1. Adverse Events Following Immunization With mRNA and Viral Vector Vaccines in Individuals With Previous Severe Acute Respiratory Syndrome Coronavirus 2 Infection From the Canadian National Vaccine Safety Network.
- Author
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Bettinger JA, Irvine MA, Shulha HP, Valiquette L, Muller MP, Vanderkooi OG, Kellner JD, Top KA, Sadarangani M, McGeer A, Isenor JE, Marty K, Soe P, and De Serres G
- Subjects
- Adult, Humans, 2019-nCoV Vaccine mRNA-1273, BNT162 Vaccine, Canada epidemiology, Cohort Studies, Immunization, Prospective Studies, RNA, Messenger, SARS-CoV-2, Vaccination adverse effects, COVID-19 prevention & control, COVID-19 Vaccines adverse effects, Viral Vaccines
- Abstract
Background: Adults previously infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) develop short-term immunity and may have increased reactogenicity to coronavirus disease 2019 (COVID-19) vaccines. This prospective, multicenter, active-surveillance cohort study examined the short-term safety of COVID-19 vaccines in adults with a prior history of SARS-CoV-2., Methods: Canadian adults vaccinated between 22 December 2020 and 27 November 2021 were sent an electronic questionnaire 7 days post-dose 1, dose 2, and dose 3 vaccination. The main outcome was health events occurring in the first 7 days after each vaccination that prevented daily activities, resulted in work absenteeism, or required a medical consultation, including hospitalization., Results: Among 684 998 vaccinated individuals, 2.6% (18 127/684 998) reported a prior history of SARS-CoV-2 infection a median of 4 (interquartile range: 2-6) months previously. After dose 1, individuals with moderate (bedridden) to severe (hospitalized) COVID-19 who received BNT162b2, mRNA-1273, or ChAdox1-S vaccines had higher odds of a health event preventing daily activities, resulting in work absenteeism or requiring medical consultation (adjusted odds ratio [95% confidence interval]: 3.96 [3.67-4.28] for BNT162b2, 5.01 [4.57-5.50] for mRNA-1273, and 1.84 [1.54-2.20] for ChAdox1-S compared with no infection). Following dose 2 and 3, the greater risk associated with previous infection was also present but was attenuated compared with dose 1. For all doses, the association was lower or absent after mild or asymptomatic infection., Conclusions: Adults with moderate or severe previous SARS-CoV-2 infection were more likely to have a health event sufficient to impact routine activities or require medical assessment in the week following each vaccine dose., Competing Interests: Potential conflicts of interest. M. S. has been an investigator on projects funded by GlaxoSmithKline, Merck, Moderna, Pfizer, Sanofi-Pasteur, Seqirus, Symvivo, and VBI Vaccines, outside the submitted work. All funds have been paid to his institution, and he has not received any personal payments; he is also the Chair/Deputy Chair of 2 Data Safety and Monitoring Boards (DSMBs) for coronavirus disease 2019 (COVID-19) vaccine trials, involving different vaccines. O. G. V. has been an investigator, coinvestigator, and/or expert panelist on projects funded by GlaxoSmithKline, Merck, Pfizer, and Seqirus, outside the submitted work, and reports grants or contracts from Pfizer Canada and a Pneumococcal Grant in AID (paid to their institution) and consulting fees from Merck, Pfizer, Seqirus, AstraZeneca, and Sanofi-Pasteur. J. D. K. has been an investigator on projects funded by GlaxoSmithKline, Merck, Moderna, and Pfizer, outside the submitted work, and reports grants or contracts as Site Investigator for a phase 2/3, 2-part, open-label, dose-escalation, age de-escalation and randomized, observer-blind, placebo-controlled expansion study to evaluate the safety, tolerability, reactogenicity, and effectiveness of mRNA-1273 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine in healthy children 6 months to less than 12 years of age (mRNA-1273-P204 Study; ClinicalTrials.gov Identifier: NCT04796896); a DSMB, VIDO (University of Saskatchewan Vaccine and Infectious Disease Organization)–sponsored COVID-19 vaccine clinical trial, “A Randomized, Observer-Blind, Dose-Escalation, Phase 1/2 Clinical Trial of COVAC Vaccines in Healthy Adults” (unpaid volunteer position); a leadership or fiduciary role in other board, society, committee, or advocacy group; the Canadian COVID-19 Immunity Task Force: Member, Leadership Group; Co-chair, Field Studies Working Party; and Lead, Pediatric Network (unpaid volunteer position). All funds have been paid to his institution, and he has not received any personal payments. K. A. T. has been an investigator on projects funded by GlaxoSmithKline, outside the submitted work, and reports grants or contracts from Canadian Institutes of Health Research, Public Health Agency of Canada (payment to their institution for vaccine safety evaluation studies), and Coalition for Epidemic Preparedness Innovations (payment to their institution for a vaccine safety study); payment or honoraria for lectures, presentations, speaker’s bureaus, manuscript writing, or educational events for the Canadian Society of Allergy and Clinical Immunology (speaker’s fees on COVID-19 vaccines) and Family Practice Renewal Program (Newfoundland) (speaker’s fees for COVID-19 vaccines); consulting fees for the World Health Organization (payments to author for leading vaccines safety training in middle-income countries); support for attending meetings and/or travel from Canadian Public Health Association (support to attend in person and virtual Canadian Immunization Conference). All funds have been paid to her institution, and she has not received any personal payments. J. E. I. has been an investigator on projects funded by the Canadian Institutes of Health Research, Drug Evaluation Alliance of Nova Scotia, Dalhousie Pharmacy Endowment Fund, Shoppers Drug Mart, GlaxoSmithKline, Sanofi-Pasteur, Canadian Frailty Network, and Nova Scotia Health Research fund. All funds have been paid to her institution, and she has not received any personal payments. A. M. has been an investigator on projects funded by GlaxoSmithKline, Merck, Pfizer, Sanofi-Pasteur, and Seqirus, with funds paid to her institution, and has received honoraria for participation in advisory boards from AstraZeneca, GlaxoSmithKline, Medicago, Merck, Moderna, Pfizer, Sanofi-Pasteur, and Seqirus, and for presentations from AstraZeneca, and Moderna, including participation on a DSMB or advisory board for Pfizer, GlaxoSmithKline, Moderna, Medicago, Janssen, and AstraZeneca. G. D. S. and L. V. have been investigators on a project funded by Pfizer, outside the submitted work. All funds have been paid to their institution, and they have not received any personal payments. L. V. also reports being a co-founder and stockholder for Lumed, a company developing and commercializing expert systems in the fields of antimicrobial stewardship, infection control, and oncology. J. A. B. reports participation on an Advisory Committee for the National Advisory Committee on Immunization as a member (volunteer, unpaid participation). All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed., (© The Author(s) 2022. Published by Oxford University Press on behalf of Infectious Diseases Society of America.)
- Published
- 2023
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