The Department of Health answers questions from The Detail

Q: Is the department aware of the number of adverse reactions reported by people/medical professionals in Northern Ireland to vaccinations and the seriousness of some of the side effects reported?

A: Within the UK, the national monitoring of the adverse effects of medicines is carried out by the MHRA, and this internationally recognised body gathers data from a wide variety of sources in order to perform its pharmacovigilance function e.g.; clinical and epidemiological studies worldwide published medical literature pharmaceutical companies worldwide regulatory authorities morbidity and mortality databases and spontaneous adverse drug reaction (ADR) reporting schemes, for example the yellow card scheme

Allied to the collection and evaluation of safety data, advice emanating from this work is cascaded throughout the UK. DHSSPS regularly cascades such safety information to the Service including those cases where medicines are being withdrawn from the market for safety reasons.

The department is aware that from time to time adverse reactions to medicines, including vaccines, will occur. As reactions can cover a wide range of symptoms of varying severity, reporting the total number of adverse reactions in Northern Ireland, or indeed any particular sub-region of the UK, would, in itself, not be particularly useful.

Q: The Freedom of Information response states that the department “is not routinely provided with Yellow Card statistics, or case reports, that originated from Northern Ireland.” Does this concern the Minister? Has he ever asked for these figures?

A: The Department does not routinely receive compilations of adverse reactions submitted to MHRA. The purpose of the MHRA pharmacovigilance scheme is post-marketing surveillance of medicines, on a UK wide basis, by way of identifying any causal relationship between a medicine and reported adverse reactions. The larger the population and numbers of reports the greater assurance of the integrity of any analysis. The data received by MHRA is also considered with comparative international data (see above) so that medicines which are available worldwide can continued to be assured of their quality and safety.

As reactions can cover a range of symptoms of varying severity, reporting the total number of adverse reactions, in itself, is not particularly useful. Because of the relatively small number of events, particularly serious events, it would be misleading and statistically incorrect to consider the number of reports from Northern Ireland in isolation. That is why adverse events must be assessed and monitored at a national level. Reports on safety of medicines and vaccines are publicly available on the MHRA website for all to see.

Q: Does this mean that the department never discusses reactions, investigates causes or acts on them?

A: The appropriate mechanism for investigating adverse reactions to a medicine or vaccine is through the MHRA yellow card system. Allied to the collection and evaluation of safety data by MHRA, advice emanating from this work is cascaded throughout the UK. DHSSPS regularly cascades such safety information to the Service including those cases where medicines are being withdrawn from the market for safety reasons.

Q: Is the department aware of a death reported to the MHRA in 2010 following a swine flu vaccine? Is this a concern for the department?

A: This answer has already been provided in the earlier FOI request.

Q: Can the department reassure the public that vaccinations offered to children and adults in Northern Ireland are safe?

A: All medicines have a unique profile of potential adverse effects ranging from minor to serious, from common to rare, taking account of the specific vulnerabilities of patients (e.g. renal insufficiency). These are documented in the Specific Product Characteristics (SPC) monographs which are regularly updated as new knowledge becomes available.

All medicines carry risks , but the Department can assure the public that very robust regulatory processes are applied before a medicine can be placed on the market, and also that the benefits associated with the immunisation programme are based on evidence that the benefits outweigh the potential risks.

Q: Are the benefits of mass vaccination programmes protecting thousands against serious diseases worth the risk of a small number of reactions?

A: Absolutely. Vaccines are not given lightly and the benefits of vaccine in preventing serious disease far outweigh the risks of any side effects. Vaccination programmes are based on advice from the Joint Committee on Vaccination and Immunisation and the vaccination programmes in Northern Ireland are the same as those across the rest of the UK. The MHRA continually monitors adverse effects of medicines, including vaccines, through the well established yellow card system.

The MHRA will alert the health service, department and a wide range of relevant organisations should any concern arise. The information gathered on adverse reactions is used to guide practitioners in how they prescribe and administer drugs in order to minimise adverse reactions, particularly those of severe nature, and in addition alert or warn the pharmaceutical industry so that improvements in drug development and production can be made.