinations. Across different vaccines, 0.2-0.3% reported at least one serious ADR after receiving the first doses. More than 7,400 special cohorts vaccinees participated. 0.2% and 0.4% reported at least one serious ADR and adverse event of special interest (AESI), respectively, after the first vaccinations. The most-reported ADRs among vaccines were injection site pain, locally, and fatigue, headache, malaise, and myalgia, systemically. Serious ADRs and AESIs were uncommon. More than 11,100 vaccinees from general and special cohorts receiving a booster dose were also included. Among different cohorts, children/adolescents reported the lowest number of ADRs, while lactating women reported the highest. Conclusion: We collected and analyzed COVID-19 vaccines safety evidence in more than 550,000 general and special population persons after the first cycle and booster doses, combining data from twelve countries. Data confirm common ADR rates that are already listed in the summary of product characteristics, and that serious reactions are uncommon. Additional follow-up is ongoing.
ABSTRACT
Introduction: COVID-19 vaccines were rapidly authorized leaving many questions and the need to monitor safety intensively. Objective: Multi-national collaboration was established with the aim to monitor the safety of the COVID-19 vaccines through prospective cohort event monitoring in Europe. Methods: A prospective cohort event monitoring study was con- ducted with primary consented data collection in seven countries between December 2020 and November 2021. Participants in Bel- gium, France, Italy, the Netherlands and United Kingdom registered using the LIM web app and received follow-up questionnaires for six months. Participants from Croatia and Germany registered with the OPeN and SafeVac2.0 apps respectively. Rates of self-reported reactions were described by type (solicited, non-solicited), adverse event of special interest (AESI), seriousness, and stratified by vaccine brand. The rate of self-reported adverse reaction was calculated after dose 1 and prior to dose 2 among all subjects who responded with at least one questionnaire. Results: 117,791 participants were included and responded to the first questionnaires after baseline: 88,196 from Germany, 27,588 from the Netherlands, 984 from France, 570 from Italy, 326 from Croatia, 89 from the United Kingdom and 38 from Belgium. 89,377 respondents received AstraZeneca, 14,658 BioNTech/Pfizer, 11,266 Moderna and 2490 Janssen. Reporting included all vaccine brands from all coun- tries, except Germany which only included data on Moderna until May 2021 and AstraZeneca until September 2021. Median time to completion was 8 days for the first questionnaire after dose 1 (Netherlands, Belgium, Italy, France, United Kingdom) and 3 days in Croatia. Median age category was 40-49 for all vaccine exposed groups except for BioNtech/Pfizer where median age was 70-79. Fatigue and headache were the most commonly reported solicited systemic adverse reactions, injection site reactions the most common solicited local reaction. AESIs were very rare (< 0.1%) and serious adverse reactions were uncommon (< 1%) across all vaccine brands. Conclusion: This study that collated self-reported data from more than 100,000 COVID-19 vaccine recipients, demonstrated feasibility of setting up and conducting cohort event monitoring across multiple European countries to collect safety data on novel vaccines that are rolled out at scale in populations which may not have been included in pivotal trials. Different vaccination schedules in countries and dif- ferent web applications resulted in some heterogeneity. The study confirmed the safety information in the product labels: reactogenic reactions, related to immunogenic response, and local injection site reactions were very common across all vaccines, whereas serious reactions or AESIs were (very) rare.