Padua, 30 June 2022 – A large study on the effectiveness of the Pfizer Covid-19 vaccine in children aged 5-11 was published in The New England Journal of Medicine.
The study was conducted at Israel’s largest healthcare organization, Clalit Health Services, in collaboration with researchers from the University of Padua, Harvard University and University College London.
This is one of the first large observational studies that uses Real-World Data evaluate the effectiveness of the Pfizer-BioNTech BNT162b2 (Comirnaty) vaccine in children aged 5-11 against the Omicron variant. The study compared rates of Covid-19-related outcomes in 94,728 vaccinated children, with 94,728 rigorously matched unvaccinated controls.
Estimated short-term vaccine effectiveness was moderate: 51% against documented SARS-CoV-2 infection and 48% against symptomatic Covid-19 illness, during days 7-21 following the second dose. A trend towards higher effectiveness was observed among the youngest age group (5-6 year-old children) compared to the oldest age group (10-11 year-old children) within the study population. Researchers are yet to determine which part of this reduced protective effect may be attributed to the different dose formulation, and which part may be attributed to the vaccine’s ability to mount an effective response against the Omicron strain.
Previous studies revealed that the short-term effectiveness of this vaccine in preventing symptomatic Covid-19 was very high in adolescents against the Delta strain. However, there was not enough information available on vaccine effectiveness in younger children.
Researchers studied the effects of the paediatric formulation of Pfizer-BioNTech’s Covid-19 vaccine over the period of 23 November 2021 through 7 January 2022, as the Omicron (B.1.1.529) variant of SARS-CoV-2 became the dominant strain in Israel – one of the of the first countries to launch a campaign to vaccinate children 5-11 years of age.
This study represents an international collaboration of researchers from Israel, the United States and Europe, as part of the Ivan and Francesca Berkowitz Family Living Laboratory Collaboration and the VERDI Project, which is coordinated by the University of Padua, the Penta Foundation, and funded by the European Union Horizon Europe Programme.
This is the first peer-reviewed cohort study to control for differences between the two study groups across many characteristics, including demographic factors, number of chronic medical conditions and health seeking behavior.
Findings from this study have been discussed by researchers coming from more than 30 healthcare and policy institutions worldwide, including from Israel, Haiti, South Africa, Thailand and the United States, at the VERDI General Assembly held in Padua, Italy, from 28 to 30 June 2022.
Carlo Giaquinto, Professor of Paediatrics at the Department for Woman’s and Child’s Health of the University of Padua and President of the Penta Foundation, as well as VERDI Project Coordinator, said: “This study from the Clalit data warehouse shows how Real-World Data can be used to quickly provide estimation on the effectiveness of new interventions, such as the paediatric formulation of Pfizer-BioNTech’s Covid-19 vaccine. These results present early evidence, where evidence has been limited, on how Covid-19 vaccination is also effective in the paediatric population.”
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Notes for Editors
About the article
Title: BNT162b2 Vaccine Effectiveness against Omicron in Children 5 to 11 Years of Age
Authors: Chandra J. Cohen-Stavi, Ph.D., Ori Magen, M.D., Noam Barda, M.D., Ph.D., Shlomit Yaron, M.D., Alon Peretz, M.D., Doron Netzer, M.D., Carlo Giaquinto, M.D., Ali Judd, Ph.D., Leonard Leibovici, M.D., Miguel A. Hernán, M.D., Marc Lipsitch, D.Phil., Ben Y. Reis, Ph.D., et al.
Published in in: The New England Journal of Medicine, 29 June 2022
DOI: 10.1056/NEJMoa2205011
https://www.nejm.org/doi/full/10.1056/NEJMoa2205011
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About VERDI
The VERDI project (SARS-coV2 variants Evaluation in pRegnancy and paeDIatrics cohorts, project ID 101045989) is funded by the European Union. Views and opinions expressed are however those of the VERDI Consortium only and do not necessarily reflect those of the European Union or the European Health and Digital Executive Agency. Neither the European Union nor the granting authority can be held responsible for them.
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About Penta
Penta is an international independent scientific network dedicated to child health.
Through our studies, training programmes and collaborations in the area of paediatric infectious disease, we want to improve the lives of women and children, wherever they live.
Penta was born in 1991 with the aim of undertaking independent clinical trials on antiretroviral therapies for children with HIV. To-date, the Penta portfolio of studies includes other paediatric infectious diseases, such as hepatitis, tuberculosis, fungal diseases, sepsis as well as infections in pregnancy and emerging or neglected childhood infections. Our work is the result of collaborations between medical professionals and researchers in more than 110 centres in 31 countries around the world.
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Read Clalit’s Press Release here.