DIPHTHERIA EVIDENCE TO RECOMMENDATIONS TABLE i

Transcription

1 DIPHTHERIA EVIDENCE TO RECOMMENDATIONS TABLE i Me infmation can be found in the review of the epidemiology of diphtheria systematic review on immunogenicity to asss the duration of protection 10 years after the last diphtheria booster dose and in the summary of the Strategic Advisy Group of Experts (SAGE) on Immunization. 2,3 Qution: What is the duration of continued seroprotection of diphtheria vaccination ( 10 years) conveyed by a specific schedule of diphtheria toxoid (- containing) vaccination which is comprised of at least 3 vaccine dos (primary seri) and 3 booster dos until adulthood. Population: Immunocompetent children and adults. Intervention: Vaccination with diphtheria toxoid (-containing) vaccination. Comparison: vaccination, different duration between vaccination and serological tting. Outcome: Diphtheria serum antibody levels/ seroprevalence. Background: Throughout histy, diphtheria has been one of most feared childhood diseas globally, characterized by devastating epidemics affecting mainly children. The current WHO recommendation which dat back from 2006 stat that a primary seri of diphtheria-tetanus acellular/wholecell pertussis (DTwP)- (DTaP)-(containing) vaccin should be administered in 3 dos, starting as early as 6 weeks of age, and given with a minimum interval of 4 weeks. To compensate f the loss of natural boosting, industrialized countri should add childhood boosters of diphtheria toxoid to the primary immunization seri of infancy. Booster dos should be given after the completion of the primary seri. Boosting at the age of 12 months, at school entry and just befe leaving school are all possible options, based on the local epidemiology. In addition to childhood (and adolcent) immunizations, WHO currently recommends that people living in low-endemic nonendemic areas may require booster injections of diphtheria toxoid at about 10-year intervals to maintain life-long protection. A review of diphtheria epidemiology 1 and a systematic review of literature 2 was conducted to asss the need f administration of decennial diphtheria toxoid booster dos in adulthood. In April 2017, SAGE revisited this current recommendation in light of primary immunization plus 3 booster dos administered until adulthood. 1 Review of diphtheria epidemiology accsed May Systematic review of duration of protection. accsed May Summary of the April 2017 meeting of the Strategic Advisy Group of Experts on Immunization. accsed May

2 PROBLEM BENEFITS & HARMS OF THE OPTIONS CRITERIA JUDGEMENTS RESEARCH EVIDENCE ADDITIONAL INFORMATION Uncertain by Diphtheria is well-controlled in the majity of Is the problem a setting countri globally. Neverthels, several largcale outbreaks have been repted in the recent public health priity? past, in particular from the South-East Asian region. Benefits of the Are the dirable anticipated effects large? Harms of the Are the anticipated effects small? Uncertain Uncertain Diphtheria toxoid is one of the oldt vaccin in current use. Diphtheria vaccination has led to a drastic decline of cas since its inclusion in the Expanded Programme f Immunization (EPI) in 1974 (with diphtheria vaccine as one of the iginal six EPI antigens). The incidence of diphtheria decreased dramatically wldwide. During the period , the total number of repted diphtheria cas was reduced by >90%. The benefit of the would be an overall reduction of the number of diphtheria toxoid vaccine. Benefits would entail reduced direct and indirect costs, benefits f the vaccine recipient with reduced number of health care visits and injections as well as programmatic benefits. Diphtheria toxoid is one of the saft vaccin available. However, local reactions at the site of injection are common, although repted rat differ (<10 to >50%). Severe reactions are rare, and to date no anaphylactic reactions attributable to the diphtheria component have been dcribed. With reduction of the number of dos received, the risk of adverse events would 2

3 decrease. Balance between benefits and harms Favo urs interv ention Favo urs compar ison Favour s both Favours neither Uncl ear Balancing benefits and harms of the and the comparison, clearly favours the. What is the overall cert of this evidence f the critical outcom? Effectivens of the included Very studi low Low Modera te High F detailed infmation on the cert of evidence f the critical outcom, please see: We are highly confident that 6 dos of diphtheria toxoid containing vaccin convey a protective immunity until at least age 39, likely longer. Safety of the included Very studi low Low Modera te High Concerning the safety of the, we did not list a quality rating, as GARDE profil on DTP vaccin from randomized controlled trials and observational studi are available in the following systematic review of literature. ings/2015/april/8_safety_dtp_rcts_obs_stud i_draft.pdf?ua=1 3

4 VALUES & PREFERENCES How certain is the relative imptance of the dirable and outcom? Imp Possib ly imp Proba bly no imp imp known undi rable outco m evidence available though it is assumed that in general there is no imp. Valu and preferenc of the target population: Are the dirable effects large relative to effects? Proba bly Uncert Proba ain bly It is prumed that the dirable effects (reduced number of health care visits/injections) are large relative to effects ( of overall duration of protection). RESOURCE USE Are the rourc required small? Costeffectivens Uncert ain Uncert ain rourc needed f the. The costs of diphtheria (-containing) vaccin are already low. n administration of decennial booster dos will further reduce indirect an direct costs and reduce the necsary rourc. 4

5 EQUITY ACCEPTABILITY What would be the impact on health inequiti? Which option is acceptable to key stakeholders (Ministri of Health, Immunization Managers)? Which option is acceptable to target group? Increa sed Interv ention Interv ention Uncer tain Reduced Comp arison Both Neither Comp arison Both Neither Uncl ear Uncl ear Health inequaliti would be decreased without the administration of decennial booster dos, which may be affdable only in some countri. n- administration of decennial booster dos is prumed to be an acceptable option to key stakeholders. As no additional injections (using combination vaccin) and ls health care visits are needed (without decennial booster dos), the s is acceptable to the target population. FEASIBILITY Is the feasible to implement? Proba bly Uncert Proba ain bly 5

6 Balance of Undirable clearly outweigh dirable Undirable probably outweigh dirable The balance between dirable and is closely balanced ain Dirable probably outweigh Dirable clearly outweigh Type of recommendation We recommend the We suggt considering recommendation of the Only in the context of rigous rearch We recommend the comparison We recommend against the and the comparison Only with targeted moniting and evaluation Only in specific contexts specific (sub) populations Recommendation (text) Implementation considerations As diphtheria toxoid is almost exclusively administered in fixed combination with other vaccin, immunization programm will need to harmonize immunization schedul between diphtheria, tetanus and, in parts, pertussis vaccination. A primary seri of 3 dos of diphtheria-containing vaccine is recommended followed by 3 booster dos befe adulthood. Decennial diphtheria booster dos are not recommended. With an increasing proption of boys and girls attending school wldwide, immunization programm targeting school-aged children are increasingly imp. This is particularly relevant f the booster dos of diphtheria-containing vaccine. 6

7 Moniting and evaluation Rearch priiti Improved national surveillance and repting systems, with district-level data analysis, are sential. Countri should rept all available data on diphtheria cas, including utilizing data from their integrated disease surveillance and rponse databas and on diphtheria caused by C. diphtheria and C.ulcerans f countri with tablished labaty confirmation. Epidemiological surveillance ensuring early detection of diphtheria outbreaks should be in place in all countri, and all countri should have accs to labaty faciliti f reliable identification of toxigenic C. diphtheriae. Immunity gaps may occur in older age groups due to waning immunity, but available data are insufficient to make firm recommendations. Further studi, including serosurveys, are required to generate infmation on the duration of protection and the need f booster dos in older age groups. Further data should be generated on transmission of cutaneous diphtheria possibly leading to rpiraty diphtheria. i This Evidence to Recommendation table is based on the DECIDE Wk Package 5: Strategi f communicating evidence to infm decisions about health system and public health s. Evidence to a recommendation (f use by a guideline panel). 7