An integrated WHO Pharmacovigilance team was established in 2020, to combine work related to the safety of medicines and vaccines within the Department of Regulation and Prequalification (RPQ). Following this transformation WHO convened a joint meeting with both the Advisory Committee on Safety of Medicinal Products (ACSoMP) and the Global Advisory Committee on Vaccine Safety (GACVS) for the first time on 14-16 June 2022. A summary of the presentations and recommendations from the vaccine-specific sessions and from sessions of common interest for the pharmacovigilance of both medicines and vaccines is provided below.
Active surveillance: methods and data management tools
Molnupiravir, the first oral treatment for non-severe COVID-19, received a WHO conditional recommendation for use on 3 March 2022. One of the conditions of the recommendation was that there should be a robust, active pharmacovigilance programme in countries using this product. To respond to this requirement, in March 2022, WHO published a protocol for cohort event monitoring (CEM) studies for molnupiravir in low- and middle-income countries (LMICs). The plan for the implementation of the protocol in between 6 to 12 countries, which consists of developing a training programme, and data collection, management and transfer tools, was shared with the Committees. WHO has started developing the data collection and management tools. The tools will be useable in studies assessing other treatments, and vaccines, even in clinical trials. Data will come from diverse sources, and at various times throughout the monitoring period. Information technology (IT) solutions are needed for study participants and study site staff as well as principal investigators. In addition, as the study will be done in several countries, the IT solutions need to be available in different languages and be adaptable to the local context.
It was recommended that case report forms (CRFs) should be adapted to include the gestational age at time of exposure for the baby, when following pregnant women who were inadvertently exposed to the medicine, particularly since the exposure time is short. Also, the CRFs should be adapted to prompt participants to report concomitant use of over-the-counter medications.
Monitoring safety in pregnancy
WHO has 3 ongoing initiatives to improve safety monitoring during pregnancy. The first is a collaborative project between the Pharmacovigilance team and PATH aiming to map and assess the strengths and limitations of pregnancy exposure registries available in LMICs. The second is an internal WHO project, to map various WHO initiatives to assess the availability of minimal data elements to study pregnancy and neonatal outcomes in LMICs and to propose methods to harmonize these data elements. The third project is the monitoring of the safety of COVID-19 vaccines during pregnancy, which is a collaboration with the WHO Sexual and Reproductive Health and Research team.
An Expert Steering Committee (ESC), set up to oversee the first 2 projects, will provide independent, authoritative, and scientific advice to WHO on the safety of health interventions in pregnancy, and for the implementation of pregnancy exposure registries and other methods for monitoring the safety in pregnancy in LMICs. This...