EMA updates COVID-19 vaccine risk management plans to reflect variant safety
The European Medicines Agency (EMA) wants companies to provide safety information on additional strains or variants in an update to its guidance on risk management plans (RMPs) for COVID-19 vaccines. In the update, EMA also discourages sponsors from using passive surveillance to evaluate vaccine safety due to a lack of robustness in these methods.The plan should be read in conjunction with EMA guidance on good pharmacovigilance practices, including GVP Module V, Module VI and Module IX. It updates a RMP put in place last year. (RELATED: EMA rolls out COVID vaccine monitoring plan, Regulatory Focus 13 November 2020)
The aim of the RMP is to document the risk management system to identify and minimize the risks of medicinal products. This RMP specifically addresses safety risk of COVID-19 vaccines and includes a series of modules detailing where the safety information to be placed in the RMP.
The update reflects the agency’s concerns with additional strains or variants. For example, the update directs sponsors to place information on additional strains or variants in the overview section of the RMP. The guidance states that “if the RMP includes information on both the originally approved product and the product containing different/additional strains, the administrative details need to be presented individually in this section.”
This information should also be placed in the section on clinical trial exposure in the RMP’s Module S-III and Module S-VII. The update states that “if new safety concerns are identified following the change/addition of strains, this should be presented in this section and highlighted in the summary of safety concerns.”
The update also discourages the use of passive surveillance in monitoring vaccine safety. The guidance states that since “no design of an enhanced passive surveillance (EPS) was considered robust in the evaluation of the first four approved COVID-19 vaccines, PRAC [Pharmacovigilance Risk Assessment Committee] discourages the use of such surveillance methods and advises the applicants/MAHs to focus efforts and resources on other types of pharmacovigilance activities.”
In other areas, the update calls for vaccine cards to be given to recipients. These cards should contain the name of the vaccine, a reminder to retain the card, and to bring it back when receiving a second dose, as well as an optional QR code that links to the MAH website with additional information on product use and adverse event reporting information.
Companies are required to submit RMPs to EMA when applying for a marketing authorization. These plans include information on a medicine’s safety profile, how these risks can be prevented, and plans for studies to gain more knowledge of the safety and efficacy of the vaccine. These plans must be modified throughout the lifecycle of the medicine as new information becomes available.
EMA’s updated guidance on RMPs
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