Lessons Learned from Vaccine Safety Surveillance Efforts

Much has been learned about the need for vaccine safety surveillance through COVAX and other recent collaborative efforts. Here, we highlight three recent publications that share lessons learned in active vaccine safety surveillance (AVSS).

SARS-CoV-2 vaccine-related adverse events in Zimbabwe: The need to strengthen pharmacovigilance in resource-limited settings (Pharmacoepidemiology and Drug Safety)

This letter discusses various strategies for strengthening pharmacovigilance in Zimbabwe, a limited resource country, using tailored, robust reporting or other pharmacoepidemiological methods that systematically collect and analyze adverse events associated with the use of COVID-19 vaccines, identify signals or emerging problems, and communicate how to minimize or prevent harm.

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 (BMJ Global Health)

The Vaccine Safety Working Group (VSWG) of COVAX was formed in November 2020 with representatives and consultants representing multiple stakeholders, including Brighton Collaboration, Developing Countries Vaccine Manufacturers Network (DCVMN), International Federation of Pharmaceutical Manufacturers and Associations, WHO and Coalition for Epidemic Preparedness Innovations (CEPI). Its primary objectives were to act as an open source of information for vaccine developers, to resolve common vaccine safety cross-project questions and challenges at speed, and to facilitate coordination within the ecosystem to maximize impact. 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.

Landscape review of active vaccine safety surveillance activities for COVID-19 vaccines globally (Vaccine)

Through the COVID-19 Safety Studies project, researchers aimed to identify gaps in the regional availability of safety data for COVID-19 vaccines. The findings offer a step toward building vaccine safety surveillance capacity in low- and middle-income countries in preparation for the next pandemic. In the article, “Landscape review of active vaccine safety surveillance activities for COVID-19 vaccines globally,” published in the journal Vaccine, the researchers explain that many safety activities in LMICs go unpublished, suggesting that evidence of vaccine safety in published literature is incomplete. They also advise that further investment will be required to advance active vaccine safety surveillance (AVSS) capacities in LMICs to estimate the incidence of serious AEFIs and any attributable risks from vaccination.

Sources

Murewanhema G, Dzinamarira T, Madziva R, et al. SARS‐Cov ‐2 Vaccine‐Related adverse events in Zimbabwe: the need to strengthen Pharmacovigilance in Resource‐Limited settings. Pharmacoepidemiol Drug Saf 2022;31:379–80 DOI: 10.1002/pds.5393

Chandler RE, Balakrishnan MR, Brasseur D, Bryan P, Espie E, Hartmann K, Jouquelet-Royer C, Milligan J, Nesbitt L, Pal S, Precioso A, Takey P, Chen RT; COVAX Vaccine Safety Working Group. 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. BMJ Glob Health. 2024 Mar 7;9(3):e014544. doi: 10.1136/bmjgh-2023-014544. PMID: 38453518; PMCID: PMC10921508.

Shamaei Zadeh PA, Jaimes CV, Knoll MD, Espié E, Chandler RE. Landscape review of active vaccine safety surveillance activities for COVID-19 vaccines globally. Vaccine X. 2024 Apr 10;18:100485. doi: 10.1016/j.jvacx.2024.100485. PMID: 38655548; PMCID: PMC11035105.

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