The monitoring of possible adverse events caused by vaccines is a necessary measure in any case, either for emergency use or definitive use.
Every vaccine that reaches the Brazilian market and goes through the registration and authorization process of the National Health Surveillance Agency (ANVISA), begins a new stage: monitoring of possible adverse events caused by them. Therefore, the laboratories must present detailed Risk Management Plans.
This step is extremely important because the vaccinated population will be much larger than the clinical trial population, which has different profiles. Therefore, new data related to vaccine safety and efficacy may emerge. Monitoring is mandatory for ANVISA to be informed about any unfavorable and unwanted signs, symptoms or diseases temporarily associated with the vaccine.
The monitoring of safety and efficacy is done by the Pharmacovigilance area of the Agency, which acts to verify whether the benefits related to the use of medicines, such as vaccines, remain present after the product enters the market. In addition, ANVISA maintains communication with other regulatory agencies in the world, and also with the World Health Organization (WHO), to monitor risks and adverse events that occur in other countries that may have an impact in Brazil.
RISK MANAGEMENT PLAN:
Laboratories that hold vaccine registrations in Brazil must submit the Risk Management Plan (RMP) to the ANVISA. This document must be prepared and presented at the time of sanitary registration, and must contemplate:
I – safety specifications and exposure data from non-clinical, clinical and post-marketing studies;
II – epidemiological data, containing information from the population likely to be exposed to the product (target population) and the relevant comorbidities in that population;
III – description of the pharmacovigilance activities to be developed by the drug registration holder (DRM);
IV – description of the potential and identified risks contemplated in the safety specification, as well as the respective pharmacovigilance measures proposed to monitor them;
V – description of specific measures to present missing critical information;
VI – forecast of information collection, in addition to the planned studies, with the objective of increasing the knowledge of product safety, when the DRM deems necessary;
VII – description of the additional actions proposed for the minimization of risks in pharmacovigilance, when applicable; and
VIII – description of the safety actions adopted by the DRM, resulting from regulatory measures taken by foreign health authorities, when applicable.
VACCINES AGAINST COVID-19:
Prioritization of notifications related to Covid-19 vaccines will be performed through VigiMed, the Anvisa system in partnership with the Uppsala Monitoring Centre (UMC1), for notification of adverse events to drugs and vaccines. Agency technicians will follow up daily the entries in the system, treating with priority the cases related to the new coronavirus. When there is evidence of an adverse event, the analysis and investigation will be performed.
1The UMC is a WHO-linked center that operates the International Drug Monitoring Program.
About Global Regulatory Partners
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