EMA publishes safety monitoring plan and guidance on risk management planning for COVID-19 vaccines

1st December 2020

EMA and the national competent authorities (NCAs) in EU Member States have prepared a  safety monitoring plan for COVID-19 vaccines . The plan outlines how relevant new information emerging after the authorisation and uptake of COVID-19 vaccines in the pandemic situation will be collected and promptly reviewed.

The safety of COVID-19 vaccines will be monitored according to the guidance set out by EMA and NCAs in the good pharmacovigilance practices (GVP), that applies to all medicines. In view of the extraordinary circumstances, though, EU authorities have planned several activities that will apply specifically to COVID-19 vaccines.

Through the implementation of these activities, the EU medicines regulatory network will assess any safety data emerging from a range of different sources (spontaneous reporting, observational studies, etc.). Any potential safety concerns identified will be addressed by taking appropriate regulatory action to safeguard individual and public health and communicating with the public in a transparent and timely manner.

The plan comprises new reporting obligations for companies that will have to submit monthly safety reporting summaries in addition to the regular updates foreseen by the legislation. Furthermore, the plan details the scientific studies already in place to monitor the safety, effectiveness and coverage of COVID-19 vaccines after their authorisation. Lastly, it details the exceptional transparency measures set up by EMA as well as how the Agency plans to engage with a wide range of stakeholders.

In this context, EMA has also published guidance to support pharmaceutical companies’ preparation of risk management plans (RMPs) for COVID-19 vaccines . As for any medicine, companies applying for a marketing authorisation for COVID-19 vaccines must submit RMPs. The RMP explains how the company must monitor and report on the safety of the vaccine once authorised, and what measures it must put in place to further characterise and manage risks. RMPs are updated as new information becomes available. The RMP guidance for COVID-19 vaccines complements the existing guidelines on the RMP format in the EU and guidance on good pharmacovigilance practices, which apply to all medicines. Additional specific considerations in this guidance address, for example:

• further information on vaccine safety that might be generated after the marketing authorisation in special populations, such as the elderly, children, or patients with co-morbidities;
• core requirements for lists of adverse events of special interest (AESI), methods used for signal detection, and follow-up of any safety signals identified in clinical trials;
• submission of monthly summary safety reports by marketing authorisation holders to EMA in addition to the usual periodic safety update reports;
• traceability tools that can help record who has received which vaccine and from which batch. 

All activities that companies include in the RMP for a COVID-19 vaccine should take into account EMA’s infrastructure to support the monitoring of the efficacy and safety of COVID-19 treatments and vaccines when used in day-to-day clinical practice. 

All RMPs¹ for COVID-19 vaccines will be published on the EMA’s website. This is part of EMA’s exceptional measures to maximise the transparency of its regulatory activities on medicines for treatment and prevention of COVID-19.

The documents published today will be updated once new information on the COVID-19 pandemic relevant for vaccine safety becomes available.

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¹ Full body of the RMP and Annex 4.

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