HPV vaccine safety and effectiveness

HPV Vaccine Safety and Effectiveness 2006 - 2018

Since HPV vaccine was licensed in 2006 research has been conducted all over the world that demonstrates that the vaccine is safe and prevents pre cancers. 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 below 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. The vaccine is now offered by health authorities in more than 84 countries worldwide to prevent cancer caused by the HPV virus.

Click here to download a copy of the research listed below

HPVgraphic

2018

June

Research published from England shows that 8 years after the introduction of HPV vaccine cancer causing HPV infections have fallen 86% among women aged 16 to 21 who were eligible for the vaccine.

“The Impact of the National HPV Vaccination Program in England Using the Bivalent HPV Vaccine: Surveillance of Type-Specific HPV in Young Females, 2010–2016”

David Mesher, Kavita Panwar, Sara L Thomas, Claire Edmundson, Yoon Hong Choi, Simon Beddows Kate Soldan

The Journal of Infectious Diseases, jiy249, https://doi.org/10.1093/infdis/jiy249

May 

A study published  in the Canadian Medical Association Journal  shows no increased risk of autoimmune disorders in girls who received quadrivalent human papillomavirus (HPV4) vaccination, adding to the body of evidence for the safety of GARDASIL vaccine

“Quadrivalent human papillomavirus vaccination in girls and the risk of autoimmune disorders: the Ontario Grade 8 HPV Vaccine Cohort Study”

Erin Y. Liu, Leah M. Smith, Anne K. Ellis, Heather Whitaker, Barbara Law, Jeffrey C. Kwong, Paddy Farrington and Linda E. Lévesque

CMAJ May 28, 2018 190 (21) E648-E655; DOI: https://doi.org/10.1503/cmaj.170871

Evidence published in the  Cochrane Library shows that human papilloma virus (HPV) vaccines protect against cervical lesions in young women.

The evidence also shows the risk of serious adverse events is similar between control and HPV vaccines in women of all ages

Prophylactic vaccination against human papillomaviruses to prevent cervical cancer and its precursors

Marc Arbyn, Lan Xu, Cindy Simeons, Pierre PL Martin Hirsch

Cochrane Library:  http://cochranelibrary-wiley.com/doi/10.1002/14651858.CD009069.pub3/abstract

February

This study, reporting the longest surveillance follow-up to date, shows the HPV infection rate among women aged 18 to 24 dropped from 22.7% to 1.1% between 2005 and 2015. A substantial fall also occurred in women aged 25–35, despite lower vaccine coverage. Very Low Prevalence of Vaccine Human Papillomavirus Types Among 18- to 35-Year Old Australian Women 9 Years Following Implementation of Vaccination

Dorothy A Machalek, Suzanne M Garland, Julia M L Brotherton, Deborah Bateson, Kathleen McNamee, Mary Stewart, S Rachel Skinner, Bette Liu, Alyssa M Cornall , John M Kaldor, Sepehr N Tabrizi

The Journal of Infectious Diseases, jiy075, https://doi.org/10.1093/infdis/jiy075 

January

11 years after HPV vaccine introduction, study shows significant decreases in vaccine-type HPV in vaccinated women. The decrease in 4-valent vaccine-type HPV indicates Gardasil vaccine effectiveness.

9-Valent and 4-Valent HPV Vaccine Effectiveness and Herd Protection among Young Women, 11 Years after Vaccine Introduction

Spinner Chelse, Lili Ding, David Bernstein, Darron R. Brown, Eduardo L.Franco, Jessica A. Kahn,

https://www.sciencedirect.com/science/article/pii/S1054139X17307012

2017

December

World Health Organization released an information sheet – Observed rate of vaccine reactions human papilloma virus vaccine

http://www.who.int/vaccine_safety/initiative/tools/HPV_vaccine_rates_information_sheet_1217.pdf?ua=1 

There is a large volume of evidence on the safety of the human papillomavirus (HPV) vaccine. This paper has identified robust scientific evidence that supports the safety of the HPV vaccine.

Safety of Human Papillomavirus Vaccines: An Updated Review

Anastasia Phillips, Cyra Patel, Alexis Pillsbury, Julia Brotherton, Kristine Macartney

Drug Saf https://doi.org/10.1007/s40264-017-0625-z

November

4-Valent Human Papillomavirus (4vHPV) Vaccine in Preadolescents and Adolescents After 10 Years

Daron G. Ferris, Rudiwilai Samakoses, Stanley L. Block, Eduardo Lazcano-Ponce, Jaime Alberto Restrepo, Jesper Mehlsen, Archana Chatterjee, Ole-Erik Iversen, Amita Joshi, Jian-Li Chu, Andrea Likos Krick, Alfred Saah, Rituparna Das

http://pediatrics.aappublications.org/content/early/2017/11/20/peds.2016-3947

October

Another published study shows no evidence that the HPV vaccine increases risk of autoimmune and neurological diseases in adult women aged 18-44 years.

Human papillomavirus vaccination of adult women and risk of autoimmune and neurological diseases

Hviid, A, Svanström, H, Scheller, N. M., Grönlund, O., Pasternak, B., Arnheim-Dahlström, L.

Journal of Internal Medicine, 1365-2796, UR - http://onlinelibrary.wiley.com/doi/10.1111/joim.12694/full

A study following 2084 women in Denmark, Iceland, Norway, and Sweden shows that the HPV vaccine provides continued protection in women for at least 10 years, with a trend for continued protection through 12 years of follow-up.

A 12-Year Follow-up on the Long-Term Effectiveness of the Quadrivalent Human Papillomavirus Vaccine in 4 Nordic Countries

Susanne K Kjaer Mari Nygård Joakim Dillner J Brooke Marshall David Radley Meng Li Christian Munk Bo T Hansen Lara G Sigurdardottir Maria Hortlund.

Clinical Infectious Diseases, cix797, https://doi.org/10.1093/cid/cix797

July

The World Health Organisation (WHO) has again reported in July 2017 that HPV vaccines are considered to be extremely safe. The World Health Organization (WHO) Global Advisory Committee for Vaccine Safety (GACVS) has reviewed the evidence on the safety of Gardasil vaccine in 2007, 2008, 2009, 2013, 2014 and 2015. WHO has never reported safety concerns with HPV vaccines.

WHO Safety Update of HPV vaccines

http://www.who.int/vaccine_safety/committee/topics/hpv/en/

 

A large Norwegian study aimed to ascertain if any association existed between HPV vaccination and chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME). Over 176,000 girls who were eligible for HPV vaccination were included in the study. No indication of increased risk of CFS/ME following HPV vaccination was observed among girls who were vaccinated.

Feiring B, Laake I et al. HPV vaccination and risk of chronic fatigue syndrome/myalgic encephalomyelitis: A nationwide register-based study from Norway.  HPV vaccination and risk of chronic fatigue syndrome/myalgic encephalomyelitis: A nationwide register-based study from Norway. Vaccine Volume 35, Issue 33, , Pages 4203-4212

http://www.sciencedirect.com/science/article/pii/S0264410X17308083

 

In Scotland research has shown there has been a 90% fall in HPV infections in vaccinated girls which is even better than expected. In Scotland 90% of girls have accepted HPV vaccination. 

Scottish Microbiological Society https://www.microbiologysociety.org/news/hpv-immunisation-campaign-causes-massive-reduction-in-prevalence-of-cancer-causing-virus-in-scottish-women.html

 

June

A British study based upon two large population-based probability sample surveys found that fewer women, aged 18 to 20 years who were vaccinated  against HPV 16/18 tested positive for HPV 16/18 (5.8% versus 11.2% in those unvaccinated).

Tanton C, Mesher D et al  Human papillomavirus (HPV) in young women in Britain: Population-based evidence of the effectiveness of the bivalent immunisation programme and burden of quadrivalent and 9-valent vaccine types. Papillomavirus Res. 2017 Jun;3:36-41

https://www.ncbi.nlm.nih.gov/pubmed/28626810

 

May

The World Health Organization updated their position statement on HPV vaccines. They state that adverse events following HPV vaccination are generally non-serious and of short duration. Data from all sources continue to be reassuring regarding the safety profile of all 3 HPV vaccines in use. Concerns have been raised about complex regional pain syndrome (CRPS) and postural orthostatic tachycardia syndrome (POTS) following HPV vaccination. Despite the difficulties in diagnosing both disorders, reviews of pre- and post-licensure data have provided no evidence that these syndromes are a direct effect of the HPV vaccines. The WHO Global Advisory Committee for Vaccine Safety has stated that policy decisions based on weak evidence, leading to lack of use of safe and effective vaccines, can result in significant harm.

 

Human papillomavirus vaccines: WHO position paper, May 2017 http://apps.who.int/iris/bitstream/10665/255353/1/WER9219.pdf?ua=1

 

March

An English study examined girls aged 11 to 20 years who were admitted to hospital with Guillain-Barre syndrome. The study found no evidence of an increased risk of GBS in the first 3, 6 or 12 months following a dose of HPV vaccination.

 

Andrews N, Stowe J, Miller ENo increased risk of Guillain-Barre syndrome after human papilloma virus vaccine: A self-controlled case-series study in England Vaccine. 2017 Mar 23;35(13):1729-1732.

https://www.ncbi.nlm.nih.gov/pubmed/28245941

 

A French based study of over 3,700 sexually active young women found that  the prevalence of HPV strains contained in vaccines  (vaccine type HPV prevalence) was significantly lower among confirmed vaccinated women than among those women who were unvaccinated. This study showed the effectiveness of HPV prophylactic vaccines at an individual level.

 

Heard I, Tondeur L Effectiveness of Human Papillomavirus Vaccination on Prevalence of Vaccine Genotypes in Young Sexually Active Women in France  J Infect Dis. 2017 Mar 1;215(5):757-763.

https://www.ncbi.nlm.nih.gov/pubmed/28011911

 

February 

A French based follow-up study assessed if any association existed between HPV vaccine exposure and autoimmune diseases in French adolescents and young adults in the first 6 and a half years of vaccination in France. They found that exposure to HPV vaccines was not associated with an increased risk of autoimmune diseases, specifically central demyelination/multiple sclerosis, connective tissue disease, type 1 diabetes, autoimmune thyroiditis or idiopathic thrombocytopenic purpura.

 

Grimaldi-Bensouda L, Rossignol M et al Risk of autoimmune diseases and human papilloma virus (HPV) vaccines: six years of case-referent surveillance

J Autoimmun. 2017 May;79:84-90. doi: 10.1016/j.jaut.2017.01.005. Epub 2017 Feb 9

https://www.ncbi.nlm.nih.gov/pubmed/28190705

 

2016 

December 2016

A study examined if any potential risk of new onset autoimmune disease in women aged 9 to 25 years in the United Kingdom after administration of the AS04-HPV 16/18 vaccine, existed. This found no evidence of an increased risk of autoimmune disease in women aged 9 to 25 years after vaccination.

 Willame C,  Rosillon D et a. Risk of new onset autoimmune disease in 9- to 25- year old women exposed to human papillomavirus – 16/18 AS04-adjuvanted vaccine in the United Kingdom

Hum Vaccin Immunother. 2016 Nov;12(11):2862-2871. Epub 2016 Jul 18 https://www.ncbi.nlm.nih.gov/pubmed/27428517

 

A US study examined a group of sexually active, inner-city adolescent women receiving the 3-dose quadrivalent vaccine. Compared to unvaccinated women, those who were vaccinated had significantly lower incidence of cervical infection with HPV6/11/16/18. Among adolescents immunized at 15 years of age or older, a longer time to complete the 3-dose schedule was associated with an increased risk of anogenital HPV6/11/16/18 infection and an increased incidence of associated cervical cytological abnormalities.

 

Schlecht N F,Diaz A et al. Risk of Delayed Human Papillomavirus Vaccination in Inner-City Adolescent Women The Journal of Infectious Diseases,  214. 12,1952–1960,

https://academic.oup.com/jid/article-abstract/214/12/1952/2194444

 

November 2016

A literature review focused upon 13 randomized controlled trials which compared HPV vaccines to controls. Of the 11,189 people in seven publications reporting cumulative, all-type adverse events, the vaccinated group was higher than the control group, although the most common adverse events were injection-sire reactions. There was no significant difference in systemic symptoms. The authors concluded with the finding that the vaccination was a safe preventative measure for both men and  women.

Mohamed Macki and Ali A. Dabaja  Literature review of vaccine-related adverse events reported from HPV vaccination in randomized controlled trials. Basic Clin Androl. 2016; 26: 16

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5116857/

 

October

CDC and American Advisory Committee on Immunization Practices recommend a two dose HPV vaccine and states this schedule would ensure more Americans are protected from cancer.

http://www.cdc.gov/media/releases/2016/p1020-hpv-shots.html

 

A large clinical trial recruited women from Europe, North and Latin Americas and the Asia Pacific region.  Women older than 25 years who were vaccinated with the HPV 16/18 vaccine were protected against infections, cytological cervical abnormalities and lesions associated with HPV 16/18 and cervical intraepithelial neoplasia as well as infection with non-vaccine types HPV 31 and 45 over a seven year period.

Wheeler Cosette M et al. Efficacy, safety and immunogenicity of the human papillomavirus 16/18 AS04-adjuvanted vaccine in women older than 25 years: 7-year follow-up of the phase3, double-blind, randomised controlled VIVIANE study The Lancet infectious Disease  Volume 16, No. 10, p1154–1168, October 2016

http://www.thelancet.com/journals/laninf/article/PIIS1473-3099(16)30120-7/abstract

 

September

Danish study finds that compared to controls, women reporting severe adverse reactions to HPV vaccine had increased care-seeking in the 2 years before receiving the first HPV vaccine.

Mølbak  K, Hansen NValentiner-Branth P.Pre-Vaccination Care-Seeking in Females Reporting Severe Adverse Reactions to HPV Vaccine. A Registry Based Case-Control Study. PLoS One. 2016 Sep 9;11(9):e0162520.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5017678/pdf/pone.0162520.pdf

 

August

CDC US Department of Health and Human Services, American Academy of Family Physicians, and American Academy of Pediatrics declare that Gardasil is safe. 

https://www.cdc.gov/vaccinesafety/pdf/data-summary-hpv-gardasil-vaccine-is-safe.pdf

  

Irish Cancer Society Decoding Cancer public talks entitled: ‘The HPV Vaccine – Warts and all’ were held in Galway on August 23rd and in Cork, August on 24th. The talks outlined the significance of HPV as a cause of cancer and the facts about the safety and effectiveness of the vaccine in cervical and other cancer prevention.

https://www.cancer.ie/events/decoding-cancer-hpv-vaccine-%E2%80%93-warts-and-all-galway

 

July

American Cancer Society updated its guideline for HPV vaccination to include males.

http://www.cancer.org/cancer/news/news/american-cancer-society-updates-hpv-vaccine-recommendations-to-include-males

 

Swedish study finds Gardasil vaccination was not associated with increased incidence of new-onset autoimmune disease in girls and women with pre-existing autoimmune disease. Gardasil vaccination was associated with a slightly reduced risk (0.77, 95% CI 0.65-0.93) of new onset autoimmune disease.

Grönlund OHerweijer ESundström KArnheim-Dahlström LIncidence of new-onset autoimmune disease in girls and women with pre-existing autoimmune disease after quadrivalent human papillomavirus vaccination: a cohort study.J Intern Med. 2016 Jul 31. [Epub ahead of print]

https://www.ncbi.nlm.nih.gov/labs/articles/27478093/

 

May

Australian review finds that implementation of HPV vaccination programmes resulted in reductions of HPV 6, 11,16 & 18 infection (90%), genital warts (90%), low-grade cytological cervical abnormalities (45%) and high-grade histologically proven cervical abnormalities (85%). Ensuring broad coverage of appropriate populations can provide a major advancement in global public health.

Garland S, Kjaer S, Munoz N et al. Impact and Effectiveness of the Quadrivalent Human Papillomavirus Vaccine: A Systematic Review of 10 Years of Real - world Experience - on the benefits of the HPV vaccine. Clinical Infectious Diseases, first published online May 26, 2016

http://cid.oxfordjournals.org/content/early/2016/06/14/cid.ciw354.full

 

Irish Cancer Society states that a combination of a HPV vaccination and cervical screening programme, has the potential to reduce the incidence of cervical cancers by 90%. The Society also states that the HPV Vaccine is safe and that there is no scientific evidence to suggest otherwise. 

https://www.cancer.ie/reduce-your-risk/healthy-lifestyle/europeancode/hpv-vaccine

 

April

American Society of Clinical Oncology strongly recommends the need to increase the proportion of adolescent boys and girls receiving the HPV vaccine which could lead to complete eradication of HPV-related cancers in men and women.

http://ascopubs.org/doi/pdf/10.1200/JCO.2016.67.2014

 

January

EMA concludes that there is zero evidence that HPV vaccines cause CRPS or POTS or chronic fatigue like conditions. They conclude that the benefits of HPV vaccines continue to outweigh their risks and that use of these vaccines is expected to prevent many cases of cervical cancer as well as various other cancers and conditions caused by HPV.

European Medicines Agency HPV vaccines: EMA confirms evidence does not support that they cause CRPS or POTS 12 January 2016

http://www.ema.europa.eu/ema/index.jsp%3Fcurl%3Dpages/medicines/human/referrals/Human_papillomavirus_vaccines/human_referral_prac_000053.jsp%26mid%3DWC0b01ac05805c516f

 

US National Cancer Institute (NCI) designated Cancer Centers declare that low uptake rates of HPV vaccination constituted a serious public health threat. They further state that HPV vaccination represents a rare opportunity to prevent many cases of cancer and save lives.

https://www.mdanderson.org/content/dam/mdanderson/documents/prevention-and-screening/NCI_HPV_Consensus_Statement_012716.pdf

 

European Commission endorses the conclusion of the EMA stating that there is no need to change the way HPV vaccines are used or to amend the product information. This final outcome by the Commission is now binding in all member states.

https://www.kildarestreet.com/wrans/?id=2016-10-26a.374

 

2015

December

WHO reports there are no safety issues with the use of HPV vaccines.

Global Advisory Committee on Vaccine safety Statement on Safety of HPV vaccines 17 December 2015

http://www.who.int/vaccine_safety/committee/GACVS_HPV_statement_17Dec2015.pdf

 

September

Multinational study finds no increase in the incidence of serious adverse events associated with HPV vaccination compared with background rates.

Vichnin M, Bonanni PKlein N et al. An Overview of Quadrivalent Human Papillomavirus Vaccine Safety: 2006 to 2015. Pediatr Infect Dis J. 2015 Sep;34(9):983-91.

https://www.ncbi.nlm.nih.gov/pubmed/26107345

 

August

Nordic region study finds that Gardasil provides protection for at least 9 years following vaccination.

Nygård MSaah AMunk CTryggvadottir LEnerly EHortlund MSigurdardottir LGVuocolo SKjaer SKDillner J. Evaluation of the Long-Term Anti-Human Papillomavirus 6 (HPV6), 11, 16, and 18 Immune Responses Generated by the Quadrivalent HPV Vaccine. Clin Vaccine Immunol. 2015 Aug;22(8):943-8.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4519713/pdf/zcd943.pdf

 

Japanese Society of Obstetrics and Gynecology demands the resumption of recommendations for HPV vaccination with the aim of eradicating cervical cancer.

http://www.jsog.or.jp/english/declaration_20150829.html

 

Australian review concludes that HPV vaccines are highly efficacious (>90%) at preventing infection and related cervical intraepithelial neoplasia and has proven efficacy in both sexes and against HPV16/18/6/11 related vulvar, vaginal, penile and anal intraepithelial neoplasia and genital warts. There are no safety concerns.

Brotherton J​‌HPV prophylactic vaccines: lessons learned from 10 years experience Future Virology August 2015 ,Vol. 10, No. 8, Pages 999-1009

http://www.futuremedicine.com/doi/abs/10.2217/fvl.15.60?journalCode=fvl

June

EMA approves Gardasil 9 vaccine for use in males and females from nine years to protect against precancerous lesions (growths) and cancers in the cervix, vulva or vagina and anus and genital warts caused by nine types of the human papillomavirus (HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58).

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003852/human_med_001863.jsp&mid=WC0b01ac058001d124

 

May

 Australian study confirms there was a decline in the diagnosis of genital warts 7 years following introduction of the national Gardasil vaccination programme

Chow EPRead TRWigan RDonovan BChen MYBradshaw CSFairley CK.

Ongoing decline in genital warts among young heterosexuals 7 years after the Australian human papillomavirus (HPV) vaccination programme. Sex Transm Infect. 2015 May;91(3):214-9.

http://sti.bmj.com/content/91/3/214.full.pdf+html

 

January

Scandinavian study finds vaccinated girls were no more likely than unvaccinated girls to develop multiple sclerosis (MS) or other similar diseases.

Scheller NM, Svanström H, Pasternak B, Arnheim-Dahlström L, Sundström K, Katharina Fink K, et al. Quadrivalent HPV vaccination and risk of multiple sclerosis and other demyelinating diseases of the central nervous system. JAMA. 2015 Jan; 313(1):54-61.

http://jamanetwork.com/journals/jama/fullarticle/2088853

 

Australian study confirms that the introduction of the national Gardasil vaccination Programme led to a reduction in the diagnoses of genital warts nationally among females (89.9%) and had indirect benefits to males (38.3%).

Smith MALiu BMcIntyre PMenzies RDey ACanfell K. Fall in genital warts diagnoses in the general and indigenous Australian population following implementation of a national human papillomavirus vaccination program: analysis of routinely collected national hospital data. J Infect Dis. 2015 Jan 1;211(1):91-9.

http://jid.oxfordjournals.org/content/211/1/91.full.pdf+html

 

A US study finds no safety concerns for pregnant women who received Gardasil, or for their babies. ****Gardasil is not recommended during pregnancy. However, some women may receive the Gardasil shot before realising they are pregnant.

Moro PL, Zheteyeva Y, Lewis P, Shi J, Yue X, Museru OI, et al. Safety of quadrivalent human papillomavirus vaccine (Gardasil®) in pregnancy: Adverse events among non-manufacturer reports in the Vaccine Adverse Event Reporting System, 2006-2013. Vaccine. 2015 Jan; 33(4): 519-22.

http://www.sciencedirect.com/science/article/pii/S0264410X14016041

2014

December

FDA approves Gardasil 9 for the prevention of cervical, vulvar, vaginal and anal cancers caused by HPV types 16, 18, 31, 33, 45, 52 and 58, and for the prevention of genital warts caused by HPV types 6 or 11. FDA states that Gardasil 9 has the potential to prevent approximately 90% of cervical, vulvar, vaginal and anal cancers.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm426485.htm

 

Multinational study finds that after 4 years follow up, Gardasil is protective against HPV infections and cervical abnormalities associated with HPV 16/18 and infections with the non-vaccine HPV types 31 and 45.

Skinner SRSzarewski ARomanowski B, et al.Efficacy, safety, and immunogenicity of the human papillomavirus 16/18 AS04-adjuvanted vaccine in women older than 25 years: 4-year interim follow-up of the phase 3, double-blind, randomised controlled VIVIANE study.Lancet. 2014 Dec 20;384(9961):2213-27http://www.sciencedirect.com/science/article/pii/S014067361460920X

 

September

US study finds Gardasil protects boys and girls aged 9 to 15 years for at least 8 years following vaccination.

Ferris D, Samakoses R, Block, S.L, et al, Long Term Study of a Quadrivalent Human Papilloma Virus Vaccine, Pediatrics 2014, 134: e657-e665

http://pediatrics.aappublications.org/content/134/3/e657.long

 

August

Brazilian study finds Cervarix vaccine (HPV 16&18) protected women against HPV 16 and 18 after 9.4 years of follow up. There were no safety concerns.

Naud PS, Roteli-Martins CM, De Carvlho NS et al. Sustained efficacy, immunogenicity and safety of the HPV-16/18 ASO4 adjuvanted vaccine: Final analysis of a long-term follow-up study up to 9.4 years post-vaccination. Human Vaccines & Immunotherapeuthics 2014; 10(8)

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4896780/pdf/khvi-10-08-10929532.pdf

 

US experts call on healthcare providers to provide the same strong recommendation for HPV vaccination as they do for other adolescent vaccines in order to play an active role in HPV-related cancers prevention.

http://www.nfid.org/homepage/additional-offerings/hpv-call-to-action.pdf

 

July

Danish study finds Gardasil was not associated with venous thromboembolism (blood clots).

Scheller NM, Pasternak B, Svanström H, Hviid A. Quadrivalent human papillomavirus vaccine and the risk of venous thromboembolism. JAMA. 2014 Jul;312(2):187-8.

http://jamanetwork.com/journals/jama/fullarticle/1886177

 

May

German study finds that antibody responses to a 2 dose schedule of Gardasil vaccine in girls aged 9-14 years is comparable to the standard 3 dose schedule.

Romanowski BSchwarz TFerguson L, et al. Immune response to the HPV-16/18 AS04-adjuvanted vaccine administered as a 2-dose or 3-dose schedule up to 4 years after vaccination: results from a randomized study.Hum Vaccin Immunother. 2014;10(5):1155-65.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4896558/pdf/khvi-10-05-10928022.pdf

 

Danish study finds the incidence of anogenital warts reduced among med (50%0 and women (67%) following introduction of the national HPV vaccine programme.

Sando N, Kofoed KZachariae CFouchard J. A reduced national incidence of anogenital warts in young Danish men and women after introduction of a national quadrivalent human papillomavirus vaccination programme for young women--an ecological study.Acta Derm Venereol. 2014 May;94(3):288-92. https://www.medicaljournals.se/acta/content/abstract/10.2340/00015555-1721

 

April

European Commission grants marketing authorisation for a 2-dose schedule of Gardasil vaccine for children aged from 9 -13 years.

 

French study finds there is no evidence of an increase in the risk of autoimmune disorders following Gardasil vaccination.

Grimaldi-Bensouda L, Guillemot D, Godeau B, et al. Autoimmune disorders and quadrivalent human papillomavirus vaccination of young female subjects. J Intern Med. 2014 Apr; 275(4):398-408. Epub 2013 Nov 22. http://onlinelibrary.wiley.com/doi/10.1111/joim.12155/epdf

 

March

WHO evidence review concludes that there are no safety issues with Gardasil vaccine. WHO states that allegations of harm based on weak evidence can lead to real harm when, as a result, safe and effective vaccines cease to be used.

http://www.who.int/vaccine_safety/committee/topics/hpv/GACVS_Statement_HPV_12_Mar_2014.pdf

 

2013

December

Columbian study finds that Gardasil vaccination of 24-45 year-old women protects against HPV 6-, 11-, 16-, and 18-related genital warts and cervical dysplasia for 6 years.

Luna JPlata MGonzalez MCorrea AMaldonado INossa CRadley DVuocolo SHaupt RSaah A.Long-term follow-up observation of the safety, immunogenicity, and effectiveness of Gardasil in adult women.PLoS One.2013 Dec 31;8(12) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3877052/pdf/pone.0083431.pdf

 

Brazilian study finds that HPV prevalence was much lower among vaccinated compared to unvaccinated women four years after Cervarix vaccination, suggesting protection against oral HPV infection, and associated oropharyngeal cancer.

Herrero R, Quint W, Hildesheim A, Gonzalez P, Struijk L, Katki H, Porras C, Schiffman M, Rodriguez A, Solomon D, Jimenez S, Schiller J, Lowy D, van Doorn L, Wacholder S, Kreimer A,CVT Vaccine Group Reduced Prevalence of Oral Human Papillomavirus (HPV) 4 Years after Bivalent HPV Vaccination in a Randomized Clinical Trial in Costa Rica

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3714284/pdf/pone.0068329.pdf

 

November

UK study finds that the HPV vaccine programme had led to a reduction in genital wart diagnoses at Genitourinary medicine clinics.

Howell-Jones RSoldan KWetten SMesher DWilliams TGill ONHughes G.

Declining genital Warts in young women in england associated with HPV 16/18 vaccination: an ecological study.J Infect Dis. 2013 Nov 1;208(9):1397-403.

http://jid.oxfordjournals.org/content/208/9/1397.full.pdf+html

 

October

Scandinavian study finds that Gardasil was not associated with blood clots or adverse events related to the autoimmune and brain systems.

Arnheim-Dahlström L, Pasternak B, Svanström H, Sparén P, Hviid A. Autoimmune, neurological, and venous thromboembolic adverse events after immunisation of adolescent girls with quadrivalent human papillomavirus vaccine in Denmark and Sweden: Cohort study. BMJ. 2013 Oct;347:f5906.

http://www.bmj.com/content/bmj/347/bmj.f5906.full.pdf

 

Australian study finds that population-based HPV vaccination program in schools significantly reduced cervical abnormalities for vaccinated women within five years of implementation.

Gertig DBrotherton JBudd ADrennan KChappell GSaville A.Impact of a population-based HPV vaccination program on cervical abnormalities: a data linkage study. BMC Med.2013 Oct 22;11:227.

https://www.ncbi.nlm.nih.gov/pmc/articles/pmid/24148310/

 

August

US study finds that increased uptake of HPV vaccine among adolescent females coincided with a reduction in the annual rate of high-grade cervical and adenocarcinoma in situ in females ages 21 to 24 years.

Niccolai LJulian PMeek JMcBride VHadler JSosa L.  Declining rates of high-grade cervical lesions in young women in Connecticut, 2008-2011. Cancer Epidemiol Biomarkers Prev. 2013 Aug;22(8):1446-50.

http://cebp.aacrjournals.org/content/22/8/1446.long

 

US study finds that vaccine-type HPV prevalence decreased by 56% among females aged 14-19 years within 4 years of vaccine introduction.

Markowitz LHariri SLin CDunne ESteinau MMcQuillan GUnger E. Reduction in human papillomavirus (HPV) prevalence among young women following HPV vaccine introduction in the United States, National Health and Nutrition Examination Surveys, 2003-2010. J Infect Dis. 2013 Aug 1;208(3):385-93.

http://jid.oxfordjournals.org/content/208/3/385.full.pdf+html

 

July

American Academy of Pediatrics (AAP) and US CDC states that HPV vaccine is an anti-cancer vaccine and that preteen and teens are relying on the adults in their lives to help protect them and that no serious safety concerns have been identified. http://www.cdc.gov/media/releases/2013/p0725-HPV-vaccine.html

 

The International Federation of Gynecology and Obstetrics (FIGO) supports the continued administration of the HPV vaccines and states the vaccines are safe.

http://www.figo.org/news/figo-statement-hpv-vaccination-safety-0014668

 

June

WHO states that following review of evidence from all sources there were no HPV vaccine safety concerns.

http://www.who.int/vaccine_safety/committee/topics/hpv/130619_HPV_VaccinesGACVSv2.pdf?ua=1

 

 2012

February

US study finds girls who received Gardasil were not more likely to develop autoimmune disorders than those who were unvaccinated.

Chao C, Klein NP, Velicer CM, Sy LS, Slezak JM, Takhar H, et al. Surveillance of autoimmune conditions following routine use of quadrivalent human papillomavirus vaccine. J Intern Med. 2012 Feb; 271(2):193-203. Epub 2011 Nov.

http://onlinelibrary.wiley.com/doi/10.1111/j.1365-2796.2011.02467.x/epdf

 

Multicentre (US, Canada and Brazil) study demonstrates that women aged 15-25 years were protected against HPV types 16 and 18 cervical changes 8.4 years after Cervarix vaccination.

Roteli-Martins, C.M., Naud, P., De Borba, P. et al. Sustained immunogenicity and efficacy of the HPV-16/18 AS04-adjuvanted vaccine: up to 8.4 years of follow-up. Human Vaccin Immunother. 2012; 8: 390–397

http://www.tandfonline.com/doi/full/10.4161/hv.18865#aHR0cDovL3d3dy50YW5kZm9ubGluZS5jb20vZG9pL3BkZi8xMC40MTYxL2h2LjE4ODY1P25lZWRBY2Nlc3M9dHJ1ZUBAQDA=

 

2011

October

US study finds women and girls who received Gardasil were no more at risk of allergic reactions, anaphylaxis (severe allergic reaction), Guillain–Barré Syndrome (GBS), stroke, blood clots, appendicitis, or seizures than those who were unvaccinated or who received other vaccines.

Gee J, Naleway A, Shui I, Baggs J, Yin R, Li R, et al. Monitoring the safety of quadrivalent human papillomavirus vaccine: Findings from the Vaccine Safety Datalink. Vaccine. 2011http://www.sciencedirect.com/science/article/pii/S0264410X11013831

 

Costa Rican study finds that Cervarix resulted in complete protection HPV16 and HPV18 infections and partial protection against HPV31, 33, and 45 in HPV-naïve young women.

Bosch Fde Sanjose SCastellsague X.The prospects of HPV vaccination in cervical cancer prevention: results of a new independent trial. Cancer Discov. 2011 Oct;1(5):377-80

http://cancerdiscovery.aacrjournals.org/content/1/5/377.long

 

September

Catch-up programme is introduced, with all girls in sixth year or equivalent from 2011 to 2014 offered Gardasil.

http://www.hse.ie/eng/health/immunisation/hcpinfo/guidelines/chapter10.pdf

 

July

US review finds that Cervarix has the potential to reduce the incidence of cervical cancer from the current 50–80/100,000 women to 9.5/100,000 women.

Harper, D. M., & Vierthaler, S. L. (2011). Next Generation Cancer Protection: The Bivalent HPV Vaccine for Females. ISRN Obstetrics and Gynecology, 2011, 457204. http://doi.org/10.5402/2011/457204

 

June

Australian study finds a reduction in the number of high grade cervical lesions within 3 years of the introduction of the national HPV vaccination programme.

Brotherton JFridman MMay CLChappell GSaville AMGertig DM.Early effect of the HPV vaccination programme on cervical abnormalities in Victoria, Australia: an ecological study. Lancet. 2011 Jun 18;377(9783):2085-92.

http://www.sciencedirect.com/science/article/pii/S0140673611605515

 

February

US study finds that Gardasil prevents infection with HPV-6, 11, 16, and 18 and the development of related external genital lesions in males 16 to 26 years of age.

Giuliano APalefsky JGoldstone SMoreira EPenny MAranda CVardas EMoi HJessen HHillman RChang YFerris DRouleau DBryan JMarshall JVuocolo SBarr ERadley DHaupt RGuris D. Efficacy of quadrivalent HPV vaccine against HPV Infection and disease in males. N Engl J Med. 2011 Feb 3;364(5):401-11. http://www.nejm.org/doi/pdf/10.1056/NEJMoa0909537

 

January

Australian study finds diagnoses of genital warts reduced by 59% for young female residents after introduction of Gardasil vaccination programme.

Donovan BFranklin NGuy RGrulich AERegan DGAli HWand HFairley CK. Quadrivalent human papillomavirus vaccination and trends in genital warts in Australia: analysis of national sentinel surveillance data.Lancet Infect Dis. 2011 Jan;11(1):39-44.

http://www.sciencedirect.com/science/article/pii/S1473309910702255

 

2010

September

HPV Vaccine school programme is introduced in Ireland.

http://www.hse.ie/eng/health/immunisation/hcpinfo/guidelines/chapter10.pdf

 

2009

October

FDA approves Cervarix for the prevention of cervical cancer, and precancerous lesions by HPV types 16 and 18.

http://www.fda.gov/biologicsbloodvaccines/vaccines/approvedproducts/ucm186959.htm

 

August

U.S. Centers for Disease Control and Prevention (CDC) and FDA confirms that Gardasil is safe, effective and that benefits outweigh risks.

http://www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/VaccineSafety/ucm179549.htm

 

WHO states that the evidence on the safety of HPV vaccines is reassuring.

WHO Weekly Epidemiological Record No. 32, 2009, 84, 325–332

http://www.who.int/vaccine_safety/committee/reports/wer8432.pdf?ua=1

 

February

EMA recommends continued vaccination with Gardasil and concludes that the benefits of Gardasil outweigh the risks.

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2009/11/news_detail_000113.jsp&mid=WC0b01ac058004d5c1

 

2008

September

FDA extends Gardasil licence indication to include prevention of vaginal and vulvar cancers related to HPV types 16 and 18.

http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM111274.pdf

 

2007

 September

WHO concludes that HPV vaccine reduces the risk of cervical cancer.

Bulletin of the World Health OrganizationVolume 85:  Number 9, September 2007, 649-732

http://www.who.int/bulletin/volumes/85/9/06-038414/en/

 

July

WHO Global Advisory Committee on Vaccine Safety (GACVS) states that the current evidence on the safety of HPV vaccines is reassuring.

WHO Weekly Epidemiological Record Nos. 28/29, 2007, 82, 245–260

http://www.who.int/vaccine_safety/committee/reports/wer8228_29.pdf?ua=1

 

2006

September

European Medicines Agency (EMA) grants a marketing authorisation for Gardasil vaccine throughout the European Union, including Ireland.

http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000703/human_med_000805.jsp

This page was added on 10 August 2017

 

June

US Food and Drug Administration (FDA) approves Gardasil for the prevention of cervical cancer, and precancerous lesions by HPV types 6, 11, 16 and 18.

http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm111283.htm

 

This page was updated on 10 August 2018