Safety of HPV vaccination: A FIGO STATEMENT

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1 FIGO Statement n HPV Vaccinatin Safety, August 2nd, 2013 Safety f HPV vaccinatin: A FIGO STATEMENT July, 2013 Human papillmavirus vaccines are used in many cuntries; glbally, mre than 175 millin dses have been distributed. Extensive pre and pst licensure data n the safety f the vaccines are available. Surces f infrmatin t evaluate the safety f the HPV vaccines have included: 1. Randmised cntrlled clinical trials 2. The US Vaccine Adverse Event Reprting System (VAERS) 3. Surveillance f Adverse Events Fllwing Vaccinatin in the cmmunity (SAEFVIC), Victria, Australia established in Eurpean Medicines Agency, Pst licensure experience a. Passive surveillance b. Passive and active surveillance c. Ppulatin based Epidemilgic surveillance Randmised cntrlled trials perfrmed prir t licensure in a number f cuntries, t which new trials in cuntries such as Krea, China, Japan and Vietnam have been added Safety endpints have included lcal and systemic adverse events (AEs), serius AEs, deaths, new nset medical cnditins, including chrnic and/r autimmune diseases, as well as pregnancy utcmes Safety Findings f clinical trials f the quadrivalent vaccine: Pled analyses f trials invlving mre than females aged 9 26 years and 1350 males aged 9 16 years frm Eurpe, Nrth and Suth America, shwed that injectin site reactins such as pain, erythema and swelling were mre cmmn in vaccine recipients than in thse wh received adjuvant r placeb vaccinatins. In almst all cases, symptms were self limiting and reslved within 48 hurs There was n difference in cmmn adverse experiences such as headache, fever and nausea There was als n difference in the frequency f SAEs verall r by rgan system ver a median fllw up f just under 4 years Deaths ccurred in 0.1% in bth the vaccine and placeb grups, with n deaths deemed vaccine related The verall prprtin f participants reprting new nset autimmune cnditins was nt different in each grup (2.4% in bth) ver the 4 year fllw up perid Safety findings f clinical trials f the bivalent vaccine The safety prfile frm clinical studies f the bivalent vaccine is cnsistent with that f the quadrivalent vaccine with pain at the injectin site being the mst cmmn finding (up t 97% f thse vaccinated in data pled frm 11 studies invlving ver females lder than 10 years), and erythema and swelling There were n significant differences in SAEs, unslicited symptms and medically significant cnditins in the vaccinated cmpared t the cntrl grups 1 P a g e

2 FIGO Statement n HPV Vaccinatin Safety, August 2nd, deaths were reprted (nly ne f whm received vaccine), and nne were cnsidered vaccine related In fllw up studies ver 4 year perids, rate f vaccine related SAEs, new nset chrnic disease and new nset autimmune disease was n different between the tw grups In summary: All randmised clinical trials f bth the bivalent and quadrivalent vaccines prvide evidence f an excellent safety prfile. The mst cmmn cmplaint was pain at the injectin site which was largely self limiting and reslved spntaneusly Special circumstances Safety in Pregnancy HPV vaccinatins are nt recmmended fr use in pregnant wmen, hwever sme participants did becme pregnant during the clinical trials Pregnancy registries have been established fr bth cmmercially available vaccines Pregnancy utcmes were the same in the bivalent and quadrivalent vaccines cmpared t cntrl recipients and the general ppulatin. There is n evidence frm either clinical trials nr pst licensure data that there is an increase in cngenital anmalies r bstetric cmplicatins in wmen receiving vaccine Pst licensure data Data frm passive, active and ppulatin based epidemilgic surveillance studies cnducted since 2006, have nt shwn any difference in cnditins such as Guillain Barre Syndrme, strke, appendicitis, seizures, allergic reactins, anaphylaxis and venus thrmbemblism these data were btained frm the Vaccine Safety Datalink chrt in which a ttal f dses f the quadrivalent vaccine were recrded. A medical recrd review f all 8 vaccinated ptential venus thrmbemblism cases in the age grup 9 17 years, 5 cases cmplied with the standard definitin f VTE and all five had knwn risk factrs fr VTE (ral cntraceptin use, cagulatin disrders, smking, besity r prlnged hspitalisatin) Specific cnditins Syncpe Disprprtinately higher rates f syncpe after HPV Vaccinatin cmpared with pre licensure RCTs were reprted frm pst licensure surveillance in the Netherlands, Australia, and Italy. Cnsidering that injectin site pain is cmmn in HPV vaccinatin, syncpe is cnsidered an uncmmn side effect rather than an adverse event t vaccinatin, and the recmmendatin is t take precautins (such as sitting 2 P a g e

3 FIGO Statement n HPV Vaccinatin Safety, August 2nd, 2013 after injectin) t prevent falling if dizziness r fainting ccurs, stressing the necessity fr clse bservatin fr minutes pst vaccinatin Syncpe in wmen vaccinated against HPV des nt appear t be mre cmmn than that reprted with ther types f vaccinatin. The Center fr Disease Cntrl and Preventin evaluated syncpe after the licensure f three vaccines: the HPV quadrivalent vaccine, the quadrivalent meningcccal cnjugate vaccine in a single dse and the tetanus txid, reduced diphtheria txid and acellular pertussis vaccine in a single dse and fund that the incidence f syncpe was similar and advised that in all cases f administering vaccinatin, patients shuld be bserved fr at least 15 minutes after vaccinatin (as is recmmended by the Advisry Cmmittee n Immunizatin Practices) in rder t prevent injuries related t syncpe. Anaphylaxis Althugh rare, anaphylaxis can ccur after any vaccinatin either due t the antigen and/r vaccine adjuvant Reprting rates f anaphylaxis fllwing HPV vaccinatin have been cnsistent in bth natinal passive surveillance and ppulatin based studies and fund t be in the estimated range f 1 10 cases per millin dses, which cmpares favurably with ther vaccines such as tetanus txid, reduced diphtheria txid and acellular pertussis vaccines. Guillain Barre Syndrme (GBS) A review f GBS cases reprted t the US VAERS suggested a ptentially time greater rate f GBS within 6 weeks after vaccinatin with the quadrivalent vaccine cmpared t that expected in the general ppulatin. After extensive investigatin, it was cncluded that the tempral relatinship t vaccinatin and lack f a cntrl grup meant further investigatin was required. Subsequent ppulatin based studies using extensive case finding have nt prvided evidence f a rate that is significantly greater than that expected in the adlescent and yung female ppulatin. Venus Thrmbemblism (VTE) VTE pst vaccinatin has nly been rarely reprted and all cases had ther risk factrs fr VTE such as ral cntraceptive use. In additin, the tempral relatinship t vaccinatin was highly variable making this unlikely t be a vaccine related cmplicatin. Cmplex Reginal Pain Syndrme (CRPS) AE fllwing immunisatin cmmnly include lcal pain at the injectin site, but the develpment f CPRS, has nly been described in children immunised with rubella and hepatitis B vaccines. CPRS is a clinical syndrme 3 P a g e

4 FIGO Statement n HPV Vaccinatin Safety, August 2nd, 2013 that affects ne r mre extremities and is characterised by persistent pain disprprtinate t the initiating event, which is ften minr trauma 4 cases were reprted t the Surveillance f Adverse Events fllwing Vaccinatin in the Cmmunity after it was initiated in Victria, Australia 2007, and ne case frm the UK 4 f the 5 cases met the criteria fr CPRS and all reslved within 5 days t 7 mnths withut recurrence r cnsequence It is imprtant t be aware f this syndrme which can be triggered by any injury t the extremity, including intra muscular injectin. Cases f chrnic pain in the extremities have been reprted in Japan where ver 8 millin dses f HPV vaccine have been distributed the issue is being intensively investigated but data received t date des nt cnvincingly implicate HPV vaccinatin, as ppsed t any ther type f vaccinatin 4 P a g e

5 FIGO Statement n HPV Vaccinatin Safety, August 2nd, 2013 Cnclusins The Glbal Advisry Cmmittee n Vaccine Safety (GACVS) f the Wrld Health Organisatin (WH0), reviewed the safety f HPV vaccinatin n June 13, 2013, the Cmmittee s last review having taken place in The Cmmittee cnsidered all available evidence n HPV vaccinatin and have cncluded that bth cmmercially available vaccines are safe. Having reviewed all available data, the FIGO Gyneclgic Onclgy Cmmittee and the FIGO sub cmmittee fr Cervical Cancer Preventin supprts the cntinued administratin f the HPV vaccines in apprpriate ppulatins. This recmmendatin has been apprved by the FIGO Executive Bard Signed by: Prfessr Sabaratnam Arulkumaran: President FIGO Prfessr Lynette Denny: Chair, FIGO Gyneclgic Onclgy Cmmittee Prfessr Janna Cain: Chair: Sub Cmmittee fr Cervical Cancer Preventin Date: 5 P a g e

6 FIGO Statement n HPV Vaccinatin Safety, August 2nd, 2013 References: VSstatement.pdf Macartney KK, Chiu C, Gergusakis M, Brthertn JML. Safety f Human Papillmavirus Vaccines: A Review. Drug Saf 2013;36: Gee J, Naleway A, Shui I, Baggs J, Yin R, Rng Li et al. Mnitring the safety f quadrivalent human papillmavirus vaccine: Findings frm the Vaccine Safety Datalink. Vaccine 2011;29: Klein NP, Hansen J, Cha C, Velicer C, Emery M, Slezak et al. Safety f Quadrivalent Human Papillmavirus Vaccine Adminstered Rutinely t Females. Arch Pediatr Adlesc Med. 2012;166: Centers fr Disease Cntrl and Preventin. Syncpe after vaccinatin Unites States, January MMWR Mrb Mrtal Wkly Rep. 2008:57(!&): Chang s, O Cnnr PM, Slade BA, W EJ. U.S. Pstlicensure safety surveillance fr adlescent and adult tetanus, diphtheria and acellular pertussis vaccines: Vaccine 2013;31(10): Richards S, Chailkiadis G, Laksham R, Buttery JP, Crawfrd NW. Cmplex reginal pain syndrme fllwing immunisatin. Arch Dis Child 2012;97: P a g e

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