Assessment 5
Question 3
Reporting lines for AEFIs:
Identify one person or organization who should receive information from you, if you have been alerted to an AEFI, or a cluster of causally related AEFIs, assuming that you are:
| A. | A pharmacovigilance officer in the NRA |
| B. | A person working in a vaccination centre |
| C. | A Regional Health Officer |
Correct answers:
A. The vaccine manufacturer,
B. Immunization programme manager,
C. The National Regulatory Authority.
The National Immunization Programme is a national organisation within Ministry of Health responsible for protecting children and adults from vaccine-preventable diseases through the correct storage, handling, preparation and administration of safe, effective and high quality vaccines.
The Global Advisory Committee on Vaccine Safety (GACVS) is the multidisciplinary body responsible for advising WHO on global vaccine safety issues and the prompt, efficient and scientifically rigorous response to issues of vaccine safety with potential global importance.
The National Regulatory Authority (NRA), is a national institution responsible for the regulatory procedures governing vaccine lot release and subsequent confirmatory testing, to ensure that all vaccines released for use within a country are safe, effective and of good quality.
National Immunization Technical Advisory Groups (NITAGs) are national advisory bodies responsible for strengthening evidence-based, locally-relevant policy and strategy decisions on issues of vaccine quality and safety, including the introduction of, or need for, new vaccines and immunization technologies.