Essential Medicines and Biologicals
Medicines and Health Technologies
Participants: Argentina, Brazil, Mexico, Panama y Venezuela, PAHO/WHO.
- Conduct post-marketing surveillance of adverse events supposedly attributable to vaccination or immunization associated with new vaccines introduced in the Region to collect data on their safety profile and act accordingly.
- One priority of the network is to monitor ESAVI related to the introduction of rotavirus vaccines and determine the magnitude and profile of adverse events, including rare events.
- Set up a reliable system with capable of identifying potential risks early on and sharing the information efficiently and in a timely manner.
- Develop a rapid alert system for reporting severe and unanticipated cases (do not include mild and moderate events). A list will be drawn up of known events to report.
- Issue recommendations for corrective measures as serious and/or unanticipated events are identified and verified. Provide documentation that the vaccine is not a risk factor for intestinal invagination in the reported cases. Make efforts in the medium term to monitor the effectiveness of the new vaccines.
- Support other countries that introduce the vaccines under network surveillance.
- Boost surveillance capacity at the national, regional and global level, reinforcing the complementarity of roles between the EPI and the NRA.
- The network should cover the distribution and uses of the vaccines in both the public and private sectors. Harmonize definitions (glossary).
Implementation of the Network:
- All entities involved in vaccine surveillance will participate at the country level. These institutions should interact and collaborate to reach a consensus on conclusions. There should be a commitment to coordination among the various participants.
- The countries should name a focal point for reporting adverse events to the network, in keeping with the roles established in the system of their respective countries.
- It is proposed that the reporting mechanism be the same one established and used to notify the Uppsala Center.
- The member countries commit to maintaining timely and regular communication. The measures to adopt on the basis of the network’s findings will be communicated and shared.
- The member countries commit to sending the data from adverse event reports on a regular basis as a condition for retaining their membership. The reports should be sent monthly to PAHO by the fifth business day of the month.
- Pursuant to the official procedures, PAHO will send the countries the report from the meeting through official channels, formally requesting that they specify the institution responsible for reporting the data to the network.
- The institution or focal point will send the network the data obtained through the surveillance system established and the information on producers provided by the surveillance system, taking care beforehand not to duplicate the data.
- Other countries may participation in the network of sentinel countries at their request or that of countries that are already members. The new members should meet technical requirements that guarantee a contribution to the network and have an operational surveillance system at the country level.
- SANEVA (safety of new vaccines) is suggested as the name for the network of sentinel countries.