EMA rolls out COVID vaccine monitoring plan

Regulatory NewsRegulatory News | 13 November 2020 |  By 

As it continues its rolling review of COVID-19 vaccine candidates, the European Medicines Agency (EMA) has laid out its COVID-19 vaccine safety monitoring plan. In addition to the agency’s usual vaccine monitoring requirements, the monitoring plan imposes new monthly reporting obligations on companies marketing vaccines.
A new guidance is also available to assist firms in the specifics of developing COVID-19-specific vaccine risk management plans (RMPs).
Together with national competent authorities (NCAs), EMA is requiring pharmaceutical companies that market authorized COVID-19 vaccines to ramp up data collection and reporting activities, to include active collection of data for serious adverse events that may occur infrequently. Firms should also use spontaneous reporting systems and observational studies, among other data sources, to look for an assess emerging safety data.
With this information in hand, says EMA, firms should turn to “[p]rompt evaluation of the impact of detected safety issues on the benefit-risk balance of the vaccines, taking into account exposure and effectiveness data.”
Vulnerable populations such as pregnant women and older people should receive enhanced active surveillance, and the plan should include a way to engage with stakeholders including those vaccinated and those working in healthcare, as well as marketing authorization holders (MAHs) and their international partners.
All pertinent information should be reported, and pharmaceutical companies should have a plan for “prompt and effective communication of new information” arising from surveillance activities.  In addition to the required biannual periodic safety update reports (PSURs) required by good pharmacovigilance practice (GVP), MAHs will be expected to submit monthly summary reports. These reports should include “information on reported suspected adverse reactions, including adverse events of special interest (AESIs), and sales data,” along with other data, said EMA.
Aggregated exposure data for each vaccine needs to be available for safety signal detection and ongoing analysis of vaccines for special populations, among other purposes. EMA is also requiring MAHs to have traceability tool so that the vaccine and batch is known for each individual vaccinated.
The accompanying coreRMP19 guidance has been added to EMA’s suite of guidances on COVID-19 vaccine development and deployment. Over a series of modules within the guidance, MAHs are handed guidelines for fleshing out details of the RMP including considerations for safety specifications, identification of important identified risks, special populations for enhanced surveillance, and a plan to track reactogenicity.
Where formulation and administration of the vaccine may impact the risk of adverse events, such details should also be addressed in the RMP.
Other topics not required but offered for consideration include the risk for vaccination errors that could occur in a mass vaccination scenario, what happens when individuals would receive a mixed schedule of two different vaccines, and the need for boosters or revaccination.
The pharmacovigilance plan should include specifics about signal detection, including plans to “leverage the infrastructure and result of global efforts” to enumerate adverse events. The guidance also gives specifics about follow-up questionnaire recommendations.
Whether additional pharmacovigilance is required over and above routine postmarketing safety activities will depend on a variety of factors, according to the guidance:  “Considerations should be given whether routine activities will be sufficient to provide adequate data to further characterize important identified and potential risks and investigate missing information or if, in addition to ongoing or planned clinical trials, an observational post-authorization safety study (PASS) is required.”
EMA guidance
EMA pharmacovigilance plan


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Tags: coronavirus, EMA, EU

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