EMA Risk Management approach for COVID-19 vaccines

Further to the recent good news regarding the efficacy of COVID-19 vaccine candidates, European Authorities have published new guidance documents to support Risk Management activities for these vaccines once they are authorised.

    ⇒    Link to EMA News Release

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CoreRMP19 requirements and guidance

This includes a new guidance document published by the EMA to help companies prepare the Risk Management Plan (RMP) for their COVID-19 vaccines, which complements the existing GVP Guidelines and the associated RMP template. This document covers specific considerations for COVID-19 vaccines, including:

• The submission by MAHs of Summary Monthly Safety Reports to the EMA, to complement PSURs. As detailed within the guidance, these reports should include interval and cumulative summary tabulations of ADR reports, exposure data, ongoing and closed signals, etc.
• The need to adapt signal detection methods and practices to the expected large volume of ADR reports in the context of vaccination campaigns during a pandemic
• The need to consider global efforts to define the list of Adverse Events of Special Interest (AESIs)
• The need to consider the use of specific Follow-up Questionnaires for reports of identified safety concerns and suspected AESIs, while the burden on healthcare professionals should remain limited
• The need to consider missing information for specific populations, including pregnant women, patients with co-morbidities, elderly and children

   ⇒    Direct link to Core RMP guidance for COVID-19 vaccines

Please Note that a revision of the above guidance was published on 15-Jun-2021.

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Pharmacovigilance Plan of the EU Regulatory Network

European Authorities have also produced a Safety Monitoring Plan for COVID-19 vaccines, which outlines how they intend to collect and review all relevant information once COVID-19 vaccines get authorised.

In addition to the EU GVPs, several activities will apply specifically to COVID-19 vaccines. As described above, this includes new reporting obligations for companies, who will be required to submit Summary Monthly Safety Reports to the EMA.

Transparency is an important theme of the plan, and it details the exceptional measures set up by the EMA to support public confidence and promote the uptake of COVID-19 vaccines. As an example, the EMA will publish on its website the full body of the RMP for all authorised COVID-19 vaccines, including Annex 4 presenting specific ADR follow-up forms.

    ⇒    Direct link to Pharmacovigilance Plan of the EU Regulatory Network

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Thierry Hamard is a Pharmacist with more than 15 years of Global Pharmacovigilance Auditing experience and over 200 PV Audits performed since his company PV Focus was established in 2004.

Thierry is also Chief Editor of Safety Observer, a provider of Regulatory Intelligence services for Pharmacovigilance since 2005.