The country launch of the PROFORMA project & Baseline assessment (BLA) – Tanzania
The National Medicines Regulatory Authority (NMRA) in Tanzania, Tanzanian Food and Drug Authority (TFDA) and other relevant stakeholders such as the Public Health Programs (PHPs), Marketing Authorization Holders (MAHs), University Teaching hospital and Health facilities were assessed on their current pharmacovigilance system and infrastructure. The baseline assessment was done jointly with another EDCTP funded project called Pharmacovigilance in Africa (PAVIA). The aims of the assessment were to identify strengths, gaps, and pharmacovigilance capacity building priorities at a national level as well as to define the elements of a sustainable pharmacovigilance strategy and skills required to support the regulatory functions. The baseline assessment took one week: it started on 30th July with an in-country launch in which all the relevant stakeholders were present. During the launch, the two consortia (PROFORMA and PAVIA) highlighted the importance of pharmacovigilance and the aim of the projects including the different work packages. Training for data collectors was given. The assessment was from 31st July to 2nd August. On 3rd August, all the data collectors gathered to discuss preliminary findings and share experiences. In total, 19 institutions were assessed, this included TFDA, one university teaching hospital, 3 PHPs including the Neglected Tropical Diseases (NTD) and National Immunization and Vaccines Programme (NVIP) , 10 health facilities and 4 MAHs. This baseline assessment has been replicated in Ethiopia, Kenya, and Rwanda.
Vaccine safety- HPV vaccine in Tanzania
The HPV active surveillance training of the trainers took place on 9th and 10th August and it was well attended by Regional immunization and vaccination officers (RIVOs), District immunization and vaccination officers and healthcare workers. The aims of the training sessions were to explain the protocol to study team, familiarize data collectors with data collection tools (CRFs) as well as receive relevant feedback on the protocol and CRFs. During the training, the aims and methodology of the active surveillance studies were explained, followed by discussions about the data collection tools. Comments were welcomed, and relevant feedbacks were incorporated. Over 60 participants participated in the training.
Cohort Event Monitoring of MDA for prevention and control of Lymphatic Filariasis in Tanzania
During 6th to 10th August, data collectors were trained on the active safety and efficacy surveillance protocol for mass Albendazole and Ivermectin administration for prevention and control of Lymphatic Filariasis.
At present, fieldwork and data collection are ongoing. Approximately 4000 participants will be prescreened for LF using FTS kits, microscopy tests will be done for LF antigenemia positive participants. After the pre-screening phase, MDA will be given. All 10000 study participants will be followed for 7 days for the safety monitoring of MDA for LF (Ivermectin and Albendazole). For the effectiveness of the MDA drugs, LF antigenemia and microfilaria positive participants will be followed for up to one year.