EXPANDED PROGRAM ON IMMUNISATION IN SOUTH AFRICA (EPI-SA) - PowerPoint Presentation

1. EXPANDED PROGRAM ON IMMUNISATION IN SOUTH AFRICA (EPI-SA) SAHPRA WEBINAR ON ADVERSE EVENTS REPORTINGE MASETI: DEPUTY DIRECTOR – EXPANDED PROGRAM ON IMMUNISATIONNATIONAL DEPARTMENT OF HEALTH6 NOVEMBER 2023

2. 2SIDE EFFECTS ASSOCIATED WITH VACCINES EXPERIENCED AT NDOH, EPI

3. DEFINITION OF ADVERSE EVENTS FOLLOWING IMMNUISATION 3…any untoward medical occurrence which follows immunisation and which does not necessarily have a causal relationship with the usage of the vaccine. The adverse event may be any unfavorable or unintended sign, abnormal laboratory finding, symptom or disease.General public has low tolerance to adverse events as vaccines are usually given to healthy persons.Expectation to safety standard is higher with vaccines compared to medicines for sick people.National regulatory authorities (NRAs) ensure with rigor the quality, safety, & effectiveness of vaccines and pharmaceutical products.Before being introduced, vaccines are assessed in clinical trials.NRAs monitor and investigate AEFIs to ensure safety for population.Once introduced, vaccines are thoroughly and continuously reviewed.

4. WHAT IS AN ADVERSE EVENT OF SPECIAL INTEREST (AESI)?4Adverse events of special interest are pre-specified medically significant events Have the POTENTIAL to be causally associated with a vaccine productExample: AnaphylaxisActive vaccine surveillance is very important for the monitoring of AESICompare incidence of AESI for COVID-19 vaccinated and unvaccinated individualsDetermine if there is a link between the AESI and the COVID-19 vaccine productDetermine if there is need for further specific studies to confirm such an associationMonitor all vaccines!

5. SIDE EFFECTS/EVENTS ASSOCIATED WITH VACCINES5All vaccines used in national immunisation programs are safe and effective if used correctly under recommended conditions.No vaccine is completely risk-free and adverse events will occasionally result after an administration of a vaccine.Adverse events can range from minor side-effects to much more severe reactions and can be a cause of public concerns about vaccine safety. What caused the reaction?Vaccine Safety:In case of an event, check if:Was it related to the vaccine unrelated? Can you distinguish between minor and severe reactions?

6. Very mild side effectsVery common (More than 1 in 10)Common (1 to 10 in 100)More troublesome side effectsUncommon1-10 in 1000Very serious medically significant adverse effects; Extremely rare (1 in 100 00 or 1 in million)Serious medically significant adverse effectsRare (1-10 in 10 000)Very rare (Less than 1 in 10 000)EXPECTEDDo not pose a potential riskUsually occur within a few hours of vaccinationResolve after short period of timeSelf-limiting, hardly requiring treatmentLocal and systemic reactionsPart of the immune responseOther vaccine components can trigger reactions Inform and assure vaccine recipients about eventsNOT EXPECTEDSerious eventsResult in deathRequire inpatient hospitalisationLife threateningResult in persistent or significant disability/incapacityCongenital anomaly/birth defectMedically important eventsMINOR EVENTSSEVERE EVENTS

7. SIDE EFFECTS/EVENTS ASSOCIATED WITH VACCINES7SEVERE REACTIONSMINOR REACTIONSVaccineLocal reactionsSystemic reactions(pain, swelling, redness)Fever > 38°CIrritability, malaise and systemic symptomsBCG90% – 95%––Hepatitis BAdults up to 15%, Children up to 5%1 – 6%–Hib5 – 15%2% – 10%Measles/MR/MMR~ 10%5% – 15%5% (Rash)OPVNoneLess than 1%Less than 1%Pertussis (DTwP) up to 50%up to 50%up to 55%Pnemucoccal conjugate5~ 20%~ 20%~ 20%Tetanus/DT/aTd~ 10%4~ 10%~ 25TreatmentCold cloth at injection siteParacetamolGive extra oral fluidsWear cool clothingTepid sponge or bathParacetamolGive extra oral fluidsParacetamol

8. SIDE EFFECTS/EVENTS ASSOCIATED WITH VACCINES8Death in vaccinated people can occurPerson already incubating another disease at the time of vaccination OR Person got sick shortly after being vaccinated, before mounting an adequate immune response Non vaccine related deaths can happen coincidentally after being vaccinatedWould have happened regardless of the person being vaccinated or not Suffering from a chronic comorbid condition  risk factor for deathMain goal of the vaccination programme Prevent severe illness Prevent premature deaths of the elderly and people with chronic illnesses Elderly people Already at a much higher risk of dying than the general populationVaccines prevent dying from a specific disease if vaccinated in timeVaccines cannot prevent death from chronic diseases

9. 9WHAT DOES EPI DO TO ENSURE PATIENT SAFETY WITH REGARDS TO SIDE EFFECTS EXPERIENCED POST VACCINATION?

10. ImmunisationNotification and Reporting Management of AEFIInvestigation Causality AssessmentAnalysis AEFI Detection (reported or identified)Feedback and PreventionNational Immunisation Safety Expert Committee (NISEC)Healthcare workerVaccine recipient / caregiver / vaccinatorNational Department of HealthImmunisation ProgrammeHealthcare workerMulti-disciplinary teamProvincial and National TeamSouth African Health Products Regulatory Authority (SAHPRA)World Health Organization (WHO)Vaccine Manufacturing IndustryMinisterial Advisory Committees on Vaccines and ImmunisationNational Department of Health (NDoH)12347856Vaccine safety surveillance cycle in SA

11. IMPORTANCE OF DETECTING AND INVESTIGATING ANY ADVERSE EVENT FOLLOWING IMMUNISATION11

12. ROLE OF THE DEPARTMENT TO ENSURE VACCINE SAFETY12PV responsibilities:Causality assessment National AEFI & AESI line list Update cases on Vigilance hub Monitoring cases on Vigilance hubProviding feedback to the committee, provinces

13. ROLE OF THE DEPARTMENT TO ENSURE VACCINE SAFETY13Provincial AEFI CommitteesStrengthen AEFI reporting in the provincesEnsure maintenance of national policy and standardsEnsure prompt and thorough investigation of severe and serious AEFICarry out periodic review of AEFI for trends of non-serious AEFIs reportedRespond to media and community concerns  allay fears regarding vaccine safetyEnsure high AEFI surveillance standards ensure no serious AEFI are missedNational AEFI CommitteesConduct the causality assessment of AEFI cases (serious events)Co-ordinate communication between AEFI/AESI investigators, immunisation staff, clinicians, patients, parents, and NISEC members during the investigation process. Advise the Committee on relevant policy, administrative and regulatory matters. Coordinate and facilitate any research or investigations that are required for the Committee to perform its functions. Monitor the implementation of recommendations.

14. A1 Vaccine product-related reactionIndividual’s response to inherent properties of vaccine, even when vaccine has been prepared, handled and administered correctlyCAUSALITY ASSESSMENT CLASSIFICATIONCONSISTENT WITH CAUSAL ASSOCIATION TO IMMUNISATIONA2Vaccine quality defect-related reactionCaused or precipitated by vaccine, due to one /more quality defects of the product, including its administration device, provided by manufacturer A3Immunisation error-related reactionCaused by inappropriate vaccine handling, prescribing or administration A4Immunisation stress-related reaction Arising from anxiety about the immunisation and fear of injection e.g. fainting

15. CCoincidental eventAn event that happens after vaccination but is not caused by the vaccine or vaccination processEvent caused by something other than the vaccine product, immunisation error or immunisation anxietyCAUSALITY ASSESSMENT CLASSIFICATIONInconsistent with causal association to the immunisationImplications for the immunisation programmePotential comorbidities  especially in elderly e.g. hypertension, diabetes, heart disease Coincidental events can occur in healthy individuals without comorbiditiesNewly acquired or diagnosed illnessSpontaneous occurrence of an event without known risk factorsOther exposures to drugs or toxins prior to eventSurgical or other trauma leading to a complicationsEstimate population-based background rates Pre-specified adverse events of special interest Mortality per age group / disease

16. http://gvsi-aefi-tools.org/Manual: Causality assessment methodology (2019)Access causality assessment softwarehttp://gvsi-aefi-tools.org/ Software developed to support use of the methodology, translated to six UN languagesAEFI Causality Assessment WorksheetCAUSALITY ASSESSMENT OF SEVERE AND SERIOUS AEFI CASESWHO METHODOLOGY: SOFTWARE TO GUIDE AEFI CAUSALITY ASSESSMENT

17. PREREQUISITES FOR AEFI CAUSALITY ASSESSMENT17123Case investigation completedCRF and CIF completed, with case investigation completedSpecific diagnosisThere must be a specific “diagnosis” (clinical sign, abnormal laboratory finding, symptom and/or disease) which is being investigated for and association with immunisationDetails and evidenceAll details of the case should be available at the time of assessment, including supporting documentation (clinical notes, laboratory results, autopsy report, etc.)Information is absolutely ESSENTIAL for ALL vaccines

18. FACTORS TO CONSIDER IN DETERMINING CAUSALITY18Eligibility of the case?Strong evidence for other causes?Known causal association with the vaccine?Did the event happen within the time window?Strong evidence against a causal association?Are there any other qualifying factors?

19. IMPORTANCE OF COMMUNICATION TO AVOID RUMOURS, MISINFORMATION & MISCONCEPTIONS19

20. NEVER OVERSIMPLIFY OR WITHHOLD INFORMATION20 DO NOTDo not leave the vaccinees or their families uninformed. It is unethical to conduct an invasive procedure without informed consent.Do not assume parents or the public will not understand information about vaccine safety. Inform vaccinees or their families on details about the vaccine:Vaccine name.What the vaccine protects against.Expected/potential adverse events.What to do if vaccinee experiences adverse events.As Healthcare provider communicate information: in understandable terms, ideally in written form ahead of the time of vaccination. DO

21. ATTRIBUTES OF A GOOD VACCINE21Effectively prevents or reduces severity of infectious diseaseProvides durable, long-term protection.Achieves immunity with minimal number of doses.Provides maximum number of antigens that confer broadest protection against infection.Causes no or mild adverse reactions.Is stable at extremes of storage conditions over a prolonged period of time.available for general use through mass production

22. THANK YOUwww.doh.gov.zaLove them, Immunise them, Feed them, Protect them,