Pharmacovigilance Preparedness for the launch of future COVID-19 vaccine(s)
A key and critical strategy in containing the COVID-19 pandemic is the rapid development of safe and effective vaccines. The vaccine development community has responded rapidly with over 120 COVID-19 vaccine candidates based on both traditional vaccine platforms
and completely new ones, including DNA and mRNA.
Acknowledging the unprecedented short timeframe for COVID-19 development, limited safety data will be available at the time of deployment. Consequently, more effort will be required by implementing countries on safety monitoring, in settings that are likely
be overburdened by the pandemic. The population targeted by the COVID-19 vaccine will differ from the usual scope of immunization programmes, and hence the launch will require dedicated strategies. Large-scale deployment is expected, over a short period of
time. Timely detection and management of safety concerns would be critical, to ensure safety of immunized populations, retain trust in the immunization programmes and on public health authorities.
The Committee considered the safety aspects of the COVID-19 vaccines in the pipeline, and made a series of recommendations on a pharmacovigilance preparedness plan, in the lead-up to the COVID19 vaccine(s) deployment in countries, and on key aspects of vaccine
safety to be monitored following vaccine deployment. The Committee advised the creation of ad hoc working groups to elaborate and implement the PV preparedness plan and to support the safety monitoring of the COVID vaccines for real world evidence.
Read more
|
