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"Keep, Georgina"
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Serum Troponin I Assessments in 5- to 30-Year-Olds After BNT162b2 Vaccination
2024
IntroductionRare myocarditis and pericarditis cases have occurred in coronavirus disease 2019 (COVID-19) messenger RNA (mRNA) vaccine recipients. Troponin levels, a potential marker of myocardial injury, were assessed in healthy participants before and after BNT162b2 vaccination.MethodsVaccine-experienced 12- to 30-year-olds in phase 3 crossover C4591031 Substudy B (NCT04955626) who had two or three prior BNT162b2 30-μg doses were randomized to receive BNT162b2 30 μg followed by placebo, or placebo followed by BNT162b2 30 µg, 1 month apart. A participant subset, previously unvaccinated against COVID-19, in the phase 3 C4591007 study (NCT04816643) received up to three vaccinations (BNT162b2 10 μg or placebo [5- to 11-year-olds]) or open-label BNT162b2 30 μg (12- to 15-year-olds). Blood samples collected pre-vaccination, 4 days post-vaccination, and 1-month post-vaccination (C4591031 Substudy B only) were analyzed. Frequencies of elevated troponin I levels (male, > 35 ng/l; female, > 17 ng/l) were assessed.ResultsPercentages of 12- to 30-year-olds (n = 1485) in C4591031 Substudy B with elevated troponin levels following BNT162b2 or placebo receipt were 0.5% and 0.8% before vaccination, 0.7% and 1.0% at day 4, and 0.7% and 0.5% at 1 month, respectively. In Study C4591007 (n = 1265), elevated troponin I levels were observed in 0.2, 0.4, and 0.2% of 5- to 11-year-old BNT162b2 recipients at baseline and 4 days post-dose 2 and 3, respectively; corresponding values in 12- to 15-year-olds were 0.4, 0.4, and 0.7%. No 5- to 11-year-old placebo recipients had elevated troponin levels. No myocarditis or pericarditis cases or deaths were reported.ConclusionsAmong 5- to < 30-year-olds in both studies, troponin levels were rarely elevated (≤ 1.0%) and similar before and post-vaccination; troponin levels were also similar between BNT162b2 and placebo in 12- to 30-year-old and 5- to 11-year-old recipients in the respective studies. No myocarditis or pericarditis cases were reported. These findings did not provide evidence that BNT162b2 causes troponin elevations. No utility of routine measurement of troponin levels in asymptomatic BNT162b2 recipients was identified.
Journal Article
Safety and Efficacy of a Third Dose of BNT162b2 Covid-19 Vaccine
by
Nell, Haylene
,
Lu, Claire
,
Berhe, Mezgebe
in
BNT162 Vaccine
,
Clinical trials
,
Confidence intervals
2022
In an extension of the pivotal randomized trial showing vaccine efficacy, approximately 10,000 adults who had received two doses of BNT162b2 were assigned to receive a third dose or placebo. Local reactions were common but mild and transient. During a median follow-up of 2.5 months, SARS-CoV-2 was identified in 6 participants in the vaccine group and in 123 in the placebo group, for a vaccine efficacy of 95.3%.
Journal Article
Champion who took the plunge for women THE EXTRAORDINARY OLYMPIC SAGA OF SWIMMER MINA WYLIE
2012
A builder by trade, and an underwater swimming champion himself, Wylie constructed the sea walls for the baths and built an elaborate, elevated timber viewing deck.
Newspaper Article
Better Health in Harder Times
2012,2013
For years the NHS has been the most trusted of public institutions and the envy of many around the world. But today there is turmoil. Painful shortcomings in clinical care and patient experience, together with funding cuts, threaten to dig deep into service levels and standards. Seventy years of technically advanced medicine provided free to the population has produced a widespread perception of patients as passive consumers of health care.
This book explores how we may renew for our times the collective compact that created our public services in the 1940s. Voices from service users and service providers show how this can be done. They offer testimony of what goes wrong and what can be put right when working together becomes the norm. Sections explore new ways of living and working with long-term conditions, more meaningful and effective approaches to service redesign, use of information technology, leadership, co-production and creating and accounting for quality. Accessible to a wide range of readers, with short, accessible contributions, this is a book to provoke and inspire.