The European Medicines Agency (EMA) has laid out its COVID-19 pharmacovigilance vaccine safety monitoring plan, as it continues a rolling review of vaccine candidates.
The new monitoring plan imposes new monthly reporting obligations on companies marketing vaccines, in addition to the current vaccine monitoring requirements.
Companies which market authorised COVID-19 vaccines will need to enhance data collection and reporting activities, such as active collection of data for serious adverse events (SAEs). It is recommended that companies use spontaneous reporting systems and observational studies to identify and assess emerging safety data. Rapid evaluation of the impact of detected safety issues and effectiveness data will be critical in determining the benefit-risk balance of a COVID-19 vaccine.
The plan also recommends that vulnerable populations such as pregnant women and older people receive enhanced active surveillance, as well as those working in healthcare. All relevant information should be reported by marketing authorisation holders (MAHs) and they should have a plan for prompt and effective communication of new information arising from such surveillance activities.
MAHs will be expected to submit monthly summary reports in addition to the current biannual periodic safety update reports (PSURs) required by good pharmacovigilance practice (GVP). The monthly reports will need to include information on reported suspected adverse reactions, adverse events of special interest (AESIs), and sales data.
MAHs are also required to have a traceability tool in place so that the vaccine and batch number is known for each patient vaccinated.
A new guidance has also been published to assist firms in developing COVID-19-specific vaccine risk management plans (RMP). This guidance gives details of COVID-19-specific criteria which needs to be included in the RMP including considerations for safety specifications, identification of important identified risks, special populations for enhanced surveillance, and a plan to track reactogenicity. The RMP should also include specifics about signal detection. The guidance also gives recommendations about follow-up questionnaires.
To view the EMA’s pharmacovigilance plan, click here.
To view the RMP guidance, click here.
Refer back to the Regulis news page frequently for the latest updates on the changes to PV in light of the current pandemic.