Eugene Murphy
Question:449. Deputy Eugene Murphy asked the Minister for Health his views on the selection of persons for the trial of vaccines (details supplied). [6049/18]
View answerTuesday, 6 February 2018
Questions (449)
Written answers
The efficacy of a vaccine for a specific disease is usually defined as the reduction in the chance of developing the disease after vaccination relative to the chance when unvaccinated, as determined in a prospective randomised controlled trial. Clinical trials submitted in an application for a marketing authorisation to place a medicine on the market are reviewed, including the trial methodology, how biases were controlled, and all aspects of vaccine safety, including allergic reactions. Once the efficacy, safety and quality has been reviewed and the vaccine is considered to have a positive benefit-to-risk balance, it is then authorised. The authorised product information provides information on the safe use of the vaccine, and specifically contraindicates the use of the vaccine in patients with known hypersensitivity to the active substances or other inert ingredients.
Vaccines may be given in accordance with official recommendations but they are never mandated, and the contraindications and warnings outlined in the product information are taken into account prior to administration to a specific patient; for example, hypersensitivity or a patient’s immune status. Vaccines on the market are continuously monitored and this will provide additional safety data on less frequent and rare adverse events. Additionally, ongoing safety studies from the medical literature are reviewed and further changes to the product information may be proposed or, if necessary, a reassessment of its benefit/risk is performed.
In summary, a vaccine is rigorously tested in clinical trials before being authorised for use, and regularly reviewed once it is on the market.
Question No. 450 answered with Question No. 448.