Moji razgovori s Emom, drugi dio: Vaccine side effects monitoring system
Greetings,
following our prior discussion I would like to ask you some more question.
I am interested in vaccine side effects monitoring system.
1. How does the side effects monitoring system work?
2. Is it a harmonised standard or every members state has its own standard?
3. How many side effects have been detected so far in the EU for each vaccine?
4. How many deaths if any related to the vaccines have been reported?
5. What is the relation of reported number of side effects and the unreported number of side effects?
Thank you.
Fri, Jul 16, 2021, 9:10 AM
Dear Mr Sinčić,
Thank you very much for your email to Ms Boone, who asked me to reply to you.
Please find below some answers (marked in blue font), including links to selected EMA webpages which may be of particular interest to you.
Should you have any further questions please not hesitate to contact us again.
Kind regards
Riccardo Mezzasalma
Institutional Liaison Officer
Jul 19, 2021, 9:40 AM
Greetings,
following our prior discussion I would like to ask you some more question.
I am interested in vaccine side effects monitoring system.
1. How does the side effects monitoring system work?
In the EU, suspected side effects on medicines (including vaccines) can be reported by patients and healthcare professionals (i.e. doctors, nurses or pharmacists), pharmaceutical companies and companies importing or distributing medicines and national competent authorities for medicines. The reporting of side effects is normally carried out by healthcare professionals, who then pass them on to regulators. Patients are also able to report suspected side effects directly through various methods such as online patient reporting forms hosted by national medicines regulatory authorities or by telephone (e.g. contacting the manufacturer of the medicine using the instructions in the package leaflet). See for more details: Reporting suspected side effects
The company that holds the marketing authorisation for a medicine has legal obligations to continuously collect data and conduct safety monitoring (also known as ‘pharmacovigilance’) activities. Data has to be transmitted to the authorities within defined timelines (periodic safety update reports, or PSURs), and any emerging concern about the benefit-risk balance has to be notified immediately. If necessary, the authorities may request further investigations.
The EMA is responsible for developing and maintaining EudraVigilance, a system for managing and analysing information on suspected adverse reactions to medicines authorised in the European Economic Area (EEA). EudraVigilance is a single repository for reports of suspected adverse reactions seen in healthcare practice and clinical trials. It is used by Member states, the Agency and industry. EMA publishes data from EudraVigilance in the European database of suspected adverse drug reaction reports.
The EudraVigilance database is also an important source of information on safety signals. A safety signal is information on a new or known adverse event that may be caused by a medicine and requires further investigation. Safety signals can be detected from a wide range of sources, such as spontaneous reports, clinical studies and scientific literature. The presence of a safety signal does not directly mean that a medicine has caused the reported adverse event. An illness or another medicine taken by the patient could also be the cause. The assessment of safety signals establishes whether or not there is a causal relationship between the medicine and the reported adverse event.
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) evaluates safety signals and may recommend regulatory action as a result. EMA’s detailed assessments take into account all available data from all sources to draw a robust conclusion on the safety of the medicine. These data include clinical trial results, reports of suspected side effects in EudraVigilance, epidemiological studies monitoring the safety of the vaccine, toxicological investigations and any other relevant information. Various official procedures exist for updating product information and implementing other safety measures, with varying degrees of urgency.
More information on the pharmacovigilance activities in the EU can be found on the EMA website at: Pharmacovigilance: Overview | European Medicines Agency (europa.eu)
2. Is it a harmonised standard or every members state has its own standard?
The system is harmonised. MSs have their own reporting procedures translated in national languages, but the standards are the same across the EU/EEA. The legal framework of pharmacovigilance for medicines marketed within the EU is provided for in Regulation (EC) No 726/2004 with respect to EU authorised medicinal products and in Directive 2001/83/EC with respect to nationally authorised medicinal products (including those authorised through the mutual recognition and decentralised systems).
EU law requires each marketing authorisation holder, national competent authority and EMA to operate a pharmacovigilance system. The overall EU pharmacovigilance system operates through cooperation between the EU Member States, EMA and the European Commission. In some Member States, regional centres are in place under the coordination of the national competent authority. The EU has a comprehensive safety monitoring and risk management (pharmacovigilance) system, which ensures standard procedures and good pharmacovigilance practices (GVP) are in place for:
-providing advice to minimise risk;
-reporting suspected side effects;
-conducting studies after authorisation;
-detecting any potential side effects;
-conducting rigorous scientific assessments of all safety data;
-introducing any necessary mitigating actions early on.
For COVID-19 medicines, the existing pharmacovigilance (GVP) standards apply and additional monitoring activities have been introduced. This comprises new reporting obligations for companies that will have to submit monthly safety reporting summaries to EMA, in addition to the regular updates foreseen by the legislation, and exceptional transparency measures set up by EMA. See for more details: Pharmacovigilance plan for COVID-19 vaccines and at Monitoring vaccine safety and use in real life (for COVID-19).
3. How many side effects have been detected so far in the EU for each vaccine?
Since January 2021 EMA publishes safety updates for the COVID-19 vaccines authorised in the EU. The safety updates summarise the data that have become available since the vaccine’s authorisation. They also indicate whether any safety information requires further investigation. Detailed information on this is available at: Safety updates for authorised COVID-19 vaccines
4. How many deaths if any related to the vaccines have been reported?
Updated data on cases of suspected side effects spontaneously reported to EudraVigilance from EU/EEA countries, including cases which reported a fatal outcome, are included in the link in the previous answer above, broken down for each COVID-19 vaccine authorised in the EU. NOTE: These reports describe suspected side effects in individuals, i.e. medical events observed following the use of a vaccine. The fact that someone has had a medical issue or died after vaccination does not necessarily mean that this was caused by the vaccine. This may have been caused, for example, by health problems not related to the vaccination.
5. What is the relation of reported number of side effects and the unreported number of side effects?
This ratio is unknown. The majority of spontaneous reports continue to be submitted by healthcare professionals. However, the campaigns by the regulatory network to facilitate and encourage direct reporting by patients have continued in many Member States, including regular EU-wide campaigns. As a result patient reporting in the EEA has increased from around 30,000 individual case safety reports (ICSR) for serious adverse effects in 2014 to over 50,000 in 2018 (source: Report on pharmacovigilance tasks from EU Member States and the European Medicines Agency (EMA), 2015-2018).
It also has to be noted that spontaneous reporting of suspected adverse drug reactions is only one of the many sources used by EMA and national competent authorities to monitor the safety of medicines. Other sources include medical literature monitoring, periodic safety update reports (PSURs), risk management plans and signal management. Please refer to our answer to the first question above and the link to the EMA’s Pharmacovigilance page for more information.
Thank you.
Jul 19, 2021, 9:40 AM
