EMA’s Pharmacovigilance plan for Covid-19 vacccine

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.

Once COVID-19 vaccines are authorised is anticipated to be very high which may lead to a high volume of suspected adverse reaction reports and other safety data. Thus, the prompt detection and evaluation of new information on the benefit-risk balance of these vaccines, timely communication
and a high level of transparency will be key to protect public health and ensure the public’s trust in the vaccines and in the regulatory system.

This safety monitoring plan is to ensure that all new information collected post-marketing promptly reviewed and any emerging new information to be shared with the public in a timely manner.

The main objectives of this plan include:

• Active collection of data on rare potential risks;
• Rapid detection, prioritisation and assessment of emerging safety information derived from spontaneous reporting systems, observational studies and other data sources;
• Prompt evaluation of the impact of detected safety issues on the benefit-risk balance of the vaccines, taking into account exposure and effectiveness data;
• Active surveillance of vulnerable populations, such as pregnant women and older vaccinees;
• Engagement and collaboration with stakeholders including vaccinees and healthcare professionals, marketing authorisation holders (MAHs) and international partners;
• Prompt and effective communication of new information arising from the above activities.

As per EMA, “The legal provisions on pharmacovigilance and the extensive guidance developed by EMA in collaboration with NCAs set out in the good pharmacovigilance practices (GVP), apply to all medicinal products authorised in the EU, including COVID-19 vaccines. This safety monitoring plan focusses on the activities planned specifically for COVID-19 vaccines. The established processes and requirements for pharmacovigilance in general are briefly noted where relevant to provide context.”

Refer below link for details and sublinks from EMA, Safety monitoring plan