HPV Vaccine Safety Review

How do we know that the Gardasil® vaccine is safe?

The HSE is guided by the recommendations of the National Immunisation Advisory Committee (NIAC) and the World Health Organization (WHO).

All vaccines used by the HSE including Gardasil® are licensed by the Health Products Regulatory Authority and the European Medicines Agency. These agencies have strict procedures for the licensing and monitoring of all vaccines to ensure their safety and effectiveness.

By January 2016, over 200 million doses of Gardasil® have been distributed worldwide, either as part of national immunisation programmes or by private doctors. Gardasil® is currently used in over 25 European countries, the United States, Canada, Australia and New Zealand.

In Ireland 580,000 doses of Gardasil® have been administered and over 200,000 girls have been fully vaccinated against HPV.

The World Health Organization Global Advisory Committee for Vaccine Safety (GACVS) has reviewed the evidence on the safety of Gardasil vaccine. The WHO concluded in December 2015 that Gardasil continues to have an excellent safety profile. Further information can be found here.http://www.who.int/vaccine_safety/committee/GACVS_HPV_statement_17Dec2015.pdf

In November 2015 the European Medicines Agency (EMA) reported on a review of HPV vaccines. This report found no evidence the vaccine was linked to chronic fatigue like conditions. On January 12 2016 the EMA issued a final report on this review of HPV vaccines: “EMA confirms evidence does not support that they cause CRPS or POTS”  Please see link for full details athttp://www.ema.europa.eu/docs/en_GB/document_library/Referrals_document/HPV_vaccines_20/European_Commission_final_decision/WC500196773.pdf

In January 2016, the European Commission endorsed the conclusion of the EMA, that there is no need to change the summary of product characteristics for Gardasil vaccine.

The Center for Disease Control and Prevention, US, provides an information leaflet for parents on the safety of Gardasil vaccine. http://www.cdc.gov/vaccinesafety/pdf/data-summary-hpv-gardasil-vaccine-is-safe.pdf 


This page was updated on 06/07/2016