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

Photo by Daniel Schludi on Unsplash

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.

FDA Guidance on AE Reporting during a Pandemic

ATTENTION !!
This post was updated on 20-May-2020 to reflect the changes brought by the revised version of the Guidance Document published by the FDA on 11-May-2020. Resulting revisions are tracked (in Red & Highlighted in Yellow).



The U.S. FDA has published a new Guidance Document on 19-Mar-2020, which is entitled : “Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During a Pandemic”.

This is not exactly a new document and in reality, this represents a minor revision of the 2012 guidance on “Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic". The update clarifies that the guidance is applicable to any pandemic, including the current COVID-19 pandemic and not just an influenza pandemic.

Possible Impact of a Pandemic

This guidance provides recommendations to address the anticipated workforce shortage that can result from high absenteeism in the Industry and at the FDA during a pandemic, while the volume of case reports may increase due to the widespread use of medical products to face the pandemic.

Although compliance should be maintained to the maximum extent possible, the guidance brings flexibility to prioritize AE reporting responsibilities when resources become insufficient, which should be considered in Business Continuity arrangements.

Business Continuity and Prioritization

Companies that are unable to fulfill normal adverse event reporting requirements during a pandemic should maintain documentation of the declaration of a pandemic (e.g. by the WHO), and of the factors that are preventing the firm to comply with its reporting requirements, i.e. high absenteeism and/or increase in caseload. The FDA should be notified as soon as possible.

In these circumstances, the FDA will accept that certain safety reports are not submitted within the regulatory timeframes provided that delayed reports are submitted within 6 months of the restoration of AE reporting capabilities to their pre-pandemic state. However, a different timeframe may be set by the FDA (see Section D of the Guidance Document).

FDA defines Priorities for Safety Reports

The guidance includes a table that defines which reports companies should submit and which may be stored if necessary. Here is a summary for approved drug and biological products (NDA, ANDA, or BLA):

• FDA will communicate with firms if there are products and issues that present special concerns, in which case full compliance with expedited and periodic reporting requirements is expected.
• For all other products, Periodic Safety Reporting may be suspended.
• Regarding Expedited Safety Reporting (i.e. 15-day Alert reports), while other reports may be stored if necessary, the following reports should be submitted within required timeframes:

1-	Reports associated to products approved for an indication related to the pathogen causing the pandemic, including pandemic vaccines targeting the pathogen or the disease, whether or not this use is included in the approved labeling
2-	Reports associated to products approved within prior three years
3-	For Biologics only All Products, Reports with a Fatal Outcome

Besides these rules for approved drug and biological products, the table provides guidance for other types of products, including Prescription drug products marketed without an approved NDA (including compounded or repackaged products), Medical Devices, Blood Products, Human Cells, Tissue, and Cellular and Tissue-Based Products (HCT/P), etc.

→       Link to FDA Guidance Page

→       Direct link to FDA Guidance Document

_______________________________________

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.