Beyond the jab: A need for global coordination of pharmacovigilance for COVID-19 vaccine deployment

Denise Naniche¹, Peter Hotez², Maria Elena Bottazzi², Onder Ergonul³, J Peter Figueroa⁴, Sarah Gilbert⁵, Mayda Gursel⁶, Mazen Hassanain⁷, Gagandeep Kang⁸, David Kaslow⁹, Jerome H Kim¹⁰, Bhavna Lall¹¹, Heidi Larson¹², Timothy Sheahan¹³, Shmuel Shoham¹⁴, Annelies Wilder-Smith^{12

15}, Samba O Sow^{16

17}, Nathalie Strub-Wourgaft^{15

18}, Prashant Yadav^{19

20

21}, Carolina Batista²²

Affiliations

¹ ISGlobal-Barcelona Institute for Global Health-Hospital Clinic-University of Barcelona, Spain.
² Texas Children's Center for Vaccine Development, Baylor College of Medicine, Houston, TX, USA.
³ Koç University Research Center for Infectious Diseases, Istanbul, Turkey.
⁴ University of the West Indies at Mona, Kingston, Jamaica.
⁵ Nuffield Department of Medicine, Oxford University, Jenner Institute, Oxford, UK.
⁶ Middle East Technical University, Ankara, Turkey.
⁷ College of Medicine, King Saud University, Riyadh, Saudi Arabia.
⁸ Christian Medical College, Vellore, India.
⁹ Program for Appropriate Technology in Health (PATH) Essential Medicines, PATH, Seattle, WA, USA.
¹⁰ International Vaccine Institute, Seoul, South Korea.
¹¹ University of Houston College of Medicine, Houston, TX, USA.
¹² London School of Hygiene & Tropical Medicine, London, UK.
¹³ University of North Carolina, Gillings School of Global Public Health, Chapel Hill, NC, USA.
¹⁴ Johns Hopkins University School of Medicine, Baltimore, MD, USA.
¹⁵ Heidelberg Institute of Global Health, University of Heidelberg, Heidelberg, Germany.
¹⁶ Center for Vaccine Development, Bamako, Mali.
¹⁷ University of Maryland, MD, USA.
¹⁸ Drugs for Neglected Diseases Initiative, Geneva, Switzerland.
¹⁹ Center for Global Development, Washington, DC, USA.
²⁰ Harvard Medical School, Boston, MA, USA.
²¹ Technology and Operations Management, INSEAD, France.
²² Médecins Sans Frontières, Rio de Janeiro, Brazil.

PMID: 34099998
PMCID: PMC8173024
DOI: 10.1016/j.eclinm.2021.100925

Beyond the jab: A need for global coordination of pharmacovigilance for COVID-19 vaccine deployment

Denise Naniche et al. EClinicalMedicine. 2021 Jun.

. 2021 Jun:36:100925.

doi: 10.1016/j.eclinm.2021.100925. Epub 2021 Jun 3.

Authors

Affiliations

¹ ISGlobal-Barcelona Institute for Global Health-Hospital Clinic-University of Barcelona, Spain.
² Texas Children's Center for Vaccine Development, Baylor College of Medicine, Houston, TX, USA.
³ Koç University Research Center for Infectious Diseases, Istanbul, Turkey.
⁴ University of the West Indies at Mona, Kingston, Jamaica.
⁵ Nuffield Department of Medicine, Oxford University, Jenner Institute, Oxford, UK.
⁶ Middle East Technical University, Ankara, Turkey.
⁷ College of Medicine, King Saud University, Riyadh, Saudi Arabia.
⁸ Christian Medical College, Vellore, India.
⁹ Program for Appropriate Technology in Health (PATH) Essential Medicines, PATH, Seattle, WA, USA.
¹⁰ International Vaccine Institute, Seoul, South Korea.
¹¹ University of Houston College of Medicine, Houston, TX, USA.
¹² London School of Hygiene & Tropical Medicine, London, UK.
¹³ University of North Carolina, Gillings School of Global Public Health, Chapel Hill, NC, USA.
¹⁴ Johns Hopkins University School of Medicine, Baltimore, MD, USA.
¹⁵ Heidelberg Institute of Global Health, University of Heidelberg, Heidelberg, Germany.
¹⁶ Center for Vaccine Development, Bamako, Mali.
¹⁷ University of Maryland, MD, USA.
¹⁸ Drugs for Neglected Diseases Initiative, Geneva, Switzerland.
¹⁹ Center for Global Development, Washington, DC, USA.
²⁰ Harvard Medical School, Boston, MA, USA.
²¹ Technology and Operations Management, INSEAD, France.
²² Médecins Sans Frontières, Rio de Janeiro, Brazil.

PMID: 34099998
PMCID: PMC8173024
DOI: 10.1016/j.eclinm.2021.100925

No abstract available

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Conflict of interest statement

MEB and PH are developers of a COVID-19 vaccine construct, which was licensed by Baylor College of Medicine to Biological E Ltd., a commercial vaccine manufacturer for scale up, production, testing and licensure. MG participates in one of eight SARS-CoV-2 vaccine development projects supported by The Scientific and Technological Research Council of Turkey (TÜBİTAK) since March 2020. SG is cofounder of Vaccitech and has a patent on ChAdOx1 nCoV-19 licensed to AstraZeneca. MH is Founder and Managing Director of SaudiVax. JPF and GK are members of the WHO SAGE Working Group on COVID-19 vaccines. GK is independent director of Hilleman Laboratories Private Limited and Vice Chair of the Board, Coalition of Epidemic Preparedness Innovations (CEPI). DK reports grants from Bill and Melinda Gates Foundation (BMGF) and grants from CEPI. JK reports personal fees from SK biosciences. HL reports grants and honoraria from GlaxoSmithKline for training talks and from Merck as a member of the Merck Vaccine Confidence Advisory Board, outside the submitted work. TS reports grants from National Institute of Allergy and Infectious Disease and Fast Grants and research contracts from GlaxoSmithKline, and ViiV Healthcare. SS reports grants from Ansun BioPharma, Astellas Pharma, Cidara Therapeutics, F2G, Merck, T2 Biosystems, Shire Pharmaceuticals, Shionogi, and Gilead Sciences, outside the submitted work; and personal fees from Amplyx Pharmaceuticals, Acidophil, Janssen Pharmaceuticals, Reviral, Intermountain Healthcare, Karyopharm Therapeutics, Immunome, and Celltrion, outside the submitted work. All other authors declare no conflict of interests. The authors views and opinions in the Commentary do not necessarily represent the views, decisions, or policies of the institutions, universities, or health systems with which they are affiliated.

References

1. McGill COVID19 Vaccine Tracker Team – COVID19 vaccine tracker . [cited 2021 Mar 8]. Available from: https://covid19.trackvaccines.org/vaccines/
1. J. Holder. Tracking coronavirus vaccinations around the world . [cited April 23, 2021 ] Available from: https://www.nytimes.com/interactive/2021/world/covid-vaccinations-tracke...
1. Acharya K.P., Ghimire T.R., Subramanya S.H. Access to and equitable distribution of COVID-19 vaccine in low-income countries. NPJ Vaccines. 2021;6:54. doi: 10.1038/s41541-021-00323-6. - DOI - PMC - PubMed
1. Sultana J., Mazzaglia G., Luxi N., Cancellieri A., Capuano A., Ferrajolo C. Vol. 19. Taylor and Francis Ltd.; 2020. Potential effects of vaccinations on the prevention of COVID-19: rationale, clinical evidence, risks, and public health considerations; pp. 919–936. (Expert review of vaccines). - PubMed
1. Report of the 7th global vaccine safety initiative (GVSI) meeting . [cited 2021 Mar 24]. Available from: https://www.who.int/publications/i/item/WHO-MVP-EMP-SAV-2019.01

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Beyond the jab: A need for global coordination of pharmacovigilance for COVID-19 vaccine deployment

Affiliations

Beyond the jab: A need for global coordination of pharmacovigilance for COVID-19 vaccine deployment

Authors

Affiliations

Conflict of interest statement

References

LinkOut - more resources

Full Text Sources