GVSI Bulletin GVSI Bulletin - World Health Organization

GVSI Bulletin January 2015

7th edition

AEFI investigation field simulation training – Trainees at a residence Sahafa, Khartoum

About this newsletter Providing updates on GVSI activities Contents GACVS

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Innovation - India

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Innovation - EMRO

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Managing Crisis

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AFRO Activities

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The GVSI Bulletin1 newsletter provides updates on the implementation of the Global Vaccine Safety Initiative (GVSI)2, a forum aiming to synergize the knowledge and expertise of its stakeholders to help ensure the safety of vaccinations through the implementation of the three strategic goals of the Global Vaccine Safety Blueprint3 To optimize collaborative activities, the GVSI Bulletin aims to provide all stakeholders of the Initiative with a practical overview of activities identified. Components of the portfolio4 and activities of GVSI stakeholders that match the eight objectives of the Global Vaccine Safety Blue print and profiles of stakeholders are presented to increase visibility of actions and support synergies.

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http://www.who.int/vaccine_safety/news/GVSI_News/en/index.html http://www.who.int/vaccine_safety/initiative/en/ 3 http://www.vaccine-safety-training.org/tl_files/vs/pdf/WHO_IVB_12.07_eng.pdf 4 http://www.who.int/vaccine_safety/initiative/GVSI_portfolio_directory_1_July_2014.pdf?ua=1 2

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Highlights of the 31st meeting of the Global Advisory Committee on Vaccine Safety (GACVS) Geneva, December 2014


Patrick Zuber1

GACVS members during the December 2014 meeting in WHO Geneva.

GACVS has been regularly meeting in June and December for over 15 years in order to address safety concerns of global importance and provide evidence-based advice. GACVS recommendations are instrumental in managing risk-benefit of vaccination strategies and are being used by global, regional and national immunization advisory bodies. Over the time the work of the committee has evolved from visiting safety issues related to the vaccines that were part of the early Expanded Program on Immunization to anticipating the introduction of important new products and regularly updating their safety profile through periodic reviews. GACVS also provides expert advice to WHO and its partners in the development of new tools and methods, such as those being disseminated through the Global Vaccine Safety Initiative. In addition, GACVS is part of the WHO’s vaccine safety alert and response mechanism and can convey at short notice if required based on established procedures. During its latest meeting, GACVS has discussed currently available data about the safety of promising vaccine products against malaria, dengue and Ebola virus diseases. The committee is also supporting the preparation of guidance documents that will help setup safety surveillance when those products are implemented through national programs. On the methodological front, GACVS proposed indicators for performance of vaccine safety surveillance systems. It is also reviewing criteria for assessing web sites content through the Vaccine Safety Net and advises on harmonized methodologies for monitoring the safety of vaccines used during pregnancy. The meeting report will be available in WHO’s Weekly Epidemiological Record on 23 January 2015. 1

Safety and Vigilance (SAV), Department of Essential Medicines and Health Products, World Health Organization, Geneva.

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The Antenatal and Infant Monitoring System: Promoting AEFI Reporting in Difficult Environments An innovative approach using interactive voice response (IVR) technology


Sharon Pandian1 and Gagandeep Kang1 The Antenatal and Infant Monitoring system (AIM) is an initiative started by the Christian Medical College, Vellore, India in collaboration with the Indian Institute of Technology Madras, the Rural Technology Business Incubator and Uniphore, a data and voice solutions software company. AIM uses interactive voice response (IVR) technology to provide contact with and support for pregnant women in the antenatal period and then monitor vaccination, infant wellbeing and the occurrence of adverse events following immunization, with information being provided directly by the mother. In India, with a large population and significant resource limitations, it is challenging to establish well organized systems for data collection. There are about 920 million mobile phone users in India with about 75% population coverage. Mobile phones are easy to carry and do not require high skills or literacy to operate. They help circumvent the communication barrier particularly for women in rural communities providing a sense of independence and accessibility in emergencies. The AIM project has been initiated as a pilot in two areas in Vellore, Tamil Nadu- an urban area, Kaspa with 500 mothers and a rural area, Kathalampet, with 300 mothers. After considerable testing, refinement and re-deployment, the IVR system has been designed as a user friendly system in the local language, Tamil. How it works AIM works establishing a relationship with pregnant women by sending bi-weekly voice messages through their mobile phones in the antenatal period and also by asking simple questions by a voice recording system. In the postnatal period women receive information on vaccines and due dates for vaccination and the questions now relate to the wellbeing of the child and reporting of any possible adverse effects following immunization (AEFI). The automated calls with appropriately designed messages will go to a pregnant woman according to the stage of pregnancy or to the mother according to the age of her child. The messages have been personalised where possible and there is ongoing work 1

Christian Medical College and Hospital, Vellore. India.

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towards further improvement.


The reason behind recruiting pregnant women is to progressively develop a spontaneous reporting system that will complement and augment the national AEFI reporting system. The women benefit from the messages regarding pregnancy and a safe delivery and learn to answer simple IVR questions, so they can answer AEFI capture questions later on. The IVR system also helps monitor high risk mothers with high blood pressure, gestational diabetes or other complications. The feedback from the mothers using the system in the antenatal period is heartening. In the post natal period, messages on the beneficial effects of breast feeding, nutritional food for mothers, preparing supplementary food for babies, stimulating the baby’s physical and mental growth, maintaining personal health and hygiene and vaccination reminders are sent. The vaccination reminders and the adverse event capture if any, are planned to be integrated into the routine reporting system of the national immunization program. The system calls the mother 24 hours before the scheduled immunisation assigned by the government health centre and reminds her of the vaccine due for the child. There is a 2 week window to accommodate late immunisation for various reasons like low birth weight, or the child being sick or the unavailability of personnel or vaccine in the health centre, with the reminder sent out every week. A day after every reminder, an automated voice recorded monitoring call enquires from the mother if her child was immunised. If the mother reports an immunization, she is given an option to report any of the adverse effects from a list, or record a brief statement about an adverse effect which is not on the list. When any AEFI is reported, a SMS alert and a flashing alert on the webpage immediately goes to a doctor and an administrator who follow it up. Apart from the 24 hour and 7 day capture, there is also an option for the mother to make a call from Kaspa-Vasanthapuram Zero her phone to our server where she can report any Balance Above AEFI. Once the administrator has followed up with 8% Rs.10 the mother on the AEFI reported, the issue is moved 27% from the alert screen. So far, in 4 months of operation, the system has captured 10 AEFIs, most of which were related to immunization, these were Enough for missed call investigated and ranged from mild rash to seizures. Above Rs.5 12%

39%

Minimum Rs.5 14%

Kathalampet Zero Balance 11%

Above Rs.10 46%

Enough For Missed Call 18%

Above Rs.5 9%

Minimum Rs.5 16%

Pregnant women and mothers need not have a sophisticated handset or even a phone of their own to benefit from this system. They could use their husband’s, father’s or even a friend’s phone to receive the calls. The system has also been designed to capture convenient times for a mother to receive calls and options for her to change phone numbers, register herself or a friend for the service or terminate the services for personal reasons. From our survey, we gathered that many women have at least some balance money on their phone to give a missed call which is sufficient for our system to work (Fig 1). The system requires very basic inputs from mothers. However, some illiterate mothers find it

Fig 1: Balance of money available to mothers at two pilot sites to make phone calls 4


challenging. This is in contrast to mothers who are educated beyond the fifth grade who seem comfortable with the system. Mothers’ feedback on the messages have been used to structure delivery of information that reinforces health promotion and provides access to reporting systems and if needed, emergency response. Evaluations show that as problems of timing and type of message are progressively ironed out, the IVRS is now being viewed as a valued addition to the antenatal and perinatal period and infancy. The next step forward Any skepticism on whether IVR in Tamil would work with such a diverse population and accents have been eliminated during our testing. We hope that through this endeavour mothers will have timely access to information and complications and at the same time AEFI would be better reported and addressed. This technology is being developed and refined so that it can be made massively scalable for government programs, since this is an enterprise solution for high volume, low cost but high quality interactive services. Once the technology is perfected, and the complete results from the pilot are available, we hope to expand the system and integrate it with the governmental system for monitoring pregnancy and infancy.

AEFI field investigation simulation training in EMRO Piloting an innovative training methodology to improve AEFI investigation in Sudan 1

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Abdelrahman Rahma , Abdullah Salma , Abdou Hanan Langar Houda 3 Balakrishnan Madhava 4 Ram

Following the April 2014 WHO mission to evaluate the Sudan national vaccine pharmacovigilance system and the capacity of the national AEFI committee to perform AEFI causality assessment, the Ministry of Health and WHO country office, Sudan requested the WHO Safety and Vigilance (SAV) team to enhance national and sub national capacity to strengthen AEFI investigation. In November 2014, WHO conducted a unique AEFI field investigation simulation training for 36 surveillance officers from 18 provinces and also the National EPI, the NRA and the national AEFI committee. This innovative field investigation simulation approach developed by WHO primarily addresses challenges common in AEFI investigations such as content, accurateness, timeliness and completeness. It aims to provide a “Real life – Hands on” experience to participants in conducting AEFI investigation, identify strengths and weaknesses of the existing system at the local, district, province and national levels. Upon completion of the training, the participants felt better equipped to conduct AEFI field investigation resulting in improved causality assessment practices. The method also helps the national AEFI committee to identify lacunae existing in assessing causality and provide recommendations for improvement. Prior to the training in November 2014, the EPI program in Sudan selected “immunization error after measles vaccine” as the AEFI to be simulated. The program managers identified the Sahafa periurban 1

Expanded Program on Immunization Department, Ministry of Health, Sudan WHO Country Office, Sudan 3 Vaccines Regulation and Production (VRP), WHO/EMRO, Cairo 4 Safety and Vigilance (SAV), Department of Essential Medicines and Health Products, World Health Organization, Geneva 2

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area where the simulation exercise could be conducted. The Sahafa health and cold chain centre staff agreed to “act” the roles of the vaccinator, parents, child, doctor, cold chain staff and lab technician. They also arranged the training centre for class room sessions, the logistics, suitable program organizing support and vehicles for transportation. With the assistance of facilitators from the EPI program, WCO Sudan, WHO EMRO and WHO HQ, rehearsals were conducted with the “actors” over a standard script and suitable program organizing supports were arranged. The participant training started with classroom sessions on AEFI investigation and causality assessment followed by orientation of the field investigation methodology. The participants were then assigned to four groups with facilitators. Site visits were made and interviews on rotation conducted with vaccinator, parents, hospital and immunization centre staff. The participants prepared a report and dossier based on the documentation, observations and feedback obtained during the exercise. This was presented to the AEFI committee. The committee reviewed the dossier and discussed the causality assessment procedure with the wider audience and identified issues that need to be urgently addressed. The WHO team clarified the technical queries of the participants and the committee members. The feedback from the trainee investigators indicated that the creation of such an “artificial” AEFI crisis in a safe, simulated stress-free setting benefited peer-to-peer learning an interactive, friendly, group environment. It also prepared the would-be investigators to face future potential vaccine safety crisis confidently, fully armed with knowledge and the technical knowhow required for tackling such situations. The field simulation promoted team work; the groups quickly learnt that AEFI investigation is not a simple “one person – one time” activity; but a meticulous process where teamwork is critical particularly in obtaining information and expertise from different geographic locales with varied skills, experiences and background. The Sudan EPI program and the NRA identified the challenges of AEFI investigation in the local context that needs to addressed immediately for example; streamlining data collection and transmission procedures, addressing difficulties faced during specimen collection, storage, shipment, processing and funding of laboratory tests, etc. The training was used as an opportunity for the national AEFI committee to revisit AEFI causality assessment under the guidance of global, regional and national experts. The assessment of the simulated case gave field officers a “ringside view” of the national AEFI causality assessment procedures and its challenges. 6


AEFI in Brazil Adverse events following immunization (AEFI) reported after quadrivalent Human Papillomavirus Vaccination (HPV4) in the State of Rio Grande do Sul (RS), Brazil, 2014. Sandra M. Deotti1 and Renate Morhdieck1 In March 2014, Brazil introduced the HPV4 vaccination in its routine program to girls from 11 to 13 years of age, using the strategy to vaccinate at schools targeting higher coverage. Adverse events following immunization (AEFI) reporting is mandatory by a Ministry of Health (MoH) Ordinance and stimulated AEFI surveillance was initiated. Case definitions from the Manual of Surveillance of AEFI, National Immunization Programme, MoH were used to confirm the diagnosis. In the State of Rio Grande do Sul (RS), AEFI were reported and investigated by a technical team that interviewed the health workers involved in handling the cases, the adolescents and their families. Further examinations were requested and conducted by experts accompanied by the staff. Results: Non-serious reported AEFI AEFI Syncope Exanthema, rash, hives

Nº of cases 41

Cases/applied doses 1/5.235

Cases/100.000 doses* 19,1

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1/42.924

2,3

Other mild events

104

1/2.063

48,5

Total

164

1/1.309

76,4

Source: Coordination of Immunization/Secretary of Health/RS/BRA * Total doses: 209,000

Serious reported AEFI AEFI Anaphylaxis

Nº of cases 6

Cases/applied doses 1/35.770

Cases/100.000 doses 2,8

Convulsions

2

1/107.311

0,93

Bell palsy

1

1/214.622

0,47

Total

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1/23.847

4,2

Source: Coordination of Immunization/Secretary of Health/RS/BRA * Total doses: 209,000

Conclusions: The 6 cases of anaphylaxis occurred at one particular school and with the same batch. Fortunately the health professional team administered first aid immediately and all cases had good outcome. The batch was suspended as a precaution although this same lot was distributed to other states in Brazil with no serious adverse event (SAE) reported.

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Ministry of Health – Brazil Recommendations of the Advisory Committee on Immunization Practices (ACIP).

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The stimulated AEFI surveillance was able to detect non-serious AEFI at rates below than those reported in literature12. Moreover, anaphylaxis reporting rate was similar to a study described in Australia3. This significant incidence of serious AEFIs can be explained by the following factors: a very sensitive AEFI surveillance system in RS; the vaccination strategy in which a large number of doses were applied (219,000 doses) in a very short period of time favoring the clustering of adverse events, besides the small post-marketing usage of this vaccine and reporting of serious events have not been fully described. This work reinforces the importance of AEFI post-marketing surveillance and when vaccination happens in other locations than health units, adequate support for treatment is necessary for the greater security of the user population.

Focus on Africa Building vaccine safety and pharmacovigilance capacity in Africa - AEFI causality assessment workshop in Kinshasa Isabelle Sahinovic4 and Patrick Zuber4 In follow up of the two workshops held in Ivory Coast and Ghana in April and May 2014 for 15 African countries, a four day workshop on vaccine safety monitoring, investigation and causality assessment took place early December 2014 in the Democratic Republic of Congo.

Participants at the AEFI Causality Assessment workshop, Kinshasa, DRC December 2014. 1

Recommendations of the Advisory Committee on Immunization Practices (ACIP). Quadrivalent Human Papillomavirus Vaccine. MMWR, 56(RR02);1-24. 2 Goncalves AK, et al. Safety, tolerability and side effects of human papillomavirus vaccines: a systematic quantitative review. Braz J Infect Dis. 2014. http://dx.doi.org/10.1016/j.bjid.2014.02.005 3

Brotherton J.M.L. et al. Anaphylaxis following quadrivalent human papillomavirus vaccination. CMAJ 2008;179(6):525-33 4

.Safety and Vigilance (SAV), Department of Essential Medicines and Health Products, World Health Organization, Geneva

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The objective of the workshop was to train national managers on the concepts and tools for enhancing vaccine safety monitoring and evaluating serious adverse events following immunization (AEFI). This 4-day national workshop was organized jointly with WHO AFRO and DRC WCO. Participants included members from the national AEFI review committee including the pharmacovigilance centre located at Kinshasa University, senior managers from the Ministry of Health in disease control, immunization programs and the national regulatory authority (Direction de la pharmacie et des médicaments) together with partner agencies (UNICEF, MSH). There were four observers from other countries (Burundi, Cameroon, Côte d’Ivoire and Guinea) and two facilitators came from Senegal NRA and Burundi WCO. Members from the national team served as co-facilitators for the main modules ensuring good discussion of the topic. Particular emphasis was placed on discussions of the national system leading to a revision of the country work plan previously developed. There is expectation from all participants that this will be followed by concrete actions. The WCO will provide quarterly progress reports on follow-up activities. One main opportunity will be to promote active collaboration between the immunization program, the NRA and the PV centre. Promoting AEFI reporting throughout the health care system will require joint efforts, emulating the currently established network. Next steps  

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Maintain technical support to DRC for capacity-building in 2015 Involve DRC participants in capacity-building efforts for other French-speaking countries Provide quarterly updates on DRC progress in vaccine pharmacovigilance

This newsletter aims to provide information to persons working on vaccine safety on recent developments of the Global Vaccine Safety Initiative. Its content has been provided by vaccine safety experts worldwide and has been compiled by the WHO Secretariat. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by the World Health Organization to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall the World Health Organization be liable for damages arising from its use.

Essential Medicines & Health Products Safety & Vigilance Global Vaccine Safety

[email protected]

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