The Medicines and Healthcare products Regulatory Agency (MHRA) has in place a proactive safety monitoring strategy for the swine influenza vaccines currently in use in the United Kingdom. As part of this, the MHRA established a dedicated reporting system, an adjunct to the existing Yellow Card scheme, for suspected side effects to the vaccines.
The strategy involves daily analysis of all suspected side effect reports, a real-time statistical analysis of the data and weekly publication of its ongoing review on the MHRA website:
www.mhra.gov.uk/swineflu
As well as such data arising from the UK reporting scheme, the MHRA has been fully involved in evaluating similar safety data from across Europe, as well as emerging safety data from ongoing clinical studies.
The MHRA’s analysis has so far found that the number and the nature of suspected side effects reported to date accord with expectations. The most frequently reported suspected side effects are injection site reactions (such as pain, swelling, redness), or are well known and common side effects of many vaccines, including the swine flu vaccines (such as nausea, vomiting, dizziness, muscle pain, fever, fatigue, headaches, swollen glands). These are generally mild and short-lasting.
No unexpected or serious new safety issues have been identified from UK and non-UK safety data received to date. The balance of benefits and risks for swine flu vaccines used in the UK remains positive. As with all medicines and vaccines on the UK market, the MHRA will keep the safety of swine flu vaccines under close review.