PMID- 36811813
OWN - NLM
STAT- MEDLINE
DCOM- 20230420
LR  - 20230514
IS  - 1179-1942 (Electronic)
IS  - 0114-5916 (Print)
IS  - 0114-5916 (Linking)
VI  - 46
IP  - 4
DP  - 2023 Apr
TI  - Adverse Events to SARS-CoV-2 (COVID-19) Vaccines and Policy Considerations that 
      Inform the Funding of Safety Surveillance in Low- and Middle-Income Countries: A 
      Mixed Methods Study.
PG  - 357-370
LID - 10.1007/s40264-023-01279-3 [doi]
AB  - INTRODUCTION/OBJECTIVE: Rapid global approval of coronavirus disease 2019 
      (COVID-19) vaccines and concurrent introduction in high-income countries and low- 
      and middle-income countries (LMIC) highlights the importance of equitable safety 
      surveillance of adverse events following immunization (AEFIs). We profiled AEFIs 
      to COVID-19 vaccines, explored reporting differences between Africa and the rest 
      of the world (RoW), and analyzed policy considerations that inform strengthening 
      of safety surveillance in LMICs. METHODS: Using a convergent mixed-methods design 
      we compared the rate and profile of COVID-19 vaccines' AEFIs reported to VigiBase 
      by Africa versus the RoW, and interviewed policymakers to elicit considerations 
      that inform the funding of safety surveillance in LMICs. RESULTS: With 87,351 out 
      of 14,671,586 AEFIs, Africa had the second-lowest crude number and a reporting 
      rate of 180 adverse events (AEs) per million administered doses. Serious AEs 
      (SAEs) were 27.0%. Death accounted for about 10.0% of SAEs. Significant 
      differences were found in reporting by gender, age group, and SAEs between Africa 
      and the RoW. AstraZeneca and Pfizer BioNTech vaccines were associated with a high 
      absolute number of AEFIs for Africa and RoW; Sputnik V contributed a considerably 
      high rate of AEs per 1 million administered doses. Funding decisions for safety 
      surveillance in LMICs were not based on explicit policies but on country 
      priorities, perceived utility of data, and practical implementation issues. 
      CONCLUSION: African countries reported fewer AEFIs relative to the RoW. To 
      enhance Africa's contribution to the global knowledge on COVID-19 vaccine safety, 
      governments must explicitly consider safety monitoring as a priority, and funding 
      organizations need to systematically and continuously support these programs.
CI  - (c) 2023. The Author(s).
FAU - Ogar, Comfort K
AU  - Ogar CK
AUID- ORCID: 0000-0003-0448-7111
AD  - Department of Global Health and Social Medicine, Harvard Medical School, Boston, 
      USA. kunacom@yahoo.com.
AD  - Utrecht Centre for Pharmaceutical Policy and Regulation, Division of 
      Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for 
      Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands. 
      kunacom@yahoo.com.
FAU - Quick, Jonathan
AU  - Quick J
AD  - Department of Global Health and Social Medicine, Harvard Medical School, Boston, 
      USA.
AD  - Duke Global Health Institute, Duke University School of Medicine, Durham, USA.
FAU - Gilbert, Hannah N
AU  - Gilbert HN
AD  - Department of Global Health and Social Medicine, Harvard Medical School, Boston, 
      USA.
FAU - Vreman, Rick A
AU  - Vreman RA
AD  - Utrecht Centre for Pharmaceutical Policy and Regulation, Division of 
      Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for 
      Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.
FAU - Mantel-Teeuwisse, Aukje K
AU  - Mantel-Teeuwisse AK
AD  - Utrecht Centre for Pharmaceutical Policy and Regulation, Division of 
      Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for 
      Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.
FAU - Mugunga, Jean Claude
AU  - Mugunga JC
AD  - Department of Global Health and Social Medicine, Harvard Medical School, Boston, 
      USA.
AD  - Partners In Health, Boston, USA.
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20230222
PL  - New Zealand
TA  - Drug Saf
JT  - Drug safety
JID - 9002928
RN  - 0 (COVID-19 Vaccines)
RN  - 0 (Vaccines)
SB  - IM
MH  - Humans
MH  - Adverse Drug Reaction Reporting Systems
MH  - *COVID-19/prevention & control
MH  - *COVID-19 Vaccines/adverse effects
MH  - Developing Countries
MH  - Policy
MH  - SARS-CoV-2
MH  - Vaccines/adverse effects
PMC - PMC9945828
COIS- Comfort K. Ogar received funds from Harvard University and the Ronda Stryker and 
      William Johnston MMSc Fellowship in Global Health Delivery to undertake the 
      research work as part of her master's thesis work. No funding support was 
      received for the writing of the manuscript. Jean Claude Mugunga, Hannah N. 
      Gilbert, Jonathan Quick, Rick A. Vreman, and Aukje K. Mantel-Teeuwisse declare no 
      conflict of interest.
EDAT- 2023/02/23 06:00
MHDA- 2023/04/20 10:17
PMCR- 2023/02/22
CRDT- 2023/02/22 16:00
PHST- 2023/02/06 00:00 [accepted]
PHST- 2023/04/20 10:17 [medline]
PHST- 2023/02/23 06:00 [pubmed]
PHST- 2023/02/22 16:00 [entrez]
PHST- 2023/02/22 00:00 [pmc-release]
AID - 10.1007/s40264-023-01279-3 [pii]
AID - 1279 [pii]
AID - 10.1007/s40264-023-01279-3 [doi]
PST - ppublish
SO  - Drug Saf. 2023 Apr;46(4):357-370. doi: 10.1007/s40264-023-01279-3. Epub 2023 Feb 
      22.