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SOUTH AFRICAN QUALIFICATIONS AUTHORITY

REGISTERED QUALIFICATION:

Higher Certificate in Vaccinology

SAQA QUAL ID	QUALIFICATION TITLE
102337	Higher Certificate in Vaccinology
ORIGINATOR
Sefako Makgatho Health Sciences University
PRIMARY OR DELEGATED QUALITY ASSURANCE FUNCTIONARY			NQF SUB-FRAMEWORK
CHE - Council on Higher Education			HEQSF - Higher Education Qualifications Sub-framework
QUALIFICATION TYPE	FIELD		SUBFIELD
Higher Certificate	Field 09 - Health Sciences and Social Services		Preventive Health
ABET BAND	MINIMUM CREDITS	PRE-2009 NQF LEVEL	NQF LEVEL	QUAL CLASS
Undefined	120	Not Applicable	NQF Level 05	Regular-Provider-ELOAC
REGISTRATION STATUS		SAQA DECISION NUMBER	REGISTRATION START DATE	REGISTRATION END DATE
Reregistered		EXCO 0821/24	2021-07-01	2027-06-30
LAST DATE FOR ENROLMENT		LAST DATE FOR ACHIEVEMENT
2028-06-30		2031-06-30

In all of the tables in this document, both the pre-2009 NQF Level and the NQF Level is shown. In the text (purpose statements, qualification rules, etc), any references to NQF Levels are to the pre-2009 levels unless specifically stated otherwise.

This qualification does not replace any other qualification and is not replaced by any other qualification.

PURPOSE AND RATIONALE OF THE QUALIFICATION

Purpose:
The Higher Certificate in Vaccinology (HCert (Vacc)) is designed to equip Healthcare Workers (HCWs) with the theoretical knowledge and practical expertise necessary for running an up-to-date clinic offering infant/childhood vaccination services. The HCert (Vacc) introduces students to key concepts in vaccinology, and at the end of the qualification students will be knowledgeable about vaccine-preventable diseases, vaccines, vaccination and immunisation, and will be able to apply this knowledge in the practice of vaccine delivery and administration within the framework of EPI-SA.

Rationale:
Discussions about developing a vaccinator accreditation qualification were initiated in 2014 by the National Advisory Group on Immunisation (NAGI), an advisory committee appointed by the Minister of Health. The South African Vaccination and Immunisation Centre (SAVIC) at the institution agreed to develop such a qualification. The Higher Certificate in Vaccinology (HCert: Vacc) qualification is an introductory qualification for in-service healthcare workers (HCWs) who work in Expanded Qualification on Immunisation of South Africa (EPI-SA) and in the private sector health facilities offering infant/childhood vaccination services. While the majority of these HCWs are Registered Nurses, a significant proportion of them are medical doctors (general practitioners and paediatricians), and pharmacists who have been trained in cold chain management and vaccination.

The rationale for introducing this qualification at the institution arises from several imperatives:

First, there is a high demand for this qualification from the National Department of Health (NDoH) and NAGI. This demand arises from the challenges experienced by EPI clinics in both the private and public sectors. The field of vaccinology is a rapidly developing and is a highly dynamic field, with new technologies and vaccines being introduced on a regular basis. Currently in the private sector, a HCW who qualified many years ago and has no recent education in vaccination, is able to open up a private vaccination clinic. And in both the private and public sectors, newly qualified HCWs are often ill-equipped to work within an EPI clinic. This results not only in them having to be trained on-the-job by more experienced HCWs who are already over-stretched, but results in unfortunate serious mistakes and unnecessary adverse events following immunisation.

Second, public trust in vaccination is waning globally, and HCWs are often ill-equipped to deal with the questions asked of them by caregivers/parents who have been exposed to misinformation on the Internet or other mass media. In fact many HCWs themselves are so overwhelmed by the ubiquitous anti-vaccination misinformation that they themselves have become anti-vaccination. There is thus a great need for HCWs to understand the science behind vaccines, in order to increase the vaccination uptake.

Third, universities can and do play a very important role in providing in-service education and training of HCWs in vaccinology. SAVIC was established in 2003 (at the then Medical University of Southern Africa) to strengthen collaborations between academics, the NDoH, the vaccine industry and other stakeholders, with the overall aim of supporting immunisation services. Although there are a number of players in the field of vaccines and immunisation, SAVIC has the unique aim of strengthening immunisation qualifications by bridging the gap through cascading of up-to-date information to in-service HCWs via various outreach initiatives. Thus, SAVIC creates a platform whereby experts from universities, the NDoH and provincial departments of health, the vaccine industry, non-governmental organisations and Public/Private Partnerships interact in a joint effort to improve public health qualifications concerning vaccine-preventable diseases.

This qualification will provide great benefits to the HCWs, society and the economy. HCWs will develop a greater understanding of the fundamentals of immunisation, which will not only improve their vaccination practices and prevent serious adverse events following immunisation, but will also help them to promote vaccinations with confidence. This will result in increased public demand for the protection of children through immunisation, thus increasing vaccination uptake, and decreasing the incidence of vaccine-preventable diseases. Vaccination has been shown to be the most cost-effective public health intervention against infectious diseases, thus the benefit to the economy will grow in line with increased vaccination uptake.

Finally, this qualification is for in-service HCWs who are employed in health facilities offering vaccination services throughout South Africa.

LEARNING ASSUMED TO BE IN PLACE AND RECOGNITION OF PRIOR LEARNING

Recognition of Prior Learning (RPL):
This qualification adheres to the institution's RPL policy, which is aligned with the SAQA's RPL Policy. It is important to note that the entry requirements for the HCert (Vacc) have been set at the lowest qualification that permits South African HCWs to administer vaccinations. This is because the qualification has been specifically designed to improve the vaccination practices of in-service HCWs who administer vaccinations, while all other vaccinology qualifications globally are at post-graduate level. Vaccination experience will furthermore be recognised as prior learning amongst HCWs admitted into the qualification. Modules 6 to 11 all have practical assignments which are based on vaccination practices. Students who are already competent in vaccination practices and can produce evidence of this competence, will be able to submit this evidence and thus be exempt from completing these assignments. Their supervisor/manager/employer will be required to complete and sign a certificate of practice for each specific task, and these certificates will form part of the Portfolio of Vaccinology Theory and Practice. Thus full credits for these practical assignments will be allocated to these students. Students would not have accumulated credits for the online parts of the modules, since these modules are unique to the HCert (Vaccinology), and have been designed to keep vaccinators up-to-date with the very latest developments within the field of vaccinology.

Entry Requirements:
The requirements for the admission to the Higher Certificate in Vaccinology are:

Registered General Nurse and Midwife with the SA Nursing Council.
Or

A 3 year qualification in a relevant health science (i.e. in which training in vaccinating is included).
Or

Medical doctors enrolling for the HCert must be registered with the Health Professions Council of SA, while pharmacists must be registered with the SA Pharmacy Council.

RECOGNISE PREVIOUS LEARNING?

QUALIFICATION RULES

This qualification consists of compulsory modules at Level 5 totalling 120 Credits.

Compulsory Modules at Level 5, 120 Credits:

Introduction to Human Infectious Disease Immunology, 4 Credits.

Introduction to Vaccinology, 4 Credits.

Introduction to Vaccine Manufacturing and Distribution, 4 Credits.

Introduction to the Expanded Qualification on Immunisation of South Africa (EPI-SA), 4 Credits.

Introduction to the Epidemiology of Vaccine-Preventable Diseases and the Corresponding Vaccines used within the EPI, 32 Credits.

EPI Vaccination Schedules and Strategies in South Africa, 12 Credits.

Introduction to Cold Chain Management, 12 Credits.

Introduction to the Safe Administration of Vaccines, 12 Credits.

Introduction to Adverse Events Following Immunization, 12 Credits.

Introduction to Advocacy, Communication and Social Mobilisation to Increase Vaccination Uptake, 12 Credits.

Monitoring and Evaluation of EPI-SA, 12 Credits.

EXIT LEVEL OUTCOMES

1. Understand human host defense mechanisms against infectious diseases.
2. Understand and describe vaccinology.
3. Understand and describe how the different vaccines are manufactured and distributed.
4. Understand and describe the origins, success and current targets of EPI-SA.
5. Understand and describe the epidemiology of the VPDs prevented by EPI-SA, and explain all aspects of the vaccines used to prevent them.
6. Recall the vaccination schedules (private and public sectors); explain the different vaccination strategies within EPI-SA; and apply the above schedules and strategies in practice.
7. List and describe all the key issues of cold chain management and apply cold chain management in vaccinology practice.
8. List and describe all the key issues around the safe administration of vaccines, and practice safe vaccination procedures.
9. Explain all the key issues regarding AEFIs and apply AEFI-related procedures in practice.
10. Describe all the key issues around advocacy, communication and social mobilisation to increase vaccination uptake; and advocate/communicate effectively about vaccination in order to mobilise the community towards increased vaccination coverage.
11. Describe how immunisation qualifications are monitored and evaluated; and monitor and evaluate vaccination services, vaccination coverage and data management.

ASSOCIATED ASSESSMENT CRITERIA

Associated Assessment Criteria for Exit Level Outcome 1:

Explain why humans need to defend themselves against infectious diseases:
> Explaining the contribution of infectious diseases to human morbidity (sickness) and mortality (death), with an emphasis on developing countries.
And
> Outlining the characteristics of bacteria and viruses that allow these organisms to cause disease in humans.

Explain how the human immune system works by:
> Explaining the differences between non-specific and specific (adaptive) immunity.
> Defining the two arms of adaptive immunity.
> Outlining how the two arms of adaptive immunity work.

Associated Assessment Criteria for Exit Level Outcome 2:

Outline how vaccinology mimics human host defense mechanisms to prevent infectious diseases by:
> Explaining what a vaccine contains.
> Outlining how vaccines work.
And
> Describing what makes an ideal vaccine.

Describe the different types of vaccines by:
> Differentiating between live and killed/inactivated vaccines.
> Differentiating between whole cell and subunit/fractional vaccines.
> Describing the different nomenclatures of vaccines.

Associated Assessment Criteria for Exit Level Outcome 3:

Explain how vaccines are manufactured by:
> Differentiating between vaccines and pharmaceuticals in terms of manufacturing.
> Listing the basic steps in vaccine manufacturing.
> Listing the tests conducted during production.
> Listing the different authorities responsible for releasing vaccine lots.

Explain how vaccines are distributed by:
> Explaining at what stage vaccines can be distributed.
> Explaining why and under what conditions vaccines are distributed.
> Listing the packing requirements for the distribution of vaccines.
> Explaining the requirements for the conditions under which vaccines should be transported.
> Explaining the importance of following standard operating procedures in the distribution of vaccines.

Associated Assessment Criteria for Exit Level Outcome 4:

Explain the origins of EPI and EPI-SA by:
> Explaining why and when the World Health Organization launched the EPI.
> Listing the vaccines.

Explain the successes of EPI-SA by:
> Describing how EPI-SA is addressing global health priorities including the Sustainable Development Goals, the Global Polio Eradication Initiative, the Decade of Vaccines and the Global Vaccine Action Plan.
> Listing the diseases that have been eradicated or eliminated, including the years when these were eradicated/eliminated.
> Listing the vaccines that have been successfully integrated into the EPI-SA from 1995 to 2014.

Discuss the current targets of the EPI-SA:
> Listing the current targets of the EPI-SA.
> Explaining the strategies being followed to meet these targets.

Associated Assessment Criteria for Exit Level Outcome 5:

Discuss the epidemiology of infectious diseases prevented by EPI-SA by:
> Naming the causative organisms of all VPDs targeted by EPI-SA.
> Outlining how the causative organisms are transmitted.
> Describing the population at risk for each VPD.
> List the symptoms of each VPD.
> List the outcomes of each VPD.
> Explain where morbidity and mortality from VPDs occur (global, sub-Saharan Africa and South Africa).

List and describe the different vaccines used within EPI-SA by:
> Describing the form and presentation of each vaccine.
> Explaining how each vaccine works.
> Describing the safety profile of each vaccine.
> Describing the effectiveness of each vaccine.
> Listing the schedule/s for each vaccine.
> Naming the target age group for each vaccine.
> Describing how each vaccine is administered.

Associated Assessment Criteria for Exit Level Outcome 6:

Recall the vaccination schedules and different vaccination strategies within EPI-SA by:
> Listing the EPI-SA vaccine schedule including all the vaccines given at the specific ages.
> Listing the vaccine schedules used in the private sector of South Africa, including all the vaccines given at the specific ages.

Explain the different vaccination strategies within EPI-SA by:
> Explaining the basis for using the WHO's accelerated routine vaccination strategy in South Africa.
. Listing the vaccines that must be given to pregnant women, and when they should be given.
> Listing the vaccines that must not be given to pregnant women.
> Explaining the strategy for vaccinating HIV-positive babies.
> Explaining the strategy for vaccinating pre-term infants.
> Explaining the strategy for vaccinating infants born to mothers on TB treatment.
> Naming the vaccines that must be given to trauma victims.
> Listing the vaccines that healthcare workers should receive.
> Describing the catch-up vaccination strategy for babies who have missed vaccines.
> Explaining the Reach Every Child (in every Community) Strategy.
And
> Explaining the strategy of mass immunisation campaigns.

Apply the above schedules and strategies in practice by:
> Selecting the correct vaccines for 10 hypothetical babies relevant for their age, HIV-status, whether or not their mothers are on TB treatment, and taking into account if catch-up vaccination is needed.
> Selecting the correct vaccines for 10 hypothetical pregnant women relevant for their immunisation history and stage of pregnancy.
> As a healthcare worker, having proof of vaccination with all relevant vaccines.

Associated Assessment Criteria for Exit Level Outcome 7:

List and describe all the key issues of cold chain management by:
> Describing the requirements for the ideal refrigerator for storing vaccines.
> Explaining how to pack a vaccine refrigerator correctly.
> Describing the process of preparing and packing cold boxes for transporting vaccines.
> Describing how to do the shake test.
> Listing the steps for monitoring temperatures.
> Listing the procedures to follow when cleaning a vaccine refrigerator.
> Explaining how to use refrigerator tags.
> Describing how to read a vaccine vial monitor, and what steps to take based on the readings.
> Recalling the multi-dose open-vial policy of EPI-SA.
And
> Explaining the importance of following written standard operating procedures in cold chain management.

Apply cold chain management in practice by:
> Demonstrating how to pack a vaccine refrigerator correctly.
> Demonstrating the process of preparing and packing cold boxes for transport of vaccines.
> Demonstrating the shake test.
> Demonstrating how to use a refrigerator tag.
> Demonstrating how to clean a vaccine refrigerator.
> Reading at least five vaccine vial monitors, and stating the correct steps based on the readings.
> Checking all conditions to demonstrate adherence to the multi-dose open-vial policy of EPI-SA for all relevant vaccines.

Associated Assessment Criteria for Exit Level Outcome 8:

List and describe all the key issues around the safe administration of vaccines by:
> Describing the correct injection equipment.
> Explaining how to avoid needle-stick injuries and infections.
> Describing how to position children correctly for injections.
> Outlining the steps for safe disposal of injection equipment.

Practice safe vaccination procedures by:
> Using the correct injection equipment for at least 10 simulated vaccinations.
> Avoiding needle-stick injuries while performing these simulated vaccinations.
> Position dummy babies correctly when administering these simulated vaccinations.
> Safely disposing of injection equipment after these simulated vaccinations.

Associated Assessment Criteria for Exit Level Outcome 9:

Explain all the key issues regarding AEFIs by:
> Explaining how to prevent AEFIs.
> Discussing the management of AEFIs.
> Describing the reporting of AEFIs.
> Explaining how AEFIs are investigated.
> Outline AEFI communication.

Apply AEFI-related procedures in practice by:
> Demonstrating management of 10 hypothetical AEFIs.
> Identifying the correct AEFI forms that must be used and completing these forms.
> Providing the event description for each hypothetical AEFI.
> By simulating the reporting of these AEFIs.

Associated Assessment Criteria for Exit Level Outcome 10:

Describe all the key issues around advocacy, communication and social mobilisation to increase vaccination uptake by):
> Explaining the meaning of advocacy and who advocacy is directed at.
> Discussing the meaning of communication, who is included in communication, and when communication is successful.
> Listing the essential information that must be given to caregivers when communicating about vaccination.
> Explaining the meaning of social mobilisation.
> Explaining why advocacy, communication and social mobilisation are needed.
> Discussing how to build trust.
> Listing the different types of explanations and when they should be used.
> Discussing how to counter anti-vaccination myths.

Advocate/communicate effectively about vaccination in order to mobilise the community towards increased vaccination coverage by:
> Communicating essential vaccination information to 10 hypothetical caregivers who have no questions about vaccinating their babies.
> Giving relevant explanations to 10 hypothetical caregivers who have asked questions about vaccination.

Associated Assessment Criteria for Exit Level Outcome 11:

Describe how immunisation qualifications are monitored and evaluated by:
> Explaining the importance of immunisation data.
> Listing the main EPI indicators used for monitoring EPI performance.
> Describing the use of basic data collection tools.
> Explaining the processes for data collection.

Monitor and evaluate vaccination services, vaccination coverage and data management inclusive of by:
> Using the relevant data collection tools while collecting data from a hypothetical clinic.
> Processing the data correctly.
> Reporting on the main EPI indicators.

Integrated Assessment:
Formative assessment is used throughout the qualification as a teaching tool, and students are allowed to repeat all formative assessments as many times as they need to in order to master each module. Once they have successfully mastered all modules, they will be assessed as Exceptionally Competent, Highly Competent, Competent or Not Yet Competent based on a summative assessment by qualification faculty, of the final Portfolio of Vaccinology Theory and Practice submitted at the end of the qualification, and moderated by external examiners. Students are provided with an Assessment Criteria Grid at the beginning of the qualification to enable self-assessment while compiling the portfolio, and qualification faculty use the same assessment criteria grid for the evaluation of the portfolio.

INTERNATIONAL COMPARABILITY

Internationally, there are no qualifications in Vaccinology being offered at the undergraduate level. There is however postgraduate qualifications offered at a much higher level, such as the following:

The University of Lausanne offers a two-year International Master in Vaccinology (IMVACC), developed by the Swiss Vaccine Research Institute and the Health Sciences e-Training Foundation in collaboration with the Lausanne University Hospital.

The University Paris-Est Cr�teil offers a two-year Master of Science Biology and Health: Vaccinology.

The University of Siena offers a two-year Master in Vaccinology.

In addition, there are many short Vaccinology courses for certificates of attendance offered by organisations such as the Network for Education and Support in Immunisation, based at the University of Antwerp in Belgium, who in collaboration with the World Health OrganiSation and other partners, including SAVIC, presents short Vaccinology courses in various countries throughout Africa; the International Vaccine Institute in the Republic of Korea; the East Africa Centre for Vaccines and Immunisation, based at Egerton University in Kenya, and Makerere University College of Health Sciences in Uganda, with whom SAVIC has recently signed a Memorandum of Understanding which includes offering Vaccinology training in southern and eastern Africa. These short courses cover the same topics as the HCert (Vaccinology), but always at a higher level since they generally target National Immunisation Technical Advisory Group members, policy makers, and EPI managers. As a number of our HCert (Vaccinology) external moderators are from international Higher Education Institutions (University of Antwerp; University of Adelaide; London School of Hygiene and Tropical Medicine) and participate as faculty in some of these short courses and international masters qualifications, the HCert (Vaccinology) and future vaccinology qualifications that we are in the process of developing, will benefit from international bench marking.

ARTICULATION OPTIONS

Horizontal Articulation:

Horizontal articulation will not be possible, since the students will be in-service HCWs who work as vaccinators, thus they will already have a basic qualification at a higher level than Level 6. This is because South African HCWs are not permitted to vaccinate unless they are either a Registered General Nurse and Midwife with the SA Nursing Council, or have a 3 year qualification in a relevant health science (i.e. in which training in vaccinating is included) from a tertiary institution registered with the HPCSA.

Vertical Articulation:

This is the very first undergraduate vaccinology qualification to be developed, not only in South Africa, but globally. There are thus currently no other vaccinology undergraduate qualifications to allow for articulation.

MODERATION OPTIONS

N/A

CRITERIA FOR THE REGISTRATION OF ASSESSORS

N/A

NOTES

N/A

LEARNING PROGRAMMES RECORDED AGAINST THIS QUALIFICATION:

NONE

PROVIDERS CURRENTLY ACCREDITED TO OFFER THIS QUALIFICATION:

This information shows the current accreditations (i.e. those not past their accreditation end dates), and is the most complete record available to SAQA as of today. Some Primary or Delegated Quality Assurance Functionaries have a lag in their recording systems for provider accreditation, in turn leading to a lag in notifying SAQA of all the providers that they have accredited to offer qualifications and unit standards, as well as any extensions to accreditation end dates. The relevant Primary or Delegated Quality Assurance Functionary should be notified if a record appears to be missing from here.

1.	Sefako Makgatho Health Sciences University