Please use this identifier to cite or link to this item:
https://www.arca.fiocruz.br/handle/icict/66167
COLLABORATION WITHIN THE GLOBAL VACCINE SAFETY SURVEILLANCE ECOSYSTEM DURING THE COVID-19 PANDEMIC: LESSONS LEARNT AND KEY RECOMMENDATIONS FROM THE COVAX VACCINE SAFETY WORKING GROUP
Author
Affilliation
Coalition for Epidemic Preparedness Innovations. Oslo, Norway.
WHO. Geneva, Switzerland.
Independent Advisor. Brussels, Belgium.
Epidemiology and Pharmacovigilance. Leuven, Belgium.
Coalition for Epidemic Preparedness Innovations. Oslo, Norway.
Independent Advisor. Zurich, Switzerland.
Sanofi Pasteur. Lyon, France.
CSL Seqirus. Maidenhead, UK.
Biovac Institute. Pinelands, Cape Town, South Africa.
WHO. Geneva, Switzerland.
Instituto Butantan. São Paulo, SP, Brasil.
Fundação Oswaldo Cruz. Instituto de tecnologia em imunobiológicos (Bio-Manguinhos). Rio de Janeiro, RJ, Brasil.
The Task Force for Global Health. Decatur, Georgia, USA.
WHO. Geneva, Switzerland.
Independent Advisor. Brussels, Belgium.
Epidemiology and Pharmacovigilance. Leuven, Belgium.
Coalition for Epidemic Preparedness Innovations. Oslo, Norway.
Independent Advisor. Zurich, Switzerland.
Sanofi Pasteur. Lyon, France.
CSL Seqirus. Maidenhead, UK.
Biovac Institute. Pinelands, Cape Town, South Africa.
WHO. Geneva, Switzerland.
Instituto Butantan. São Paulo, SP, Brasil.
Fundação Oswaldo Cruz. Instituto de tecnologia em imunobiológicos (Bio-Manguinhos). Rio de Janeiro, RJ, Brasil.
The Task Force for Global Health. Decatur, Georgia, USA.
Abstract
This analysis describes the successes, challenges and opportunities to improve global vaccine safety surveillance as observed by the Vaccine Safety Working Group from its role as a platform of exchange for stakeholders responsible for monitoring the safety of vaccines distributed through the COVAX mechanism. Three key elements considered to be essential for ongoing and future pandemic preparedness for vaccine developers in their interaction with other members of the vaccine safety ecosystem are (1) the availability of infrastructure and capacity for active vaccine safety surveillance in low-income and middleincome countries (LMICs), including the advancement of concepts of safety surveillance and risk management to vaccine developers and manufacturers from LMICs; (2) more comprehensive mechanisms to ensure timely exchange of vaccine safety data and/or knowledge gaps between public health authorities and vaccine developers and manufacturers; and (3) further implementation of the concept of regulatory reliance in pharmacovigilance. These aims would both conserve valuable resources and allow for more equitable access to vaccine safety information and for benefit/risk decision-making.
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