“The vaccine manufacturing and regulatory sectors have a critical role to play in equitable and efficient deployment of vaccines,” said Dr Poonam Khetrapal Singh, Regional Director, WHO South-East Asia Region, at the two-day virtual meeting that ended today.
The meeting deliberated processes and timelines to fast-track registration of COVID-19 vaccines in countries using the Emergency Use Listing procedures while comprehending the landscape of COVID-19 vaccine production in the Region.
Aimed at strengthening collaboration between national programmes, vaccine producers and regulators in the region for COVID-19 vaccine deployment, the meeting provided a platform for interaction and experience sharing for vaccine registration, deployment and regulation.
The Regional Director said all countries in the Region are now developing and finalizing national deployment and vaccination plans for COVID-19, of which regulatory preparedness is a core component.
Establishing expedited regulatory pathways for vaccine approval and adjusting regulatory pathways to the type of vaccine that is developed and filed for approval remains critical as emergency use authorization will precede full licensure, Dr Khetrapal Singh said.
While vaccine licensure systems may need to be modified, having standard operating procedures and stipulated timelines for emergency use authorization would be vital, she said.
The Regional Director emphasized on effective coordination, collaboration and information-sharing. From R&D to production, and from information on country readiness to post-marketing surveillance, manufacturers, regulators, policy-makers and planners must continue to work together to optimize and refine vaccine deployment.
“Countries in our Region are among the world’s largest vaccine manufacturers, and the vaccines produced here are likely to be administered to billions of people globally. I am certain that together, in solidarity with all people of the Region and world, you will effectively contribute to health and well-being of all,” Dr Khetrapal Singh said.
Key global and regional partners such as GAVI and UNICEF participated in the meeting. Among the vaccine manufacturers, from India Bharat Biotech International Ltd, Biological E Ltd, Cadila Healthcare Ltd, Serum Institute of India Pvt. Ltd, Dr Reddy’s Laboratories and Wockhardt Limited; from Indonesia Bio Farma Limited, and from Thailand Government Pharmaceutical Organization (GPO), Bionet Asia Co.Ltd and Siam Bioscience, participated in the meeting.
This was the second such meeting with vaccine manufacturers and regulators organized in WHO South East Asia Region, with the first held in April.
WHO has been supporting Member countries of the Region prepare for COVID-19 vaccines. A special session of the WHO South-East Asia Regional Immunization Technical Advisory Group was organized in November. The expert group made a series of recommendations including a fast tracking of the development of national deployment and vaccination plan, the application of guidelines provided by the ‘Values framework for the allocation and prioritization of COVID-19 vaccines’ and the ‘prioritization roadmap’ to identify priority populations and ensuring equity in delivery of COVID-19 vaccines, especially during the early stages when vaccine supply is expected to be limited.
The expert group also recommended that all countries should ensure availability of high-quality, complete and timely COVID-19 surveillance data on all risk groups, including migrants and remote or displaced populations, for decision-making related to vaccination.
While establishing collaboration with other health programs and sectors for optimum delivery of vaccine, countries should also leverage their experience in vaccine delivery platforms for adults, including experience with seasonal and pandemic influenza vaccination and Measles and Rubella and Japanese Encephalitis vaccination campaigns, to find effective ways to reach eligible adults with COVID-19 vaccines.
Adjustments should be made to vaccination strategies in accordance with the COVID-19 prevention measures and plans developed for demand generation, community engagement and risk communication, with special consideration for overcoming vaccine hesitancy. Countries should leverage the use of existing networks, including those for polio, to support the deployment of COVID-19 vaccines where appropriate.
The expert group highlighted the need for all countries to assess available cold chain space and meticulously plan cold chain requirement, including necessary improvements in storage, stock management, vaccine delivery strategy and waste management.
Earlier, WHO organized a meeting of cold chain managers of countries of the South-East Asia Region to help assess cold chain needs, identify gaps and plan for appropriate measures.
At the global level since April, the ACT-Accelerator partnership, launched by WHO and partners, has supported the fastest, most coordinated, and successful global effort in history to develop tools to fight COVID-19. Its vaccine pillar - COVAX - is co-led by WHO, Gavi and the Coalition for Epidemic Preparedness Innovations. It aims to accelerate the development and manufacture of COVID-19 vaccines, and to guarantee fair and equitable access for every country in the world.(*)