Drug safety · 2025
Implementation and Results of Active Vaccine Safety Monitoring During the COVID-19 Pandemic in the UK: A Regulatory Perspective.
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Wong Jenny, Donegan Katherine, Harrison Kendal, Jan Tahira, Cave Alison, Tregunno Phil
Аннотация
INTRODUCTION: Yellow Card Vaccine Monitor (YCVM) was established by the UK Medicines and Healthcare products Regulatory Agency (MHRA) to facilitate active monitoring of adverse drug reactions following COVID-19 vaccination and further characterise safety in populations under-represented in clinical trials.
OBJECTIVE: This study explored the profile of individuals registered to the YCVM platform and the suspected adverse drug reactions reported following a COVID-19 vaccination on this data platform.
METHODS: Using a stratified random selection approach, individuals were invited to register and actively contacted to seek further information on the vaccines received and adverse reactions they experienced. Exploratory analyses were conducted to characterise the demographics of individuals registered in the YCVM, and to summarise the adverse drug reaction data reported by recruited individuals between November 2020 and December 2022. Detailed analyses of the sub-cohort of pregnant and breastfeeding females were conducted to characterise these individuals. Data for two suspected adverse reactions, menstrual disorders and tinnitus, were extracted and analysed to demonstrate how YCVM supported regulatory assessment of these safety signals which originally arose from other data sources.
RESULTS: 36,604 individuals registered, with 30,281 reporting vaccination. Median (interquartile range) follow-up was 184 days (14-367). Demographics of the recruited cohort reflected the vaccinated population and timing of invitations. 15,764 (52.1%) of those reporting vaccination reported experiencing at least one adverse reaction. However, nearly all were expected acute reactions and 4134 (13.7%) reported an event considered medically serious. The data raised no safety concerns in pregnant and breastfeeding females. Reporting of menstrual disorders appeared stimulated by media interest, as seen in spontaneous reporting systems. Data on the incidence of tinnitus were used to support regulatory action on this signal.
CONCLUSION: Active surveillance using the YCVM provided a complementary data source for monitoring the safety of COVID-19 vaccines. However, further efforts are needed to recruit ethnic minorities. The technology developed has enhanced regulatory vigilance options and could be valuable in the future for actively monitoring the safety of innovative products used in small populations.
OBJECTIVE: This study explored the profile of individuals registered to the YCVM platform and the suspected adverse drug reactions reported following a COVID-19 vaccination on this data platform.
METHODS: Using a stratified random selection approach, individuals were invited to register and actively contacted to seek further information on the vaccines received and adverse reactions they experienced. Exploratory analyses were conducted to characterise the demographics of individuals registered in the YCVM, and to summarise the adverse drug reaction data reported by recruited individuals between November 2020 and December 2022. Detailed analyses of the sub-cohort of pregnant and breastfeeding females were conducted to characterise these individuals. Data for two suspected adverse reactions, menstrual disorders and tinnitus, were extracted and analysed to demonstrate how YCVM supported regulatory assessment of these safety signals which originally arose from other data sources.
RESULTS: 36,604 individuals registered, with 30,281 reporting vaccination. Median (interquartile range) follow-up was 184 days (14-367). Demographics of the recruited cohort reflected the vaccinated population and timing of invitations. 15,764 (52.1%) of those reporting vaccination reported experiencing at least one adverse reaction. However, nearly all were expected acute reactions and 4134 (13.7%) reported an event considered medically serious. The data raised no safety concerns in pregnant and breastfeeding females. Reporting of menstrual disorders appeared stimulated by media interest, as seen in spontaneous reporting systems. Data on the incidence of tinnitus were used to support regulatory action on this signal.
CONCLUSION: Active surveillance using the YCVM provided a complementary data source for monitoring the safety of COVID-19 vaccines. However, further efforts are needed to recruit ethnic minorities. The technology developed has enhanced regulatory vigilance options and could be valuable in the future for actively monitoring the safety of innovative products used in small populations.