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 (HPRA) and the European Medicines Agency (EMA). These agencies have strict procedures for the licensing and monitoring of all vaccines to ensure their safety and effectiveness.By July 2016, over 205 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 660,000 doses of Gardasil® have been administered and more than 200,000 girls have been fully vaccinated against HPV.
All national and international regulatory bodies have stated HPV vaccines are safe.
The Centers for Disease Control and Prevention, US, state HPV vaccination is recommended because the benefit of, preventing cancer, far outweigh the risks of possible side effects.
In May 2016 the UK Medicines and Healthcare Regulatory Agency reported :
“More than three million girls have been vaccinated so far in the UK with HPV vaccine, and tens of millions more have been vaccinated globally. As with all vaccines, safety remains under continual review, and HPV vaccine has a very good safety record”.
In April 2016 the American Society of Clinical Oncology, the world leading Medical Professional Oncology society “implored” the health care provider community in countries to increase HPV vaccination, to lessen the burden of cancer that women suffer. The American Society of Clinical Oncology stated the vaccines have a strong safetyrecord and the ability to prevent new cancer from HPV genotype-specific infections.
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 at http://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 HPV vaccines including Gardasil vaccine.
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
The Centers for Disease Control and Prevention, US, which monitors vaccine safety in the US, has monitored the safety of the HPV vaccine for over ten years, provides an information leaflet for parents on the safety of Gardasil vaccine, updated in April 2016, available at http://www.cdc.gov/vaccinesafety/pdf/data-summary-hpv-gardasil-vaccine-is-safe.pdf and further information at http://www.cdc.gov/vaccinesafety/vaccines/hpv/hpv-safety-faqs.html
In January 2017 all 69 US National Cancer Institute NCI-designated Cancer Centers Endorsed HPV Vaccination
“As national leaders in cancer research and clinical care, we are compelled to collectively call upon parents and health care providers to increase vaccination rates so our nation’s children don’t grow up to become cancer patients.
HPV vaccines, like all vaccines (used in the U.S.), have passed extensive safety testing before and after being approved.
The vaccines have a safety profile similar to that of other vaccines approved for adolescents in the U.S.
Internationally, the safety of HPV vaccines has been tested and approved by the World Health Organization’s Global Advisory Committee on Vaccine Safety”.
See information at https://www.ucdmc.ucdavis.edu/news/images/pdf/HPVConsensusStatement_Jan2017.pdf
HPV Vaccine safety and Effectiveness
Since HPV vaccine was licensed in 2006 research has been conducted all over the world that demonstrates that the vaccine is safe and prevents cancer. The evidence has been steadily growing since 2006 and now a large bank of research exists which proves the safety and effectiveness of this vaccine. This heat map shows the countries which have conducted most research on HPV vaccine however, studies have been conducted worldwide which confirm that HPV vaccination is the right way to protect girls from cervical cancer.
Click here to read more about the research.
This page was updated on 10 January 2017