Training held on monitoring of Covid immunisation affects

Islamabad:The Drug Regulatory Authority of Pakistan (DRAP), in collaboration with World Health Organisation, arranged a one-day training session on monitoring of Adverse Event Following Immunisation (AEFI) of COVID-19 vaccine here on Monday.

Representatives from the Pakistan National Pharmacovigilance Centre (PNPC), DRAP, federal and provincial Expanded Programmes on Immunization, and focal persons of pharmacovigilance from the provinces attended the training.

Dr. Abdur Rashid, Director, Division of Pharmacy and Head of PNPC welcomed the participants. He briefly explained the role of DRAP in general and the Division of Pharmacy Services in particular in the process of approval of clinical trials of COVID-19 vaccines in Pakistan and subsequent monitoring of AEFIs after their registration. He also explained the role and responsibilities of each stakeholder.

The CEO of DRAP Asim Rauf informed that the Registration Board of DRAP has granted emergency authorization to three COVID-19 vaccines. However, the safety of these vaccines can never be comprised, which is why the training session has been arranged to strengthen the procedures and tools for collection of AEFI and to enhance coordination among different stakeholders. He also informed that safety monitoring will not only help monitor the harms of COVID-19 vaccine, but will also build public trust for smooth vaccination.

Acting country head of WHO Macheal Ukiwa appreciated the efforts of DRAP in granting emergency use authorization to three COVID-19 vaccines. He said, these vaccines are new and there are chances that there might be rumors and fake news about vaccine safety. “The purpose of todays' session to counter such fake news and rumors. It is the responsibility of WHO to optimize the health of Pakistani population and to minimize the risks associated with treatment options. The WHO will continue to support activities aimed at ensuring patient and public safety,” he stated.

Aqsa Hashmi, Assistant Director at PNPC explained the procedures of reporting. The participants were informed and trained about different methods of reporting such as reporting through e-reporting system and MedSafety mobile application. MedSafety App was installed in the mobiles of participants, and hands-on training was imparted.

Abdul Mateen, Assistant Director and focal person for pharmacovigilance, focused on VigiFlow data entry of AEFI and ADRs. Participants were provided hands-on training on data entry in VigiFlow and how to use MedDRA and WHO drug for coding of ADRs/AEFIs and drugs/vaccines. Furthermore, the way forward for reporting of AEFI was also discussed; AEFI reports will be submitted by AEFI focal person to DHO office on a daily basis. The data will accordingly be entered in the EPI-MIS, which will share it with DRAP through VigiFlow.

In the last session of the training, the EPI explained their system of AEFI surveillance. The participants were told that COVID-19 vaccination will be carried out through Adult Vaccination Counters (AVCs) established at 582 health facilities across the country. All AVCs will have AEFI focal persons who will share AEFI data with the DHO office on a daily basis. The AEFI review committee at the national level will supervise the activities related to AEFI. Final data of AEFI will be shared with PNPC through VigiFlow.

The session concluded with a pledge to actively monitor AEFI and report the same to concerned stakeholders in order to detect the risk as early as possible. The need to strengthen the coordination mechanism between different stakeholders was also underlined. It was decided that PNPC will provide necessary logins of VigiFlow database to Federal EPI for data entry and sharing of AEFI data with DRAP.