Washington, D.C., 19 August 2022 (PAHO) - The Pan American Health Organization (PAHO), with the support of the regulatory authorities of the Region of the Americas, has adapted the World Health Organization (WHO) protocol for safety surveillance of molnupiravir, by cohort event monitoring. Molnupiravir is an oral medication for mild and moderate COVID-19 in adults at risk of hospitalization and progression to severe illness. It is the first oral medicine on the market for the treatment of non-severe COVID-19.
The protocol is designed to investigate the safety of molnupiravir in people over 18 years of age through the monitoring of adverse events. This information may be taken into consideration by national regulatory authorities (NRAs) when granting full marketing authorization or making other regulatory decisions.
The safety surveillance protocol of molnupiravir in the Region is an adaptation of a WHO proposal. It was developed within the framework of the activities of the network of pharmacovigilance focal points and the NRA group for vaccine safety, based on the regional plan for the introduction of COVID-19 vaccines. Participating NRAs contributed to the proposed adaptations.
The primary objective of the study is to characterize and estimate the incidence of adverse events of special interest (AESI), including serious adverse events (e.g., hospitalizations) among patients who receive the medicine. Also, participating patients will be advised on treatment through educational materials developed by PAHO for this target audience, with a view to increasing rational use of the medicine and preventing potential exposure during pregnancy.
This initiative is part of the project "Working together to fight antimicrobial resistance", implemented with support from the European Union, in collaboration with the Food and Agriculture Organization of the United Nations (FAO) and the World Organization for Animal Health (OIE).