Posted on November 13, 2020 | Through
As it continues its ongoing review of COVID-19 vaccine candidates, the European Medicines Agency (EMA) presented its COVID-19 vaccine safety monitoring plan. In addition to the agency’s usual vaccine surveillance requirements, the surveillance plan imposes new monthly reporting obligations on companies marketing vaccines.
A new guide is also available to help companies in the details of developing vaccine risk management plans (RMP) specific to COVID-19.
In collaboration with the national competent authorities (NCAs), the EMA is requiring Pharmaceutical companies that market licensed COVID-19 vaccines to step up data collection and reporting activities, to include active data collection for serious adverse events that may occur infrequently. Companies should also use spontaneous reporting systems and observational studies, among other data sources, to research and assess emerging safety data.
With this information in hand, says the EMA, companies should look to “[p]comprehensive assessment of the impact of safety issues detected on the benefit-risk ratio of vaccines, taking into account exposure and efficacy data.
Vulnerable populations such as pregnant women and the elderly should benefit from enhanced active surveillance, and the plan should include a way to engage with stakeholders, including those who have been vaccinated and those working in health, as well. as marketing authorization holders (MAHs) and their international partners.
All relevant 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 biannual periodic safety update reports (PSUR) required by good pharmacovigilance practices (GVP), MA holders must submit monthly summary reports. These reports should include “information on suspected adverse reactions reported, including adverse events of special interest (AESI) and sales data,” as well as other data, the EMA said.
Aggregated exposure data for each vaccine should be available for detection of safety signals and ongoing analysis of vaccines for particular populations, among others. The EMA also requires that MAHs have a traceability tool so that the vaccine and the lot are known for each individual vaccinated.
The accompanying core RMP19 advice was added as a result of EMA guidelines on the development and deployment of the COVID-19 vaccine. During a series of modules in the guide, MAHs are given guidance to flesh out the details of the RMP, including considerations for safety specifications, identification of identified significant risks, special populations for enhanced surveillance and a reactogenicity monitoring plan.
Where vaccine formulation and administration may affect the risk of adverse events, these details should also be addressed in the RMP.
Other topics not required but offered for consideration include the risk of vaccination errors that could occur in a mass vaccination scenario, what happens when individuals receive a mixed schedule of two different vaccines, and the need booster or revaccination.
The pharmacovigilance plan should include details of signal detection, including plans to “leverage the infrastructure and outcome of global efforts” to enumerate adverse events. The guide also provides details on the recommendations of the follow-up questionnaire.
Whether additional pharmacovigilance is required in addition to routine postmarketing safety activities will depend on a variety of factors, depending on the recommendations: missing information or whether, in addition to ongoing or planned clinical trials, a study Post-Authorization Safety Observational (PASS) is required.
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