New Delhi: The WHO has announced a new, parallel process for the development and emergency approval of COVID-19 vaccines and other medicines. This will significantly shorten the time it takes for these products to be accessible in low- to low-middle-income countries.
The WHO’s current recommendation development and prequalification (PQ) or Emergency Use Listing (EUL) assessment processes are being expedited for COVID-19 products. This has resulted in the listing of some antivirals several hours after the WHO published its recommendations for use. The new process will ensure that the development of recommendations and the PQ or EUL assessment are done in a synchronous and parallel manner, but still remain entirely independent processes.
This change will improve access to innovative health products in low- to low-middle-income countries. It will also address inequities in countries that rely on WHO recommendations for the use of these products. The integrity of the procedure will be maintained by the strict confidentiality of manufacturers’ information.
The new parallel process will be triggered whenever the WHO identifies the need for a new or revised recommendation. The target time for both the recommendation development process and the manufacturer’s dossier submission for PQ or EUL assessment will be within twelve months. This will be achieved by synchronizing the two processes and having a coordinated external communication of their outcome to the manufacturer and Member States.