Transparent coverage of clinical research

Importance Increased rates of myocarditis/pericarditis following COVID-19 mRNA vaccines have been observed. However, little data are available related to product-specific differences, which have important programmatic impacts. Objective The objective of this study was to estimate reporting rates of myocarditis/pericarditis following COVID-19 mRNA vaccine by product, age, sex, and dose number, as well inter-dose interval. Design We conducted a population-based cohort study using passive vaccine safety surveillance data. All individuals in Ontario, Canada who received at least one dose of COVID-19 mRNA vaccine between December 14, 2020 and September 4, 2021 were included. Setting This study was conducted in Ontario, Canada (population: 14.7 million) using the provincial COVID-19 vaccine registry and provincial adverse events following immunization database. Participants We included all individuals with a reported episode of myocarditis/pericarditis following COVID-19 vaccine in the study period. We obtained information on all doses administered in the province to calculate reporting rates. Exposure Receipt of COVID-19 mRNA vaccine (mRNA-1273 [Moderna Spikevax] or BNT162b2 [Pfizer-BioNTech Comirnaty]). Main Outcome(s) and Measure(s) Reported rate of myocarditis/pericarditis meeting level 1-3 of the Brighton Collaboration case definitions. Results There were 19,740,741 doses of mRNA vaccines administered and 297 reports of myocarditis/pericarditis meeting our inclusion criteria. Among these, 69.7% occurred following the second dose of COVID-19 mRNA vaccine and 76.8% occurred in males. The median age of individuals with a reported event was 24 years. The highest reporting rate of myocarditis/pericarditis was observed in males aged 18-24 years following mRNA-1273 as the second dose; the rate in this age group was 5.1 (95% CI 1.9-15.5) times higher than the rate following BNT162b2 as the second dose. Overall reporting rates were higher when the inter-dose interval was shorter (i.e., ≤30 days) for both vaccine products. Among individuals who received mRNA-1273 for the second dose, rates were higher for those who had a heterologous as opposed to homologous vaccine schedule. Conclusions and Relevance Our results suggest that vaccine product, inter-dose interval and vaccine schedule combinations may play a role in the risk of myocarditis/pericarditis, in addition to age and sex. Certain programmatic strategies could reduce the risk of myocarditis/pericarditis following mRNA vaccines. ### Competing Interest Statement The authors have declared no competing interest. ### Funding Statement This work was supported by Public Health Ontario. This work was also supported by the Canadian Immunization Research Network (CIRN) through a grant from the Public Health Agency of Canada and the Canadian Institutes of Health Research (CNF 151944). Additionally, this work was supported by ICES, which is funded by an annual grant from the Ontario Ministry of Health (MOH). JCK is supported by a Clinician-Scientist Award from the University of Toronto Department of Family and Community Medicine. The analyses, conclusions, opinions and statements expressed herein are solely those of the authors and do not reflect those of the funding or data sources; no endorsement is intended or should be inferred. ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The Public Health Ontario Ethics Review Board has determined that this project did not require research ethics committee approval as the activities described in this manuscript were conducted in fulfillment of Public Health Ontarios legislated mandate to provide scientific and technical advice and support to the health care system and the Government of Ontario in order to protect and promote the health of Ontarians (Ontario Agency for Health Protection and Promotion Act, SO 2007, c 10) and are therefore considered public health practice, not research. I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes Public Health Ontario (PHO) cannot disclose the underlying data. Doing so would compromise individual privacy contrary to PHOs ethical and legal obligations. Restricted access to the data may be available under conditions prescribed by the Ontario Personal Health Information Protection Act, 2004, the Ontario Freedom of Information and Protection of Privacy Act, the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2 (2018)), and PHO privacy and ethics policies. Data are available for researchers who meet PHOs criteria for access to confidential data. Information about PHOs data access request process is available on-line at .

Coming together to do the best thing for our children should involve an honest and apolitical look at the science, including both the risks to children from…

CECC says approval of COVID vaccines for children under 12 will not be considered until 2nd dose issue settled | 2021-11-10 15:42:00

The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that have yet to be certified by peer review.

Sweden and Denmark said on Wednesday they will pause the use of Moderna's COVID-19 vaccine for younger age groups after reports of possible rare side effects, such as myocarditis.

Objectives Establishing the rate of post-vaccination cardiac myocarditis in the 12-15 and 16-17-year-old population in the context of their COVID-19 hospitalization risk is critical for developing a vaccination recommendation framework that balances harms with benefits for this patient demographic. Design, Setting and Participants Using the Vaccine Adverse Event Reporting System (VAERS), this retrospective epidemiological assessment reviewed reports filed between January 1, 2021, and June 18, 2021, among adolescents ages 12-17 who received mRNA vaccination against COVID-19. Symptom search criteria included the words chest pain, myocarditis, pericarditis and myopericarditis to identify children with evidence of cardiac injury.....

The results provide some of the most detailed analysis yet of severe illness and death from the virus in children, a closely watched subject as schools prepare for a new academic year.

Almost 94 per cent of people in England had Covid antibodies overall which experts said was 'highly reassuring' and suggested most adults had Covid protection.