Team Blitz India
NEW DELHI: While COVAX provided vaccines to eight countries, nine countries used bilateral deals to procure vaccines. Countries such as Australia, Bulgaria, China, Croatia, India, Japan and the USA also donated vaccines to Member States. WHO worked with countries to ensure that national-level authorisation and appropriate SOPs for use of these vaccines were in place.
Unlike the process for vaccine introduction into routine immunisation (RI), the Covid-19 pandemic required accelerated vaccine production and deployment of multiple types of vaccines based on the mRNA platform. Multiple vaccines needed to be used within individual Member States at the same time. The use of new vaccines required national EUA in each Member State.
Apart from the vaccine manufacturing countries of India, Indonesia and Thailand, which have a high level of regulatory maturity categorised as level 3+, the NRAs of many Member States lacked national-level policies on EUA or new vaccine usage. As the vaccine roll-out for Covid-19 was introduced almost a year into the pandemic, WHO and partners worked with national governments to pre-empt and address issues of regulatory preparedness during the approximately year-long period between the outbreak of the pandemic and vaccine rollout.
Building capacities
WHO worked with the NRAs of Member States to develop regulatory frameworks on EUA, build the legal and procedural capacities of the teams, and create SOPs before the vaccines were manufactured to avoid legal and procedural delays in vaccine deployment. Through dialogues and discussions, WHO also ensured that the manufacturing countries did not engage in vaccine nationalism and access to vaccines was not delayed due to export-import restrictions.
Building the capacities of NRAs was crucial for the swift uptake of vaccines in the region through accelerated authorisation and establishment of SOPs for each vaccine. Now that the pandemic has ended, WHO is working with Member States to convert the legal status of the vaccines from EUA to market use authorisation (MUA).
Response experiences
Multiple vaccines: Myanmar received six different Covid-19 vaccines (AstraZeneca, Covaxin, Sinopharm, Sinovac, Sputnik Light and Myancopharm) across 30 shipments, with each shipment varying in size from 0.1 to 6.7 million doses in just 13 months. Health staff across the system needed to be prepared for handling, administration and contingent situations arising in case of AEFI. This caused a need for repeated logistical arrangements, which also taxed the health system.
Approval delays: As Maldives did not have a policy for new vaccines that were not under WHO EUL or PQ, there were delays in approval and acceptance of Covishield, the first vaccine to receive EUA in the country. Delays also occurred due to the lack of available documents online or in English, as was the case during the EUA of Sinopharm.
