COVID-19 Vaccines and Heavy Menstrual Bleeding: The Impact of Media Attention on Reporting to EudraVigilance.

BACKGROUND AND OBJECTIVE: During the COVID-19 vaccination campaign, over 34,000 reports of heavy menstrual bleeding following the administration of COVID-19 vaccines originating in the Economic European Area were submitted to EudraVigilance, the European Union database of suspected adverse drug reactions. More than 90% of these reports were sent by consumers while the remaining by healthcare professionals. Public concerns regarding menstruation disorders in COVID-19 vaccinees were also covered by the media. We investigated the impact of media attention on the reporting trends of heavy menstrual bleeding to EudraVigilance. METHODS: We used media outlets published in the Economic European Area on menstrual disorders and COVID-19 vaccines from the beginning of the vaccination campaign in the Economic European Area (1 January, 2021) until December 2022 (i.e., after the regulatory request to add the adverse event to the product information) and spontaneous reports from EudraVigilance. RESULTS: We found that the publication of safety updates from regulatory authorities and subsequent coverage in media outlets preceded increased reporting to EudraVigilance. Furthermore, the heavy menstrual bleeding reported in the cases occurred several weeks or months earlier and were not submitted to the respective date. The analysis suggests that the spikes in reporting of heavy menstrual bleeding were to some extent influenced by media coverage in some countries. CONCLUSIONS: Consumer reporting to the European Union spontaneous data collection system, EudraVigilance, was of high value for regulatory safety reviews, albeit the reporting behaviours were not free of the influence of the media. These sources of information can be investigated to understand the context of safety concerns of public health interest.

The Role of the European Medicines Agency in the Safety Monitoring of COVID-19 Vaccines and Future Directions in Enhancing Vaccine Safety Globally.

The European Union (EU) regulatory network was at the forefront of the safety monitoring of COVID-19 vaccines during the pandemic. An unprecedented number of case reports of suspected adverse reactions after vaccination called for huge efforts for the assessment of this safety information, to ensure that any possible risks were detected and managed as early as possible, while ruling out coincidental but temporally related adverse health outcomes. We describe the role of the European Medicines Agency alongside the EU regulatory network in the safety monitoring of the COVID-19 vaccines, and provide an insight into challenges, particularities and outcomes of the scientific assessment and regulatory decisions in the complex, dynamic international environment of the pandemic. We discuss the flexible procedural tools that were used to ensure an expedited scientific assessment of safety issues, and subsequent updates of the product information (i.e., labelling) when available evidence (e.g., spontaneous reports, findings from observational studies and/or scientific literature) suggested that causal association is at least a reasonable possibility. The safety monitoring was accompanied by enhanced transparency measures, proactive communication, and easy access to information, which played a key role in public reassurance. The pandemic has been a powerful booster for worldwide collaboration, exchange of information and work-sharing. The safety monitoring of COVID-19 vaccines continues, and the lessons learned will be applied in future safety reviews, as well as future health emergencies.

Safety monitoring of Influenza A/H1N1 pandemic vaccines in EudraVigilance.

The 14,543 spontaneous reports of suspected adverse reactions received in EudraVigilance from 1 November 2009 to 30 April 2010 for three centrally authorized Influenza A/H1N1 vaccines marketed in the European Economic Area (Celvapan, Focetria and Pandemrix) were extracted to evaluate the effectiveness of recommendations to strengthen pharmacovigilance systems during the pandemic and illustrate methods of signal detection used by the European Medicines Agency in this context. The number of vaccinees on 30 April 2010 was estimated to be at least 37,166,000 with a reporting rate of 391 per million vaccinees. 81.4% of reports were received in a period of 2 months ending 31 December 2009. Reports for A/H1N1 vaccines had fewer missing values for date of birth, age, case narrative, vaccination date and reaction onset date than reports involving human papilloma virus vaccines in a pre-pandemic period but more missing batch numbers (46.6%), with earlier notification by health care professionals to national authorities (median of 7 days since reaction onset date) and by national authorities to EudraVigilance (4 days). The network of European pharmacovigilance centers and the Agency was effective for monitoring the safety of A/H1N1 vaccines during the 2009-2010 influenza pandemic and coped with a sudden increase of the number of reports. Areas to be reinforced in order to improve the response to a future pandemic and to strengthen vaccine pharmacovigilance systems in general are highlighted. Observed-to-expected analyses were affected by uncertainties regarding the numbers of vaccinated individuals and age-specific background incidence rates. Imbalance analysis used by the Agency may overcome some of these limitations but needs further development. A multinational vaccine health outcome resource is needed to assess the burden of vaccine preventable diseases and the epidemiology of potential adverse outcomes, and to quickly evaluate safety signals, estimate the utilization, benefits and risks of vaccines and evaluate the effectiveness of public health measures.