Shoaibi, Azza http://orcid.org/0000-0002-6976-2594
Rao, Gowtham A.
Voss, Erica A.
Ostropolets, Anna
Mayer, Miguel Angel
Ramírez-Anguita, Juan Manuel
Maljković, Filip
Carević, Biljana
Horban, Scott
Morales, Daniel R.
Duarte-Salles, Talita
Fraboulet, Clement
Le Carrour, Tanguy
Denaxas, Spiros
Papez, Vaclav
John, Luis H.
Rijneek, Peter R.
Minty, Evan
Alshammari, Thamir M.
Makadia, Rupa
Blacketer, Clair
DeFalco, Frank
Sena, Anthony G.
Suchard, Marc A.
Prieto-Alhambra, Daniel
Ryan, Patrick B.
Funding for this research was provided by:
Innovative Medicines Initiative (806968)
Article History
Accepted: 1 May 2022
First Online: 2 June 2022
Declarations
:
: AS, GR, EAV, RM, AGS, CB, FD, and PBR are employees of Janssen Biotech Inc., a Janssen Pharmaceutical Company of Johnson & Johnson and shareholder of Johnson & Johnson, the product manufacturer of Janssen COVID-19 Vaccine. PRR is an employee of an institution that receives/received research grants from Janssen Research and Development LLC. DPA’s research group has received research grants from the European Medicines Agency, from the Innovative Medicines Initiative, and from Amgen, Chiesi, and UCB Biopharma; and consultancy or speaker fees from Astellas, Amgen, and UCB Biopharma. AO has received funding from the US National Institutes of Health and the US Food and Drug Administration. MAS receives grants and contracts from the US Food and Drug Administration and the US Department of Veterans Affairs within the scope of this research, and grants and contracts from the US National Institutes of Health, IQVIA, and Private Health Management outside the scope of this research. MAM, JMRA, FM, BC, SH, DRM, TDS, CF, TC, SD, VP, LHJ, EM, and TMA have no conflicts of interest to declare that are directly relevant to the contents of this study.
: This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 806968. The JU receives support from the European Union’s Horizon 2020 research and innovation program and EFPIA. Funders had no role in the conceptualization, design, data collection, analysis, decision to publish, or preparation of the manuscript.
: The JMDC data for these analyses were made available to the authors by JMDC, Inc. The use of SIDIAP was approved by the Clinical Research Ethics Committee of the IDIAPJGol (project code: 21/200-PCV). The use of IMASIS was approved by the Parc de Salut Mar Research Ethics Committee (CEIC Parc de Salut Mar, ref. code 2021/9975). “Association between thrombosis with thrombocytopenia syndrome or thromboembolic events, and COVID-19 vaccines" has been approved by the IPCI Review Board (October 14, 2021; project 7/2021).
: Not applicable.
: Not applicable.
: The data that support the findings are available at the sources of the 17 participating data owners separately. Some of the data sources are available for licensing from IBM, Optum, and CPRD. Data are available from IBM at ExternalRef removed, from Optum at ExternalRef removed, and from CPRD at ExternalRef removed.
: All analytic code used for the analysis is open source and has been made publicly available at ExternalRef removed and ExternalRef removed<u>.</u>
: All coauthors contributed to the conceptualization of this work. AS and GAR performed the data analysis. AS drafted the first draft of the manuscript. All co-authors revised, edited, and approved the manuscript. All authors read and approved the final version.