Aimed at integrating COVID-19 pandemic vaccines with national immunisation programmes in countries of the World Health Organization’s South-East Asia Region, vaccine regulators and officials from the WHO on Tuesday began deliberating strategies for member countries to transition from the use of COVID-19 vaccines under Emergency Use Authorisation (EUA) to full Marketing Authorisation (MA).
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“Even though the acute phase of the COVID-19 pandemic is over, the virus is still circulating. We need to make sure people continue to stay protected from existing and future variants. For this, it is crucial that the regulatory authorities of member states are better equipped to take considered decisions to grant long-term authorisation to COVID-19 vaccines, and introduce them in national immunisation programmes as per requirements,” Poonam Khetrapal Singh, Regional Director, WHO South-East Asia said at the start of the three-day regional workshop on ‘Conversion of Emergency Use Authorisation (EUA) to full Marketing Authorisation (MA) for pandemic vaccines including COVID-19’, organised by the WHO in Kathmandu, Nepal.
At the meeting, members of the National Regulatory Authorities (NRA) and National Control Laboratories (NCL) of member countries, and experts from the WHO and the Therapeutic Goods Administration (TGA), Australia are set to deliberate key considerations in meeting regulatory requirements and licensing regulations for the pandemic vaccines.
The WHO South-East Asia Region office noted that multiple COVID-19 vaccine products were developed following unprecedented global collaboration to facilitate their availability during the health emergency, and most national regulatory agencies established EUA for COVID-19 vaccines based on the WHO’s Emergency Use Listing (EUL).
Since their introduction, over 3.35 billion COVID-19 vaccines have been administered in 10 member countries of the WHO South-East Asia Region under the EUA mechanism. Converting EUA to MA for COVID-19 vaccines is expected to be based on full analysis of clinical data with a longer period of follow-up. It will also provide the most updated technical data on vaccines and their efficacy, and provide updates on stability profiles, the WHO’s regional office said.
Earlier this month, the WHO released a roadmap on the use of COVID-19 vaccines, which aims to address evolving public health needs at the present time, with Omicron and its sub-lineages dominating circulation globally. In the context of high population-level immunity, using a base case scenario assumes the virus will continue to evolve but cause less severe disease, with a possible surge in infections requiring booster doses to protect high priority groups.
