First phase: October 2020 - March 2021
Objetive:
Provide technical support on the regulatory processes for the adequate introduction and safety surveillance of COVID-19 vaccine and other related medicines.
5
National Regulatory Authorities participating
15
Work sessions
Elaborated resources
- Risk Management Plans and Periodic Safety Reports for COVID-19 Vaccines: Recommendations for Their Request, Preparation, Management, and Assessment
- COVID-19 Vaccine Pharmacovigilance Dashboard
- Consultation Document for Case Definitions: Adverse Events of Special Interest and Adverse Events Following Immunization during COVID-19 Vaccine Introduction
- Recommendations on Regulatory Processes and Aspects related to the Introduction of Vaccines during the COVID-19 Pandemic and Other Emergencies
Second phase: March 2021 to present
Objetive:
Support the safety surveillance of COVID-19 vaccines and other related medicines.
11
National Regulatory Authorities participating
30
Work sessions
Elaborated resources
- Consolidated information on AEFI and serious AEFI against COVID-19 applied to the Region of the Americas.
- Joint evaluation of Risk Management Plans of COVID-19 vaccines.
- Adaptation of the World Health Organization (WHO) protocol for safety surveillance of molnupiravir and implementation in participating countries.
- Analysis of the safety information of Covid-19 vaccines used in the Region.
- Protocol elaboration for the regional vigilance of nirmatrelvir and ritonavir.