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Strengthening national teams of experts to support HPV vaccine introduction in Eastern Mediterranean countries: Lessons learnt and recommendations from an international workshop
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Strengthening national teams of experts to support HPV vaccine introduction in Eastern Mediterranean countries: Lessons learnt and recommendations from an international workshop Carine Dochez a,⇑, Salah Al Awaidy b, Ezzeddine Mohsni c, Kamal Fahmy d, Mohammed Bouskraoui e a
Network for Education and Support in Immunisation (NESI). Department Epidemiology and Social Medicine. University of Antwerp. Universiteitsplein 1. 2610 Antwerp, Belgium Ministry of Health, Oman Global Health Development/Eastern Mediterranean Public Health Network (GHD/EMPHNET), Jordan d World Health Organization/Regional Office for the Eastern Mediterranean (WHO/EMRO), Egypt e University Cadi Ayyad & Société Marocaine d’Infectiologie Pédiatrique et de Vaccinologie (SOMIPEV), Morocco b c
a r t i c l e
i n f o
Article history: Received 25 April 2019 Received in revised form 11 November 2019 Accepted 12 November 2019 Available online xxxx Keywords: Cervical cancer HPV vaccines Eastern Mediterranean Region NITAGs
a b s t r a c t Several countries have started to introduce the HPV vaccine into their national immunisation programme, with the majority of these countries being high or upper-middle income countries. Currently, 91 countries have introduced the HPV vaccine globally. One of the regions lagging behind in the introduction of the HPV vaccine is the Eastern Mediterranean Region, with currently only Libya and the United Arab Emirates having introduced the HPV vaccine. In order to support countries in the Eastern Mediterranean Region with their decision-making process for HPV vaccine introduction, a regional workshop was organised to explore the current status of HPV vaccine introduction plans in the Eastern Mediterranean countries, gaps in information about HPV disease burden in the region and the need for quality HPV data to make an informed decision to introduce the HPV vaccine, socio-cultural and religious challenges with HPV vaccine introduction, and the role of NITAGs in formulating recommendations for HPV vaccine introduction. Participating countries reflected on their respective status of decision making process about HPV vaccine introduction; they discussed any needs for operational research to support the decision-making process; and highlighed technical and financial support that might be required from partners to assist with HPV vaccine introduction. Recommendations were made on how to advance the decision-making process for HPV vaccine introduction. The workshop increased the awareness of the need of data on burden of disease and the associated benefits of HPV vaccination in Eastern Mediterranean countries. The importance of collaboration between different programmes including: immunisation, adolescent health, school health, sexual and reproductive health and cancer control programmes was clearly emphasized. Ó 2019 Elsevier Ltd. All rights reserved.
1. Introduction and rationale for the workshop Cervical cancer is an important public health problem and is the third leading cause of female cancer in the world [1]. The link between cervical cancer and a persistent infection with high-risk or oncogenic human papillomaviruses (HPV) has been clearly established [2]. Each year, cervical cancer is responsible for around 560,000 new cases and 300,000 deaths worldwide, with the highest burden occurring in low-income countries [1]. Oncogenic HPV types 16 and 18 are responsible for about 70% of cervical cancer ⇑ Corresponding author. E-mail address: [email protected] (C. Dochez).
cases. Non-oncogenic HPV types, like HPV 6 and 11, are responsible for the majority of genital warts [3,4]. In the Eastern Mediterranean Region (EMR), the incidence rates varies between countries. For example, in Djibouti the standardised incidence rate is 13.3/100,000 population, which is close to the global incidence rate of 13.1/100,000 population; while the standardised mortality rate of 10.6/100,000 population is higher than the global mortality rate of 6.9/100,000 population. Morocco has a higher incidence rate of 17.2/100,000 population and a mortality rate of 12.6/100,000. Oman and Bahrain for example have a lower incidence rate of respectively 6.3/100,000 and 3.8/100,000 population, and a mortality rate of repectively 3.9/100,000 and 2.7/100,000 population [1,5].
https://doi.org/10.1016/j.vaccine.2019.11.027 0264-410X/Ó 2019 Elsevier Ltd. All rights reserved.
Please cite this article as: C. Dochez, S. Al Awaidy, E. Mohsni et al., Strengthening national teams of experts to support HPV vaccine introduction in Eastern Mediterranean countries: Lessons learnt and recommendations from an international workshop, Vaccine, https://doi.org/10.1016/j.vaccine.2019.11.027
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HPV vaccines have an enormous potential in the prevention of cervical cancer. Three efficacious and safe HPV vaccines are currently available: the bivalent, quadrivalent and ninevalent vaccine. The vaccines are based on virus-like particles (VLPs). The bivalent vaccine contains VLP antigens for HPV 16/18. The quadrivalent vaccine contains VLP antigens for HPV 6/11/16/18. Evidence exists that both the bivalent and quadrivalent HPV vaccines show cross-reactivity to genotypes not included in the vaccines, especially to HPV 31/33/45 for the bivalent vaccine, and HPV 31 for the quadrivalent vaccine [3]. The ninevalent vaccine contains VLP antigens for HPV 6/11/16/18/31/33/45/52/58 [3]. As HPV can also cause other cancers, like vulvar, anal, penile and oropharyngeal cancer, the vaccines have potential to prevent those cancers as well. The quadrivalent and ninevalent vaccines protect also against genital warts caused by the non-oncogenic HPV types 6 and 11 [3]. All HPV vaccines were originally licensed in a three-dose schedule over a 6 months time period, given as an intramuscular injection to 9–14 year old girls. Currently, WHO recommends a two-dose schedule for 9–14 year olds. The three-dose schedule remains valid for individuals above 15 years of age and for immuno-compromised individuals. These recommendations apply to the three HPV vaccines [3]. Introduction of new vaccines into national immunisation programmes is one of the goals outlined in the Decade of Vaccines (2011–2020) [6]. Several countries have started to introduce the HPV vaccine into their national immunisation programme, with the majority of these countries being high or upper-middle income countries [7]. Currently, 91 countries have introduced the HPV vaccine globally [8]. One of the regions lagging behind in the introduction of the HPV vaccine is the Eastern Mediterranean Region, with currently only Libya and the United Arab Emirates (UAE) having introduced the HPV vaccine [9]. Around 1.2 billion people are aged between 10 and 19 years, i.e. 1 in 6 persons globally is an adolescent. Protecting adolescents now from potential health risks later in adulthood is important and the HPV vaccine provides this opportunity for the prevention of HPV related cancers [10]. Being a vaccine targeting adolescents, any HPV vaccination programme might face some potential public health challenges: (1) a strong adolescent health or school-based vaccination programme need to be in place to successfully deliver the HPV vaccine; (2) the involvement of multiple authorities at country level (Ministry of Health and Ministry of Education); (3) addressing sociobehavioural issues (e.g. gender issues as girls are being targeted, parental consent, potential stigma of HPV being a sexually transmitted infection); and (4) a delay in demonstrating health benefits as cervical cancer takes many decades to develop. As informed earlier, in the Eastern Mediterranean Region the cervical cancer incidence rates vary between countries, with the highest incidence rate observed in Somalia (24/100,000 population) and the lowest in Iraq (1.9/100,000 population) [1,5]. However, several countries in the region lack a national cancer registry, therefore, the exact scale of cervical cancer is difficult to estimate. Several countries provide opportunistic screening, but patients often present with cervical cancer in a late stage with low survival rates [11]. Before starting the introduction of a new vaccine, countries need to make an evidence-based decision whether a new vaccine merits introduction into the national immunisation programme. As more and more new vaccines become available, countries face several challenges in introducing these vaccines in the existing immunisation programme: (a) decision-making and prioritisation of which vaccine(s) to be introduced; (b) addressing strengths and weaknesses in the immunisation programme; (c) managing more complicated vaccination schedules; (d) developing multi-year plans to ensure sustainable use of the new vaccines.
National Immunisation Technical Advisory Groups (NITAGs) are tasked to provide an independent, evidence-based recommendation to their governments [12,13]. Except for Somalia, all countries in the Eastern Mediterranean region, have established a NITAG, though not all are fully functional [14]. 1.1. Objectives of the workshop In order to support countries in the decision-making process for HPV vaccine introduction, a workshop on ‘‘Strengthening national teams of experts to support HPV vaccine introduction in Eastern Mediterranean countries” was organised from 14 to 16 October 2018 in Marrakech, Morocco, by the University Cadi Ayyad, Société Marocaine d’Infectiologie Pédiatrique et de Vaccinologie (SOMIPEV), and the Network for Education and Support in Immunisation (NESI)/University of Antwerp. The workshop received support from the Eastern Mediterranean Regional Office of the World Health Organisation (WHO/EMRO), Global Health Development/Eastern Mediterranean Public Health Network (GHD/EMPHNET) and the Ministry of Health of Oman. Similar workshops have been organised for the Eastern and Southern African Region, which greatly supported the countries with their decision-making process for HPV vaccine introduction [15]. The key target audience included representatives of Ministry of Health (Expanded Programme on Immunisation; Adolescent Health Programme; Non-communicable Disease Programme; School Health Programme), chairs and members of the National Immunisation Technical Advisory Groups (NITAGs), national and international immunisation partners, and other relevant stakeholders. The objectives of the workshop included: (1) To discuss the burden of HPV related diseases, especially cervical cancer, in the Eastern Mediterranean Region; (2) To discuss the available HPV vaccines and their use in national immunisation programmes; (3) To discuss potential adolescent health interventions to be delivered alongside HPV vaccination; (4) To discuss optimal communication strategies for the introduction of HPV vaccination; (5) To exchange lessons learnt and best practices regarding new vaccine introduction, especially HPV vaccine, and adolescent health services among participating countries; (6) To strengthen national teams of experts in the participating countries to make evidence-based recommendations and decisions to support and advocate for the introduction of HPV vaccination; and (7) To strengthen the international community to further stimulate discussion and research on cervical cancer, HPV vaccination and adolescent health. A total of 57 delegates participated in the workshop. From each country the NITAG chair (or member) and 2 Ministry of Health representatives were invited. Nominated delegates that attended the workshop were from the Ministry of Health and/or NITAG members from the following countries: Jordan, Morocco, Palestine, Somalia, Sudan, Tunisia, United Arab Emirates. Nominees from Afghanistan, Djibouti, Iraq, Pakistan, Syria, Saudi Arabia had confirmed their participation, but due to visa related problems were not able to attend. The organisers have tried to set up a WebEx connection for remote participation, but the signal at the venue was not strong enough to support this. Other participants came from academia, national and international organisations, International Islamic Fiqh Academy, Islamic Development Bank, and industry. Facilitators were from: Cadi Ayyad University, SOMIPEV, GHD/EMPHNET, Ministry of Health Oman, WHO/EMRO, IARC/ WHO, London School of Hygiene and Tropical Medicine, Gavi, WHO/Morocco and NESI/University of Antwerp. 2. Activities The workshop explored the current status of HPV vaccine introduction plans in Eastern Mediterranean countries, gaps in
Please cite this article as: C. Dochez, S. Al Awaidy, E. Mohsni et al., Strengthening national teams of experts to support HPV vaccine introduction in Eastern Mediterranean countries: Lessons learnt and recommendations from an international workshop, Vaccine, https://doi.org/10.1016/j.vaccine.2019.11.027
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information about HPV disease burden in the region, and the role of NITAGs in new vaccine introduction. The workshop comprised of interactive presentations, round table discussions, country presentations, including sharing of experiences and best practices, and group work. Prior to the workshop, country delegates were provided with a PowerPoint template to prepare for their respective country presentation.
Table 1 Current status of HPV vaccine introduction in the participating countries from the Eastern Mediterranean Region.
2.2. Day 2: Communication, advocacy, and socio-cultural and religious challenges The second day of the workshop focused on communication and building public trust for HPV vaccination. The plenary presentations were followed by a first round table discussion on ‘‘Overcoming hurdles for HPV vaccine introduction and cervical cancer screening, focusing on socio-cultural and religious challenges”. Experiences of HPV vaccine introduction from other regions were shared by delegates from Indonesia and Senegal. 2.3. Day 3: HPV data and country decision-making The last day started with a second round table discussion, focusing on ‘‘HPV data required to make an evidence-based decision to introduce HPV vaccine; and monitoring HPV vaccination coverage”. During the final session of the workshop, group work was conducted, addressing the following issues: (a) Status of decision-making about HPV vaccine introduction in the participating countries; (b) Any needs for operational research to support the decision-making; (c) Technical and financial support that might be required from partners. Recommendations were made on how to advance the decision-making process for HPV vaccine introduction in the participating countries. 3. Results: Observations and recommendations from the workshop The results section highlights observations and discussions during the workshop. Table 1 summarizes the current status of HPV vaccine introduction in the countries that participated in the workshop. Only UAE has introduced the HPV vaccine. Morocco has concrete plans for HPV vaccine introduction in 2019, if finances are available. The other countries have no concrete plans, as of the date of the workshop, for HPV vaccine introduction. Reasons formulated include: lack of disease data; lack of cancer registry; competing priorities; high costs of the vaccine if the country is not Gavieligible. For example, Tunisia clearly mentioned competing priorities with other vaccines, like pneumococcal conjugate vaccine, hepatitis A vaccine, acellular pertussis and rotavirus vaccine. Morocco had made the decision to introduce the HPV vaccine several years ago, but lack of availability of funds delayed the introduction. 3.1. Importance of the HPV vaccine Key aspects on burden of disease, cervical cancer screening, update on HPV vaccines and cost-effectiveness, and delivery
Status of HPV vaccine introduction*
Jordan Morocco
No current plan for HPV vaccine introduction National HPV vaccine introduction planned for September 2019 No current plan for HPV vaccine introduction No current plan for HPV vaccine introduction No current plan for HPV vaccine introduction No current plan for HPV vaccine introduction HPV vaccine has been introduced: sub-national HPV vaccine introduction in Abu Dhabi in 2008; national introduction in 2018
Palestine Somalia Sudan Tunisia United Arab Emirates
2.1. Day 1: Updates on cervical cancer and HPV vaccines Presentations highlighted key aspects on burden of disease, cervical cancer screening, update on HPV vaccines and costeffectiveness, delivery platform for HPV vaccination, and potential integration with other adolescent health interventions. The role of the NITAGs in the decision-making process for HPV vaccine introduction was thoroughly discussed.
Country
*
At the time of the workshop (October 2018).
platform for HPV vaccination were highlighted. A recap on the virology of the virus, burden of disease caused by HPV and risk factors adding to the development of cervical cancer were discussed. A sero-prevalence study, that has recently started in Morocco, was presented, emphasizing the usefulness of epidemiological studies before the introduction of the vaccine, as well as during the vaccination programme. The characteristics of the different available HPV vaccines were discussed in detail. Programme managers are tasked to evaluate the different options available against programme needs and costs before introducing the HPV vaccine. The introduction of a new vaccine is also an opportunity to reinforce routine immunisation and strenghtening other EPI essentials, as a review of the current immunisation programme is opportune before introducing the new vaccine: e.g. is there full benefit with currently introduced vaccines (high coverage, limited drop-out rate); is the cold chain functional (vaccine storage, monitoring use and wastage); staff training; monitoring immunisation coverage; monitoring adverse events following immunisation (AEFI); is there a disease surveillance system in place.
3.2. Addressing implementation challenges A global overview was given of the countries that have currently introduced the HPV vaccine. The HPV vaccine is special compared to other EPI vaccines given its age of introduction and the target population, i.e. girls of 9–14 year of age. Could this (partially) explain the low uptake of HPV vaccination programmes in the Eastern Mediterranean Region? The main hurdles for HPV vaccine introduction were discussed during the round table discussions and group work.
3.2.1. Advocacy, communication and social mobilization Advocating for the introduction of the HPV vaccine is of outmost importance, reflecting the need of the HPV vaccine being included in the routine immunisation programme. Increasing community awareness through comprehensive, timely and appropriate communication is fundamental to the successful and sustainable introduction of the HPV vaccine. Communication is a key element of any successful public health programme, and investing in communication for the HPV vaccine is particularly important because of its unique features that were highlighted in the previous section. From hesitation to complete refusal, vaccine oppositions represent an obstacle to the prevention of infectious diseases. The refusal of vaccinations can be due to the fear of adverse events, fear maintained by media crises, false information on the Internet and in the media, anti-vaccine movements and various beliefs. The concept of benefit/risk is reversed at the expense of vaccines, and the search for collective benefit is becoming scarce.
Please cite this article as: C. Dochez, S. Al Awaidy, E. Mohsni et al., Strengthening national teams of experts to support HPV vaccine introduction in Eastern Mediterranean countries: Lessons learnt and recommendations from an international workshop, Vaccine, https://doi.org/10.1016/j.vaccine.2019.11.027
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The role of the healthcare professional is essential, but providing information to caregivers and patients requires sufficient time. The current influence of the media and the Internet justifies an international reflection to fight against the nuisance of nonscientific and erroneous information. Vaccine hesitancy has always existed and seems inevitable. However, some polemics can and should be anticipated. We must learn to cope better, especially by using the same weapons as the opponents of vaccination. Communication is a key element of any successful public health programme, and investing in communication for the HPV vaccine is particularly important because of its unique features. Preparation of a strong communication plan before the start of the HPV vaccination programme, as well as a crisis management plan, will ensure the succesfull introduction of the HPV vaccine and to achieve high coverage. 3.2.2. Socio-cultural and religious challenges Socio-cultural and religious challenges need to be taken into account before the introduction of the HPV vaccine. Issues that need to be addresses include gender issues: will only girls be vaccinated and how to discuss this with the general public without creating a negative attitude towards vaccinating girls only. The discussion should also include communication to avoid the potential stigma of HPV being a sexually transmitted infection. The issue of parental consent needs to be addressed. Involvement of all community players, including private sectors, NGOs, women associations, religious and community leaders, is of outmost importance for the successful introduction of the HPV vaccine. 3.2.3. Integration with other adolescent health interventions Few interventions are aimed at adolescents and those that exist do not always reach them. This is because adolescents generally have little contact with the health system. Several health interventions may be proposed at the same time as HPV vaccination and promote synergies between the EPI and school health and/or adolescent health programmes. However, it was observed that the progress with the integration agenda is too little. Workshop participants proposed integration of HPV vaccination with other interventions like reproductive health education and premarriage counseling activities. Before implementing school-based vaccination programmes, countries must be able to assess the capacity, strengths and weaknesses of their education and health systems to support these programmes. School-based immunisation strategies are an opportunity to collaborate with school health programmes when they exist and, more broadly, with the Ministry of Education, to incorporate public health messages into schools. 3.3. The importance of quality HPV data A current study on sero-prevalence in Morocco emphasized the usefulness of epidemiological studies before the start of the HPV vaccination programme, as well as during the vaccination programme. All countries should have a national cancer registry in place, to keep cancer data records in the population in order to measure the burden of disease in communities and to assess the impact of interventions. Workshop participants also recommended that the health information system needs to be strengthened. 3.4. Decision-making process The role of the NITAGs in the decision-making process for HPV vaccine introduction was stressed. To be successful, new vaccine introduction should follow a rational process and different steps
should be considered as part of decision-making: (1) what is the burden of disease to be prevented in terms of morbidity and mortality; (2) is there a good intervention, i.e. is the vaccine efficacious and effective, safe and acceptable for the target population; (3) what is the cost of the new vaccine and of its implementation and what is its comparative effectiveness with other vaccines/ interventions in terms of health gains. Based on the above, a decision can be taken that a new vaccine merits introduction as a public health priority. Before a final decision on introduction of a new vaccine, two other steps are of major importance: (1) are sustainable finances available to pay for the new vaccine; and (2) what are the programmatic implications. Workshop participants emphasized that the decision-making process should include: e.g. pricing issues in low and middleincome countries; prioritization of different vaccines; selecting the HPV vaccine best suited to the country needs; development of implementation plan; integration of HPV vaccination with other interventions (e.g. reproductive health education; pre-marriage counseling activities); planning of post-implementation activities (strengthening cancer registry; enhancing cervical cancer screening); advocacy groups involvement. In both Morocco and Tunisia the disease burden is estimated through information generated from the cancer registry, as well as through special studies/surveys. NITAG members and decision-makers in both countries are convinced about the HPV vaccine effectiveness and there are no concerns about HPV vaccine acceptability. The Moroccan NITAG with the Ministry of Health has finalized the HPV vaccine introduction dossier which will be submitted shortly to the Ministry of Health and the Ministry of Finance. Morocco anticipates to introduce the HPV vaccine through the school health programme to 11 year old girls, in September 2019. 3.5. Need for operational research The need for operational research was discussed in the round table discussions and the group work. The group recommended that research studies are needed for the following: establish the baseline data on cervical cancer; genotype testing; costeffectiveness studies; HPV vaccine acceptability studies in healthcare workers and adolescents; post-implementation studies (satisfaction, coverage, incidence). Conducting qualitative research was recommended to develop a communication plan for succesfull introduction of the HPV vaccine. For example, Tunisia conducted a cost-effectiveness study of both screening and vaccination and demonstrated the importance of both interventions. Morocco did not perform a costeffectiveness study, as they used available international data, and decision-makers are convinced that cervical cancer control is among the public health priorities. The importance of collaboration, nationally and internationally, was recognised to advance the research agenda on cervical cancer, HPV vaccination and adolescent health. 3.6. Required support for HPV vaccine introduction Successful introduction of the HPV vaccine as part of a comprehensive cervical cancer strategy requires collaboration between the immunisation programme and multiple stakeholders within programmes and across programmes and sectors at different levels of the government. Close collaborations between cancer control, adolescent health, women’s health and/or sexual and reproductive health programmes can foster partnerships to support the introduction of the HPV vaccine. Ongoing communication among stakeholders before, during and after the introduction of the vaccine is essential to the success of the immunisation programme. Raising
Please cite this article as: C. Dochez, S. Al Awaidy, E. Mohsni et al., Strengthening national teams of experts to support HPV vaccine introduction in Eastern Mediterranean countries: Lessons learnt and recommendations from an international workshop, Vaccine, https://doi.org/10.1016/j.vaccine.2019.11.027
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awareness and collaborating with key stakeholders is fundamental to ensuring high HPV vaccination coverage and awareness of the need to strengthen cervical cancer screening programmes. Potential partners include both governmental and non-governmental organisations, private sector, First Ladies, professional associations, women’s group, etc. The group suggested that stakeholders support is required for: updating the recommendations; support for training; procurement; facilitation of implementation and lobbying for country agenda; evaluation of the national cancer registry. Countries with no cancer registry require support with its establishment. Financial and technical support is required for national cost-effectiveness studies. Some countries indicated the need for support with prioritization of which new vaccine(s) to introduce (PCV, hepatitis A, acellular pertussis, rotavirus, HPV vaccine). Middle-income countries are not benefitting from Gavi support and Gavi-transitioning countries will require support with sustainable financial planning for new vaccine introduction. Problems of inaccessibility and security are also an issue in some of the countries in the Region.
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5. Conclusion Background materials, presentations and meeting recommendations were made available through a password protected website to all participants, including those participants that had confirmed their participation, but were unable to attend the workshop due to visa challenges. A mailing list of the HPV workshop includes both participants that attended and participants unable to attend the workshop. The workshop brought together a cross-section of individuals representing the EPI, NITAGs and specialist areas such as microbiology, health economics and communication. This facilitated an engaging and informed conversation about the various types of information required in order to make a recommendation for introducing the HPV vaccine. The workshop increased the awareness of the need of data on burden of disease and the associated benefits of HPV vaccination in Eastern Mediterranean countries. The importance of collaboration between different programmes including: immunisation, adolescent health, school health, sexual and reproductive health and cancer control programmes was clearly emphasized.
4. Discussion and recommendations Declaration of Competing Interest HPV vaccination should be regarded as an important tool for developing and strengthening the adolescent immunisation programme and overall adolescent health services. Since the countries in the Eastern Mediterraenan Region differ in terms of disease burden, financial situation and accessibility, each country planning to introduce the HPV vaccine will need tailor-made support. The following recommendations were made based on the discussions after the country presentations, the round table discussions and the outcome of the group work. &
& & &
& &
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Development of a comprehensive plan of action taking into account the specificity of each country in order to reach the regional and global targets Advocacy for introduction of the HPV vaccine based on the disease burden Providing technical support to the respective NITAGs for selection of the appropiate vaccine Creating a task force at the Ministry of Health of the respective countries to enhance a strong coordination between EPI, school and adolescent health, reproductive health and noncommunicable diseases Development of an advocacy, communication and social mobilization plan customized as per the country needs Involvement of all community players, including private sectors, NGOs, women’s associations, religious and community leaders Establishment of a national cancer registry Development of a monitoring and evaluation plan for HPV vaccine introduction
To follow-up on the recommendations made, the organisers will engage themselves towards the following action points: (1) support a stronger country evidence-based decision-making process through improving NITAG functioning and assisting with generating the required evidence; (2) organize another sub-regional meeting, including the countries that could not participate in the current workshop; (3) collaboration with partners like UNICEF, especially for the development of a regional communication strategy as the HPV vaccine has unique features; (4) support countries with operational research as per their needs; and (5) continue to advocate for the introduction of the HPV vaccine at all levels.
The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: [Dr Dochez reports that the University of Antwerp receives educational grants from both the public and private sector to support the project NESI. Dr Al Awaidy, Dr Mohsni, Dr Fahmy and Prof Boukraoui have nothing to disclose]. Acknowledgements We sincerely thank MSD and GSK for the educational grants provided to the University of Antwerp. Sincere thanks are extended to the Governments of the following countries that have facilitated the participation of country delegates: Jordan, Morocco, Palestine, Somalia, Sudan, Tunisia, United Arab Emirates. Finally, we would like to thank all facilitators and speakers, and all country delegates for their active participation in the workshop. References [1] Bruni L, Albero G, Serrano B, Mena M, Gómez D, Muñoz J, Bosch FX, de Sanjosé S. ICO/IARC. Information Centre on HPV and Cancer (HPV Information Centre). Human Papillomavirus and Related Diseases in the World. Summary Report 22 January 2019. [Last accessed 15 February 2019]. [2] Walboomers JM, Jacobs MV, Manos MM, Bosch FX, Kummer JA, Shah KV, et al. Human papillomavirus is a necessary cause of invasive cervical cancer worldwide. J Pathol 1999;189(1):12–9. [3] World Health Organization. Human papillomavirus vaccines: WHO position paper, May 2017. Wkly Epidemiol Rec 2017;92(19):241–68. [4] De Martel C, Plummer M, Vignat J, Franceschi S. Worldwide burden of cancer attributable to HPV by site, country and HPV type. Int J Cancer 2017;141: 664–70. [5] International Agency for Research on Cancer. Globocan 2018. https://gco.iarc. fr/today/data/factsheets/cancers/23-Cervix-uteri-fact-sheet.pdf [Last accessed 19 March 2019]. [6] World Health Organization. Global Vaccine Action Plan. WHO 2013. http:// www.who.int/immunization/global_vaccine_action_plan/GVAP_doc_2011_ 2020/en/ [Last accessed 15 February 2019]. [7] Bruni L, Diaz M, Barronuevo-Rosas L, Herrero R, Bray F. Bosch FX, de Sanjosé S and Castellsagué. Global estimates of human papillomavirus vaccination coverage by region and income level: a pooled analysis. Lancet Global Health 2016;4:e453–63. [8] World Health Organization. https://www.who.int/immunization/en/ [Last accessed 22 February 2019]. [9] HPV Information Center. https://www.hpvcentre.net/datastatistics.php [Last accessed 19 March 2019].
Please cite this article as: C. Dochez, S. Al Awaidy, E. Mohsni et al., Strengthening national teams of experts to support HPV vaccine introduction in Eastern Mediterranean countries: Lessons learnt and recommendations from an international workshop, Vaccine, https://doi.org/10.1016/j.vaccine.2019.11.027
6
C. Dochez et al. / Vaccine xxx (xxxx) xxx
[10] Broutet N, Lehnertz N, Mehl G, Camach AV, Bloem P, Chandra-Mouli V, et al. Effective health interventiona for adolescents that could be integrated with human papillomavirus vaccination programmes. J Adolesc Health 2013;53:6–13. [11] Seoud M. Extended Middle East and North Africa: cervical cancer and human papillomavirus: can we make the case for prevention in the ‘‘relatively” low prevalence region?. Vaccine 2013;31S:vii–viii. [12] Gessner BD, Duclos P, DeRoeck D, Nelson EAS. Informing decision makers: Experience and process of 15 National Immunization Technical Advisory Groups. Vaccine 2010;28S:A1–5. [13] Adjagba A, MacDonald NE, Ortega-Pérez I, Duclos P, 2016 Global NITAG Network Meeting Participants. Strenghtening and sustainability of national
immunization technical advisory groups (NITAGs) globally: Lessons and recommendations from the founding meeting of the global NITAG network. Vaccine 2017; 35: 3007–3011. [14] NITAG Resource Center. http://www.nitag-resource.org/ [Last accessed 19 March 2019]. [15] Dochez C, Burnett R, Mbola Mbassi S, Were F, Musyoke A, Trovoada D, et al. Improving skills and institutional capacity to strengthen adolescent immunisation programmes and health systmes in African countries through HPV vaccine introduction. Papillomavirus Res 2017;4:66–71.
Please cite this article as: C. Dochez, S. Al Awaidy, E. Mohsni et al., Strengthening national teams of experts to support HPV vaccine introduction in Eastern Mediterranean countries: Lessons learnt and recommendations from an international workshop, Vaccine, https://doi.org/10.1016/j.vaccine.2019.11.027
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Vaccine journal homepage: www.elsevier.com/locate/vaccine
Strengthening national teams of experts to support HPV vaccine introduction in Eastern Mediterranean countries: Lessons learnt and recommendations from an international workshop Carine Dochez a,⇑, Salah Al Awaidy b, Ezzeddine Mohsni c, Kamal Fahmy d, Mohammed Bouskraoui e a
Network for Education and Support in Immunisation (NESI). Department Epidemiology and Social Medicine. University of Antwerp. Universiteitsplein 1. 2610 Antwerp, Belgium Ministry of Health, Oman Global Health Development/Eastern Mediterranean Public Health Network (GHD/EMPHNET), Jordan d World Health Organization/Regional Office for the Eastern Mediterranean (WHO/EMRO), Egypt e University Cadi Ayyad & Société Marocaine d’Infectiologie Pédiatrique et de Vaccinologie (SOMIPEV), Morocco b c
a r t i c l e
i n f o
Article history: Received 25 April 2019 Received in revised form 11 November 2019 Accepted 12 November 2019 Available online xxxx Keywords: Cervical cancer HPV vaccines Eastern Mediterranean Region NITAGs
a b s t r a c t Several countries have started to introduce the HPV vaccine into their national immunisation programme, with the majority of these countries being high or upper-middle income countries. Currently, 91 countries have introduced the HPV vaccine globally. One of the regions lagging behind in the introduction of the HPV vaccine is the Eastern Mediterranean Region, with currently only Libya and the United Arab Emirates having introduced the HPV vaccine. In order to support countries in the Eastern Mediterranean Region with their decision-making process for HPV vaccine introduction, a regional workshop was organised to explore the current status of HPV vaccine introduction plans in the Eastern Mediterranean countries, gaps in information about HPV disease burden in the region and the need for quality HPV data to make an informed decision to introduce the HPV vaccine, socio-cultural and religious challenges with HPV vaccine introduction, and the role of NITAGs in formulating recommendations for HPV vaccine introduction. Participating countries reflected on their respective status of decision making process about HPV vaccine introduction; they discussed any needs for operational research to support the decision-making process; and highlighed technical and financial support that might be required from partners to assist with HPV vaccine introduction. Recommendations were made on how to advance the decision-making process for HPV vaccine introduction. The workshop increased the awareness of the need of data on burden of disease and the associated benefits of HPV vaccination in Eastern Mediterranean countries. The importance of collaboration between different programmes including: immunisation, adolescent health, school health, sexual and reproductive health and cancer control programmes was clearly emphasized. Ó 2019 Elsevier Ltd. All rights reserved.
1. Introduction and rationale for the workshop Cervical cancer is an important public health problem and is the third leading cause of female cancer in the world [1]. The link between cervical cancer and a persistent infection with high-risk or oncogenic human papillomaviruses (HPV) has been clearly established [2]. Each year, cervical cancer is responsible for around 560,000 new cases and 300,000 deaths worldwide, with the highest burden occurring in low-income countries [1]. Oncogenic HPV types 16 and 18 are responsible for about 70% of cervical cancer ⇑ Corresponding author. E-mail address: [email protected] (C. Dochez).
cases. Non-oncogenic HPV types, like HPV 6 and 11, are responsible for the majority of genital warts [3,4]. In the Eastern Mediterranean Region (EMR), the incidence rates varies between countries. For example, in Djibouti the standardised incidence rate is 13.3/100,000 population, which is close to the global incidence rate of 13.1/100,000 population; while the standardised mortality rate of 10.6/100,000 population is higher than the global mortality rate of 6.9/100,000 population. Morocco has a higher incidence rate of 17.2/100,000 population and a mortality rate of 12.6/100,000. Oman and Bahrain for example have a lower incidence rate of respectively 6.3/100,000 and 3.8/100,000 population, and a mortality rate of repectively 3.9/100,000 and 2.7/100,000 population [1,5].
https://doi.org/10.1016/j.vaccine.2019.11.027 0264-410X/Ó 2019 Elsevier Ltd. All rights reserved.
Please cite this article as: C. Dochez, S. Al Awaidy, E. Mohsni et al., Strengthening national teams of experts to support HPV vaccine introduction in Eastern Mediterranean countries: Lessons learnt and recommendations from an international workshop, Vaccine, https://doi.org/10.1016/j.vaccine.2019.11.027
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HPV vaccines have an enormous potential in the prevention of cervical cancer. Three efficacious and safe HPV vaccines are currently available: the bivalent, quadrivalent and ninevalent vaccine. The vaccines are based on virus-like particles (VLPs). The bivalent vaccine contains VLP antigens for HPV 16/18. The quadrivalent vaccine contains VLP antigens for HPV 6/11/16/18. Evidence exists that both the bivalent and quadrivalent HPV vaccines show cross-reactivity to genotypes not included in the vaccines, especially to HPV 31/33/45 for the bivalent vaccine, and HPV 31 for the quadrivalent vaccine [3]. The ninevalent vaccine contains VLP antigens for HPV 6/11/16/18/31/33/45/52/58 [3]. As HPV can also cause other cancers, like vulvar, anal, penile and oropharyngeal cancer, the vaccines have potential to prevent those cancers as well. The quadrivalent and ninevalent vaccines protect also against genital warts caused by the non-oncogenic HPV types 6 and 11 [3]. All HPV vaccines were originally licensed in a three-dose schedule over a 6 months time period, given as an intramuscular injection to 9–14 year old girls. Currently, WHO recommends a two-dose schedule for 9–14 year olds. The three-dose schedule remains valid for individuals above 15 years of age and for immuno-compromised individuals. These recommendations apply to the three HPV vaccines [3]. Introduction of new vaccines into national immunisation programmes is one of the goals outlined in the Decade of Vaccines (2011–2020) [6]. Several countries have started to introduce the HPV vaccine into their national immunisation programme, with the majority of these countries being high or upper-middle income countries [7]. Currently, 91 countries have introduced the HPV vaccine globally [8]. One of the regions lagging behind in the introduction of the HPV vaccine is the Eastern Mediterranean Region, with currently only Libya and the United Arab Emirates (UAE) having introduced the HPV vaccine [9]. Around 1.2 billion people are aged between 10 and 19 years, i.e. 1 in 6 persons globally is an adolescent. Protecting adolescents now from potential health risks later in adulthood is important and the HPV vaccine provides this opportunity for the prevention of HPV related cancers [10]. Being a vaccine targeting adolescents, any HPV vaccination programme might face some potential public health challenges: (1) a strong adolescent health or school-based vaccination programme need to be in place to successfully deliver the HPV vaccine; (2) the involvement of multiple authorities at country level (Ministry of Health and Ministry of Education); (3) addressing sociobehavioural issues (e.g. gender issues as girls are being targeted, parental consent, potential stigma of HPV being a sexually transmitted infection); and (4) a delay in demonstrating health benefits as cervical cancer takes many decades to develop. As informed earlier, in the Eastern Mediterranean Region the cervical cancer incidence rates vary between countries, with the highest incidence rate observed in Somalia (24/100,000 population) and the lowest in Iraq (1.9/100,000 population) [1,5]. However, several countries in the region lack a national cancer registry, therefore, the exact scale of cervical cancer is difficult to estimate. Several countries provide opportunistic screening, but patients often present with cervical cancer in a late stage with low survival rates [11]. Before starting the introduction of a new vaccine, countries need to make an evidence-based decision whether a new vaccine merits introduction into the national immunisation programme. As more and more new vaccines become available, countries face several challenges in introducing these vaccines in the existing immunisation programme: (a) decision-making and prioritisation of which vaccine(s) to be introduced; (b) addressing strengths and weaknesses in the immunisation programme; (c) managing more complicated vaccination schedules; (d) developing multi-year plans to ensure sustainable use of the new vaccines.
National Immunisation Technical Advisory Groups (NITAGs) are tasked to provide an independent, evidence-based recommendation to their governments [12,13]. Except for Somalia, all countries in the Eastern Mediterranean region, have established a NITAG, though not all are fully functional [14]. 1.1. Objectives of the workshop In order to support countries in the decision-making process for HPV vaccine introduction, a workshop on ‘‘Strengthening national teams of experts to support HPV vaccine introduction in Eastern Mediterranean countries” was organised from 14 to 16 October 2018 in Marrakech, Morocco, by the University Cadi Ayyad, Société Marocaine d’Infectiologie Pédiatrique et de Vaccinologie (SOMIPEV), and the Network for Education and Support in Immunisation (NESI)/University of Antwerp. The workshop received support from the Eastern Mediterranean Regional Office of the World Health Organisation (WHO/EMRO), Global Health Development/Eastern Mediterranean Public Health Network (GHD/EMPHNET) and the Ministry of Health of Oman. Similar workshops have been organised for the Eastern and Southern African Region, which greatly supported the countries with their decision-making process for HPV vaccine introduction [15]. The key target audience included representatives of Ministry of Health (Expanded Programme on Immunisation; Adolescent Health Programme; Non-communicable Disease Programme; School Health Programme), chairs and members of the National Immunisation Technical Advisory Groups (NITAGs), national and international immunisation partners, and other relevant stakeholders. The objectives of the workshop included: (1) To discuss the burden of HPV related diseases, especially cervical cancer, in the Eastern Mediterranean Region; (2) To discuss the available HPV vaccines and their use in national immunisation programmes; (3) To discuss potential adolescent health interventions to be delivered alongside HPV vaccination; (4) To discuss optimal communication strategies for the introduction of HPV vaccination; (5) To exchange lessons learnt and best practices regarding new vaccine introduction, especially HPV vaccine, and adolescent health services among participating countries; (6) To strengthen national teams of experts in the participating countries to make evidence-based recommendations and decisions to support and advocate for the introduction of HPV vaccination; and (7) To strengthen the international community to further stimulate discussion and research on cervical cancer, HPV vaccination and adolescent health. A total of 57 delegates participated in the workshop. From each country the NITAG chair (or member) and 2 Ministry of Health representatives were invited. Nominated delegates that attended the workshop were from the Ministry of Health and/or NITAG members from the following countries: Jordan, Morocco, Palestine, Somalia, Sudan, Tunisia, United Arab Emirates. Nominees from Afghanistan, Djibouti, Iraq, Pakistan, Syria, Saudi Arabia had confirmed their participation, but due to visa related problems were not able to attend. The organisers have tried to set up a WebEx connection for remote participation, but the signal at the venue was not strong enough to support this. Other participants came from academia, national and international organisations, International Islamic Fiqh Academy, Islamic Development Bank, and industry. Facilitators were from: Cadi Ayyad University, SOMIPEV, GHD/EMPHNET, Ministry of Health Oman, WHO/EMRO, IARC/ WHO, London School of Hygiene and Tropical Medicine, Gavi, WHO/Morocco and NESI/University of Antwerp. 2. Activities The workshop explored the current status of HPV vaccine introduction plans in Eastern Mediterranean countries, gaps in
Please cite this article as: C. Dochez, S. Al Awaidy, E. Mohsni et al., Strengthening national teams of experts to support HPV vaccine introduction in Eastern Mediterranean countries: Lessons learnt and recommendations from an international workshop, Vaccine, https://doi.org/10.1016/j.vaccine.2019.11.027
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information about HPV disease burden in the region, and the role of NITAGs in new vaccine introduction. The workshop comprised of interactive presentations, round table discussions, country presentations, including sharing of experiences and best practices, and group work. Prior to the workshop, country delegates were provided with a PowerPoint template to prepare for their respective country presentation.
Table 1 Current status of HPV vaccine introduction in the participating countries from the Eastern Mediterranean Region.
2.2. Day 2: Communication, advocacy, and socio-cultural and religious challenges The second day of the workshop focused on communication and building public trust for HPV vaccination. The plenary presentations were followed by a first round table discussion on ‘‘Overcoming hurdles for HPV vaccine introduction and cervical cancer screening, focusing on socio-cultural and religious challenges”. Experiences of HPV vaccine introduction from other regions were shared by delegates from Indonesia and Senegal. 2.3. Day 3: HPV data and country decision-making The last day started with a second round table discussion, focusing on ‘‘HPV data required to make an evidence-based decision to introduce HPV vaccine; and monitoring HPV vaccination coverage”. During the final session of the workshop, group work was conducted, addressing the following issues: (a) Status of decision-making about HPV vaccine introduction in the participating countries; (b) Any needs for operational research to support the decision-making; (c) Technical and financial support that might be required from partners. Recommendations were made on how to advance the decision-making process for HPV vaccine introduction in the participating countries. 3. Results: Observations and recommendations from the workshop The results section highlights observations and discussions during the workshop. Table 1 summarizes the current status of HPV vaccine introduction in the countries that participated in the workshop. Only UAE has introduced the HPV vaccine. Morocco has concrete plans for HPV vaccine introduction in 2019, if finances are available. The other countries have no concrete plans, as of the date of the workshop, for HPV vaccine introduction. Reasons formulated include: lack of disease data; lack of cancer registry; competing priorities; high costs of the vaccine if the country is not Gavieligible. For example, Tunisia clearly mentioned competing priorities with other vaccines, like pneumococcal conjugate vaccine, hepatitis A vaccine, acellular pertussis and rotavirus vaccine. Morocco had made the decision to introduce the HPV vaccine several years ago, but lack of availability of funds delayed the introduction. 3.1. Importance of the HPV vaccine Key aspects on burden of disease, cervical cancer screening, update on HPV vaccines and cost-effectiveness, and delivery
Status of HPV vaccine introduction*
Jordan Morocco
No current plan for HPV vaccine introduction National HPV vaccine introduction planned for September 2019 No current plan for HPV vaccine introduction No current plan for HPV vaccine introduction No current plan for HPV vaccine introduction No current plan for HPV vaccine introduction HPV vaccine has been introduced: sub-national HPV vaccine introduction in Abu Dhabi in 2008; national introduction in 2018
Palestine Somalia Sudan Tunisia United Arab Emirates
2.1. Day 1: Updates on cervical cancer and HPV vaccines Presentations highlighted key aspects on burden of disease, cervical cancer screening, update on HPV vaccines and costeffectiveness, delivery platform for HPV vaccination, and potential integration with other adolescent health interventions. The role of the NITAGs in the decision-making process for HPV vaccine introduction was thoroughly discussed.
Country
*
At the time of the workshop (October 2018).
platform for HPV vaccination were highlighted. A recap on the virology of the virus, burden of disease caused by HPV and risk factors adding to the development of cervical cancer were discussed. A sero-prevalence study, that has recently started in Morocco, was presented, emphasizing the usefulness of epidemiological studies before the introduction of the vaccine, as well as during the vaccination programme. The characteristics of the different available HPV vaccines were discussed in detail. Programme managers are tasked to evaluate the different options available against programme needs and costs before introducing the HPV vaccine. The introduction of a new vaccine is also an opportunity to reinforce routine immunisation and strenghtening other EPI essentials, as a review of the current immunisation programme is opportune before introducing the new vaccine: e.g. is there full benefit with currently introduced vaccines (high coverage, limited drop-out rate); is the cold chain functional (vaccine storage, monitoring use and wastage); staff training; monitoring immunisation coverage; monitoring adverse events following immunisation (AEFI); is there a disease surveillance system in place.
3.2. Addressing implementation challenges A global overview was given of the countries that have currently introduced the HPV vaccine. The HPV vaccine is special compared to other EPI vaccines given its age of introduction and the target population, i.e. girls of 9–14 year of age. Could this (partially) explain the low uptake of HPV vaccination programmes in the Eastern Mediterranean Region? The main hurdles for HPV vaccine introduction were discussed during the round table discussions and group work.
3.2.1. Advocacy, communication and social mobilization Advocating for the introduction of the HPV vaccine is of outmost importance, reflecting the need of the HPV vaccine being included in the routine immunisation programme. Increasing community awareness through comprehensive, timely and appropriate communication is fundamental to the successful and sustainable introduction of the HPV vaccine. Communication is a key element of any successful public health programme, and investing in communication for the HPV vaccine is particularly important because of its unique features that were highlighted in the previous section. From hesitation to complete refusal, vaccine oppositions represent an obstacle to the prevention of infectious diseases. The refusal of vaccinations can be due to the fear of adverse events, fear maintained by media crises, false information on the Internet and in the media, anti-vaccine movements and various beliefs. The concept of benefit/risk is reversed at the expense of vaccines, and the search for collective benefit is becoming scarce.
Please cite this article as: C. Dochez, S. Al Awaidy, E. Mohsni et al., Strengthening national teams of experts to support HPV vaccine introduction in Eastern Mediterranean countries: Lessons learnt and recommendations from an international workshop, Vaccine, https://doi.org/10.1016/j.vaccine.2019.11.027
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The role of the healthcare professional is essential, but providing information to caregivers and patients requires sufficient time. The current influence of the media and the Internet justifies an international reflection to fight against the nuisance of nonscientific and erroneous information. Vaccine hesitancy has always existed and seems inevitable. However, some polemics can and should be anticipated. We must learn to cope better, especially by using the same weapons as the opponents of vaccination. Communication is a key element of any successful public health programme, and investing in communication for the HPV vaccine is particularly important because of its unique features. Preparation of a strong communication plan before the start of the HPV vaccination programme, as well as a crisis management plan, will ensure the succesfull introduction of the HPV vaccine and to achieve high coverage. 3.2.2. Socio-cultural and religious challenges Socio-cultural and religious challenges need to be taken into account before the introduction of the HPV vaccine. Issues that need to be addresses include gender issues: will only girls be vaccinated and how to discuss this with the general public without creating a negative attitude towards vaccinating girls only. The discussion should also include communication to avoid the potential stigma of HPV being a sexually transmitted infection. The issue of parental consent needs to be addressed. Involvement of all community players, including private sectors, NGOs, women associations, religious and community leaders, is of outmost importance for the successful introduction of the HPV vaccine. 3.2.3. Integration with other adolescent health interventions Few interventions are aimed at adolescents and those that exist do not always reach them. This is because adolescents generally have little contact with the health system. Several health interventions may be proposed at the same time as HPV vaccination and promote synergies between the EPI and school health and/or adolescent health programmes. However, it was observed that the progress with the integration agenda is too little. Workshop participants proposed integration of HPV vaccination with other interventions like reproductive health education and premarriage counseling activities. Before implementing school-based vaccination programmes, countries must be able to assess the capacity, strengths and weaknesses of their education and health systems to support these programmes. School-based immunisation strategies are an opportunity to collaborate with school health programmes when they exist and, more broadly, with the Ministry of Education, to incorporate public health messages into schools. 3.3. The importance of quality HPV data A current study on sero-prevalence in Morocco emphasized the usefulness of epidemiological studies before the start of the HPV vaccination programme, as well as during the vaccination programme. All countries should have a national cancer registry in place, to keep cancer data records in the population in order to measure the burden of disease in communities and to assess the impact of interventions. Workshop participants also recommended that the health information system needs to be strengthened. 3.4. Decision-making process The role of the NITAGs in the decision-making process for HPV vaccine introduction was stressed. To be successful, new vaccine introduction should follow a rational process and different steps
should be considered as part of decision-making: (1) what is the burden of disease to be prevented in terms of morbidity and mortality; (2) is there a good intervention, i.e. is the vaccine efficacious and effective, safe and acceptable for the target population; (3) what is the cost of the new vaccine and of its implementation and what is its comparative effectiveness with other vaccines/ interventions in terms of health gains. Based on the above, a decision can be taken that a new vaccine merits introduction as a public health priority. Before a final decision on introduction of a new vaccine, two other steps are of major importance: (1) are sustainable finances available to pay for the new vaccine; and (2) what are the programmatic implications. Workshop participants emphasized that the decision-making process should include: e.g. pricing issues in low and middleincome countries; prioritization of different vaccines; selecting the HPV vaccine best suited to the country needs; development of implementation plan; integration of HPV vaccination with other interventions (e.g. reproductive health education; pre-marriage counseling activities); planning of post-implementation activities (strengthening cancer registry; enhancing cervical cancer screening); advocacy groups involvement. In both Morocco and Tunisia the disease burden is estimated through information generated from the cancer registry, as well as through special studies/surveys. NITAG members and decision-makers in both countries are convinced about the HPV vaccine effectiveness and there are no concerns about HPV vaccine acceptability. The Moroccan NITAG with the Ministry of Health has finalized the HPV vaccine introduction dossier which will be submitted shortly to the Ministry of Health and the Ministry of Finance. Morocco anticipates to introduce the HPV vaccine through the school health programme to 11 year old girls, in September 2019. 3.5. Need for operational research The need for operational research was discussed in the round table discussions and the group work. The group recommended that research studies are needed for the following: establish the baseline data on cervical cancer; genotype testing; costeffectiveness studies; HPV vaccine acceptability studies in healthcare workers and adolescents; post-implementation studies (satisfaction, coverage, incidence). Conducting qualitative research was recommended to develop a communication plan for succesfull introduction of the HPV vaccine. For example, Tunisia conducted a cost-effectiveness study of both screening and vaccination and demonstrated the importance of both interventions. Morocco did not perform a costeffectiveness study, as they used available international data, and decision-makers are convinced that cervical cancer control is among the public health priorities. The importance of collaboration, nationally and internationally, was recognised to advance the research agenda on cervical cancer, HPV vaccination and adolescent health. 3.6. Required support for HPV vaccine introduction Successful introduction of the HPV vaccine as part of a comprehensive cervical cancer strategy requires collaboration between the immunisation programme and multiple stakeholders within programmes and across programmes and sectors at different levels of the government. Close collaborations between cancer control, adolescent health, women’s health and/or sexual and reproductive health programmes can foster partnerships to support the introduction of the HPV vaccine. Ongoing communication among stakeholders before, during and after the introduction of the vaccine is essential to the success of the immunisation programme. Raising
Please cite this article as: C. Dochez, S. Al Awaidy, E. Mohsni et al., Strengthening national teams of experts to support HPV vaccine introduction in Eastern Mediterranean countries: Lessons learnt and recommendations from an international workshop, Vaccine, https://doi.org/10.1016/j.vaccine.2019.11.027
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awareness and collaborating with key stakeholders is fundamental to ensuring high HPV vaccination coverage and awareness of the need to strengthen cervical cancer screening programmes. Potential partners include both governmental and non-governmental organisations, private sector, First Ladies, professional associations, women’s group, etc. The group suggested that stakeholders support is required for: updating the recommendations; support for training; procurement; facilitation of implementation and lobbying for country agenda; evaluation of the national cancer registry. Countries with no cancer registry require support with its establishment. Financial and technical support is required for national cost-effectiveness studies. Some countries indicated the need for support with prioritization of which new vaccine(s) to introduce (PCV, hepatitis A, acellular pertussis, rotavirus, HPV vaccine). Middle-income countries are not benefitting from Gavi support and Gavi-transitioning countries will require support with sustainable financial planning for new vaccine introduction. Problems of inaccessibility and security are also an issue in some of the countries in the Region.
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5. Conclusion Background materials, presentations and meeting recommendations were made available through a password protected website to all participants, including those participants that had confirmed their participation, but were unable to attend the workshop due to visa challenges. A mailing list of the HPV workshop includes both participants that attended and participants unable to attend the workshop. The workshop brought together a cross-section of individuals representing the EPI, NITAGs and specialist areas such as microbiology, health economics and communication. This facilitated an engaging and informed conversation about the various types of information required in order to make a recommendation for introducing the HPV vaccine. The workshop increased the awareness of the need of data on burden of disease and the associated benefits of HPV vaccination in Eastern Mediterranean countries. The importance of collaboration between different programmes including: immunisation, adolescent health, school health, sexual and reproductive health and cancer control programmes was clearly emphasized.
4. Discussion and recommendations Declaration of Competing Interest HPV vaccination should be regarded as an important tool for developing and strengthening the adolescent immunisation programme and overall adolescent health services. Since the countries in the Eastern Mediterraenan Region differ in terms of disease burden, financial situation and accessibility, each country planning to introduce the HPV vaccine will need tailor-made support. The following recommendations were made based on the discussions after the country presentations, the round table discussions and the outcome of the group work. &
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Development of a comprehensive plan of action taking into account the specificity of each country in order to reach the regional and global targets Advocacy for introduction of the HPV vaccine based on the disease burden Providing technical support to the respective NITAGs for selection of the appropiate vaccine Creating a task force at the Ministry of Health of the respective countries to enhance a strong coordination between EPI, school and adolescent health, reproductive health and noncommunicable diseases Development of an advocacy, communication and social mobilization plan customized as per the country needs Involvement of all community players, including private sectors, NGOs, women’s associations, religious and community leaders Establishment of a national cancer registry Development of a monitoring and evaluation plan for HPV vaccine introduction
To follow-up on the recommendations made, the organisers will engage themselves towards the following action points: (1) support a stronger country evidence-based decision-making process through improving NITAG functioning and assisting with generating the required evidence; (2) organize another sub-regional meeting, including the countries that could not participate in the current workshop; (3) collaboration with partners like UNICEF, especially for the development of a regional communication strategy as the HPV vaccine has unique features; (4) support countries with operational research as per their needs; and (5) continue to advocate for the introduction of the HPV vaccine at all levels.
The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: [Dr Dochez reports that the University of Antwerp receives educational grants from both the public and private sector to support the project NESI. Dr Al Awaidy, Dr Mohsni, Dr Fahmy and Prof Boukraoui have nothing to disclose]. Acknowledgements We sincerely thank MSD and GSK for the educational grants provided to the University of Antwerp. Sincere thanks are extended to the Governments of the following countries that have facilitated the participation of country delegates: Jordan, Morocco, Palestine, Somalia, Sudan, Tunisia, United Arab Emirates. Finally, we would like to thank all facilitators and speakers, and all country delegates for their active participation in the workshop. References [1] Bruni L, Albero G, Serrano B, Mena M, Gómez D, Muñoz J, Bosch FX, de Sanjosé S. ICO/IARC. Information Centre on HPV and Cancer (HPV Information Centre). Human Papillomavirus and Related Diseases in the World. Summary Report 22 January 2019. [Last accessed 15 February 2019]. [2] Walboomers JM, Jacobs MV, Manos MM, Bosch FX, Kummer JA, Shah KV, et al. Human papillomavirus is a necessary cause of invasive cervical cancer worldwide. J Pathol 1999;189(1):12–9. [3] World Health Organization. Human papillomavirus vaccines: WHO position paper, May 2017. Wkly Epidemiol Rec 2017;92(19):241–68. [4] De Martel C, Plummer M, Vignat J, Franceschi S. Worldwide burden of cancer attributable to HPV by site, country and HPV type. Int J Cancer 2017;141: 664–70. [5] International Agency for Research on Cancer. Globocan 2018. https://gco.iarc. fr/today/data/factsheets/cancers/23-Cervix-uteri-fact-sheet.pdf [Last accessed 19 March 2019]. [6] World Health Organization. Global Vaccine Action Plan. WHO 2013. http:// www.who.int/immunization/global_vaccine_action_plan/GVAP_doc_2011_ 2020/en/ [Last accessed 15 February 2019]. [7] Bruni L, Diaz M, Barronuevo-Rosas L, Herrero R, Bray F. Bosch FX, de Sanjosé S and Castellsagué. Global estimates of human papillomavirus vaccination coverage by region and income level: a pooled analysis. Lancet Global Health 2016;4:e453–63. [8] World Health Organization. https://www.who.int/immunization/en/ [Last accessed 22 February 2019]. [9] HPV Information Center. https://www.hpvcentre.net/datastatistics.php [Last accessed 19 March 2019].
Please cite this article as: C. Dochez, S. Al Awaidy, E. Mohsni et al., Strengthening national teams of experts to support HPV vaccine introduction in Eastern Mediterranean countries: Lessons learnt and recommendations from an international workshop, Vaccine, https://doi.org/10.1016/j.vaccine.2019.11.027
6
C. Dochez et al. / Vaccine xxx (xxxx) xxx
[10] Broutet N, Lehnertz N, Mehl G, Camach AV, Bloem P, Chandra-Mouli V, et al. Effective health interventiona for adolescents that could be integrated with human papillomavirus vaccination programmes. J Adolesc Health 2013;53:6–13. [11] Seoud M. Extended Middle East and North Africa: cervical cancer and human papillomavirus: can we make the case for prevention in the ‘‘relatively” low prevalence region?. Vaccine 2013;31S:vii–viii. [12] Gessner BD, Duclos P, DeRoeck D, Nelson EAS. Informing decision makers: Experience and process of 15 National Immunization Technical Advisory Groups. Vaccine 2010;28S:A1–5. [13] Adjagba A, MacDonald NE, Ortega-Pérez I, Duclos P, 2016 Global NITAG Network Meeting Participants. Strenghtening and sustainability of national
immunization technical advisory groups (NITAGs) globally: Lessons and recommendations from the founding meeting of the global NITAG network. Vaccine 2017; 35: 3007–3011. [14] NITAG Resource Center. http://www.nitag-resource.org/ [Last accessed 19 March 2019]. [15] Dochez C, Burnett R, Mbola Mbassi S, Were F, Musyoke A, Trovoada D, et al. Improving skills and institutional capacity to strengthen adolescent immunisation programmes and health systmes in African countries through HPV vaccine introduction. Papillomavirus Res 2017;4:66–71.
Please cite this article as: C. Dochez, S. Al Awaidy, E. Mohsni et al., Strengthening national teams of experts to support HPV vaccine introduction in Eastern Mediterranean countries: Lessons learnt and recommendations from an international workshop, Vaccine, https://doi.org/10.1016/j.vaccine.2019.11.027