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Article History

Received: 30 September 2020

Accepted: 11 February 2021

First Online: 11 March 2021

Ethics approval and consent to participate

: Approval was received from the Independent Scientific Advisory Committee of the Medicines and Healthcare Products Regulatory Agency (ISAC number: 20_062A) and the Ethics Committee of the London School of Hygiene and Tropical Medicine (reference 21851). The ISAC protocol was made available to reviewers.

: Not applicable.

: JLW, DJG, NA, JAS, LS, MR, HM received grants from the NIHR HPRU in Immunisation to support the submitted work. RME received grants from HDR UK (MR/S003975/1) and UK MRC (MC_PC 19065). JKQ reports grants and personal fees from AZ, grants from Asthma UK, grants and personal fees from BI, grants and personal fees from Bayer, grants and personal fees from Insmed, grants and personal fees from GSK, grants from The Health Foundation, grants from MRC, grants from British Lung Foundation, outside the submitted work; RM reports personal fees from AMGEN, outside the submitted work; JAS reports grants from National Institute for Health Research, during the conduct of the study; grants from MRC, grants from Wellcome Trust, grants from GAVI The Vaccine Alliance, grants from Bill & Melinda Gates Foundation, outside the submitted work; LS reports grants from Wellcome, grants from MRC, grants from NIHR, grants from GSK, grants from BHF, grants from Diabetes UK, outside the submitted work; and Is a Trustee of the British Heart Foundation. The PHE Immunisation and Countermeasures Department provides vaccine manufacturers with post-marketing surveillance reports which the companies are required to submit to the UK Licensing authority in compliance with their Risk Management Strategy. A cost recovery charge is made for these reports.