H1N1 PANDEMIC: LESSONS LEARNT VIEWS FROM A COUNTRY RECEIVING DONATED PRODUCTS

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1 H1N1 PANDEMIC: LESSONS LEARNT VIEWS FROM A COUNTRY RECEIVING DONATED PRODUCTS Delese Mimi Darko Head of Pharmacovigilance and Clinical Trials Food and Drugs Board, Ghana

2 OUTLINE Ghana s Healthcare system National expanded programme on immunization (EPI) Current Status of H1N1 in Ghana The special case of H1N1 vaccine Experience in Ghana Reports Received Questions to be answered Way forward 2

3 Healthcare System in Ghana Ghana has both public and private sector for healthcare delivery 60 % of the population is covered by the public sector; 40% private (profit/not for profit) 80% of healthcare financing is through health insurance (private and public) Most vaccines are procured through the public sector and are stored in central cold storage facility as part of a 3 tier system Vaccines procured usually through UN Agencies (UNICEF; GAVI) 3

4 Expanded Programme on Immunization This is a National Programme with no opt outs It seeks to achieve maximum coverage for childhood immunization and is part of the Ministry of Health and Ghana Health Service National Immunization Schedule exists and strictly adhered to and immunization is free for all children High coverage is achieved across the country with special NIDs as back up. 4

5 CURRENT H1N1 SITUATION In Ghana, The Noguchi Memorial Institute for Medical Research is the WHO designated lab for lab diagnosis of Pandemic Influenza A H1N1. From May 2009 to date, 8066 people have been screened and 1036 cases have been confirmed. 1 death confirmed of 11 month old baby. Deployment of donated vaccines has been stopped across the country. Approximately 4000 doses remaining at central cold storage mopping up of remaining vaccines ongoing in all regions.

6 H1N1 EXPERIENCE IN GHANA First cases of H1N1 infection in Ghana reported on 5 th August, 2009 (female in her 20s) Outbreaks occurred in several schools National H1N1 Committee set up to assess situation and offer advice to government. Mass vaccination of targeted groups was considered Need for vaccine became urgent especially when it was made a pre condition to travel to South Africa for the Football World Cup 6

7 H1N1 EXPERIENCE IN GHANA In September 2009, WHO wrote to Minister of Health about availability of pandemic influenza vaccines Supply would be based on defined criteria. As part of the national response a technical committee was formed and charged to coordinate the development of a comprehensive deployment plan to identify specific actions that Ghana would take to address the threat of a pandemic.

8 H1N1 EXPERIENCE IN GHANA Purpose of Deployment Plan: To define procedure for timely and effective delivery of vaccines To distribute the vaccine to all storage points within 7 days of receipt in the country {national regional district sub district health facility} At that point coverage to address pandemic was the key issue not vaccine safety

9 H1N1 EXPERIENCE IN GHANA 2.3 million doses of H1N1 vaccine received (delivery expected as 2 batches but due to delay in supply came as 1 batch) Quantity based on approx 10% of population Target age years Target regions All 10 regions in the country Vaccination coverage schedule: 5 7 days per region

10 H1N1 EXPERIENCE IN GHANA Target groups Frontline health workers in government, quasigovernment and private health facilities Pregnant women National security personnel Other high risk (chronic medical disease conditions)

11 Other Interventions Deployment Operations cold chain monitoring Communication and Information Fact sheets, bulletins, other telecom channels Public Information Press briefing Inform target groups (administrative set ups, local FM radio, anti natal clinics) Regulatory Registration?? Pharmacovigilance/AEFI Monitoring?? (late)

12 Monitoring of AEFIs with Vaccine National and Regional level Training of EPI Managers (June 7, 2010) monitors and vaccinators taken through training on various aspects of the process including AEI monitoring and reporting. No adverse events of special interest (AESIs) were mentioned. Vaccine imported late May, vaccination started 4 th June

13 REPORT ON PANDEMIC INFLUENZA VACCINATION 7th 18 th JUNE 2010 CENTRAL REGION

14 Pregnant women were not left out

15 The Military came in their numbers

16 Summary of Reports Received Expected increased reporting compared to routine immunizations in children (Awareness) Over 900 reports were received in about 1 month (compare with average of 30 reports for all vaccines per annum) Media interruptions, rumours, scares and panic Campaigns launched against vaccinations by members of the public Minister for Health addresses Parliament on the issue and gives press statement. 16

17 SEX DTRIBUTION NUMBER MALES FEMALES

18 AGE DISTRIBUTION 300 NUMBER NUMBER Above 60 Unknown

19 CLASSIFICATION OF REACTIONS NUMBER OF PATIENTS CNS GENERAL BODY MALAISE FEVER, CHILLS, ETC AUTONOMIC NERVOUR SYSTEM GIT CARDIOVASCULAR RESPIRATORY SKIN REACTION LYMPH HEARING & VESTIBULAR VISION INJECTION SITE REPRODUCTIVE RECTICULAR ENDOTHELIAL SYSTEM MOTHER TO CHILD (BREASTFEEDING) BLOOD DISORDERS

20 GENERAL REACTION TERM DESCRIPTION OF REACTION NUMBER OF PATIENTS REPRODUCTIVE DISORDERS (8) Erectile dysfunction Feeling of heat in scrotum Swollen vulva Lack of libido Uterine contractions Threatened abortion (24 weeks) Premature delivery (baby died) Abortion RECTICULAR ENDOTHELIAL SYSTEM DISORDERS (16) MOTHER TO INFANT (BREASTFEEDING) (1) RED BLOOD CELLS DISORDERS (3) PSYCHIATRIC DISORDERS (10) METABOLIC AND NUTRITIONAL DISORDERS (20) Anaphylaxis Toxic shock Swollen face Mother child reaction 1 Anaemia Behaviour changes 10 Loss of appetite Hunger Thirst DEATH (3) 3

21 A staff at Bongo District in Upper East Region had rashes.

22 QUESTIONS

23 Did we do due diligence as regulators prior to arrival of the vaccines with respect to registration?? Are we expected to do so in the threat of a pandemic?? Was there a threat? Did we need to wait until there was?? This is a relatively new vaccine safety data still being actively gathered. Donated product who is the marketing authorisation holder. Who is responsible for monitoring its safety Manufacturer May not be represented in country Not applied for marketing authorisation

24 Donors Do they still have responsibility for the product? Are they still the marketing authorisation holder? Can they be required to undertake active studies in conjunction with the deployment of the donated products What can realistically be expected of donors especially during pandemics? Regulator Limited resources However legal mandated to ensure quality, safety and efficacy of regulated products Ultimate responsibility for public health and safety Usually not involved public health decision making

25 National Regulatory Functions Depend on Vaccine Source Regulatory functions Regulatory system Marketing Authorization & Activities licensing Postmarketing: AEFI Lot release Laboratory access Regulatory inspections Supervision of clinical trials Source of vaccines UN agency Procure Produce Functions Undertaken by WHO on Behalf of UN agencies or producing countries Functions undertaken By the producing country 25

26 Attempt at a WAY FORWARD/CONCLUSION Pandemics and threats come with challenges Donated vaccines come with their own challenges We cannot point fingers, we cannot fold our arms Pandemic reaction and response guidelines and plans should be developed. Protocols for active monitoring of all donated products should be developed with multi stakeholder involvement. The EPI programme should re sensitized to realize that safety is as important as coverage. The manufacturer needs the safety information and should therefore not be absolved of responsibility of his product even if donated. 26

27 Attempt at a WAY FORWARD/CONCLUSION Donor agency should be responsible for providing all the information needed by regulator especially in a pandemic situation. (safety data, AESIs, Art 58 decision for new vaccines etc) There will be other pandemics and we have to be prepared.

28 Nzulezu, Western Region

29 THANK YOU FOR YOUR ATTENTION