Overview
A five-day regional workshop on “Lot release of COVID-19 vaccines” was conducted in Kasauli, India from 10 to 14 October 2022 by the Communicable Diseases Department – Immunization and Vaccine Development (IVD) of the WHO Regional Office for South-East Asia in coordination with the Central Drugs Laboratory (CDL) for vaccine testing in India. It had participants from national control laboratories (NCLs)/national regulatory authorities (NRAs)/ministries of health of Bangladesh, Bhutan, India, Indonesia, Maldives, Nepal, Sri Lanka, Thailand and WHO Country Office Nepal. Experts from the Therapeutic Goods Administration (TGA), WHO headquarters and WHO Country Office Bangladesh attended the workshop virtually.
During the working group’s meeting of the South-East Asian Regulatory Network (SEARN) in January 2022, participating NRAs had requested support on COVID-19 vaccines. Three main needs were highlighted:
- the need to discuss regulatory hot topics related to COVID-19 (such as how to transition from emergency use authorizations to full marketing authorizations);
- the need to advocate integration of adverse events following immunization (AEFI) into the vigilance system; and
- the need for capacity-building through training of laboratory technical staff in testing and lot release of COVID-19-related products (e.g. mRNA platforms or diagnostics).
The WHO Regional Office for South-East Asia (Health System Development [HSD] and IVD) is conducting a series of meetings, trainings and workshops for regulation of all COVID-19-related medicinal products including vaccines and in vitro diagnostics to address the above needs. This regional lot release workshop was part of this larger programme of activities, which aimed to address the third need for capacity-building of laboratory technical staff.
The objectives of the workshop were:
- to strengthen capabilities of NCL and NRA staff to carry out independent lot release of COVID-19 vaccines when the vaccine has full marketing authorization in the country
- to efficiently review the lot summary protocols of all types of COVID-19 vaccines to deliberate on policies and approaches in the Region for testing and lot release of COVID-19 vaccines
- to prepare a plan for participation in international harmonization exercises for testing of COVID-19 vaccines and a roadmap for regional NCLs surrogacy plan for vaccine testing
- to explore the possibilities of developing regional working reference standards for certain COVID-19 vaccines for laboratory access of locally produced vaccines.
The five-day workshop had four technical sessions with presentations, discussions and group exercises and hands-on laboratory sessions and a field visit. The technical sessions had discussions on the progress made in COVID-19 Vaccine Deployment and Regulation and Linkages with Regional Vaccine Implementation Plan 2022–2026; WHO lot release guidelines and lessons learnt from the pandemic and modules on lot release management, NRA indicators and lot release procedure; summary lot protocol for COVID-19 vaccines and global experience sharing by TGA on lot release processes; and testing of imported and indigenously manufactured COVID-19 vaccines. The workshop had laboratory sessions on COVID-19 vaccines/conventional technologies at the CDL to better explain the laboratory access regulatory function to the participants. The participants were also taken on a field visit for sample collection, shipment preparation and tracking.
The final day of the workshop involved “report making for lot release finalization” incorporating case studies of lot release and test certificates. This was followed by a “course overview and follow-up actions”, which included future workshops and proposed trainings.
The participating NRAs/NCLs were requested to share certain experiential information with WHO for analysis and publication. The closing session of the workshop featured a post-workshop questionnaire and course evaluation.
