Implementation and results of active vaccine safety monitoring during the COVID-19 pandemic in the UK DOI Creative Commons
Jenny Wong, Katherine Donegan,

Kendal Harrison

et al.

Published: Nov. 12, 2024

Abstract Introduction Yellow Card Vaccine Monitor (YCVM) was established by the UK Medicines and Healthcare products Regulatory Agency (MHRA) to facilitate active monitoring of adverse reactions following COVID-19 vaccination further characterise safety in populations under-represented clinical trials. Methods Randomly selected individuals were invited register actively contacted seek information on vaccines received events they experienced. Demographics patients recruited, summaries reported data, are presented alongside detailed analyses sub-cohort pregnant breast-feeding conducted support regulatory assessment two signals, menstrual disorders, tinnitus. Results 36,604 registered, with 30,281 reporting vaccination. Median [IQR] follow-up 184 days [14-367]. recruited cohort reflected vaccinated population timing invitations. 15,764 (52.1%) those vaccination, experiencing at least one reaction. However, nearly all expected acute only 4,134 (13.7%) an event considered medically serious. The data raised no concerns patients. Reporting disorders appeared stimulated media interest, as seen spontaneous systems. Data incidence tinnitus used action this signal. Discussion Active surveillance provided a complimentary source for COVID- 19 vaccines. efforts needed recruit ethnic minorities. technology developed has enhanced vigilance options could be valuable future innovative small populations.

Language: Английский

COVID-19 vaccination and birth outcomes of 186,990 women vaccinated before pregnancy: an England-wide cohort study DOI Creative Commons
Arun S Karthikeyan, Rachel Denholm,

Matthew Retford

et al.

The Lancet Regional Health - Europe, Journal Year: 2024, Volume and Issue: 45, P. 101025 - 101025

Published: Aug. 13, 2024

COVID-19 vaccination in pregnancy is recommended by the World Health Organisation as effective and safe. However, there remains a lack of robust evidence to inform choices for women childbearing potential relation their future pregnancies. Here we investigated association between starting course before birth outcomes. We analysed England-wide linked electronic health records all pregnancies reaching at least 24 weeks gestation 25th May 2021 28th October 2022. estimated incidence rates hazard ratios outcomes pre-pregnancy status. Based on 186,990 women, compared unvaccinated, receiving within 12 months was associated with lower risks very extremely preterm small-for-gestational age term babies any vaccine type (adjusted ratio 95% confidence interval: 0.74 [0.63, 0.88] 0.94 [0.88, 1.00], respectively), stillbirth risk those an mRNA (0.72 [0.52, 1.00]). Incidence venous thromboembolism during higher amongst viral-vector, but not (1.54 [1.10, 2.16] 1.02 [0.70, 1.50], respectively). Results were generally consistent different dose regimens across sensitivity analyses. found that from first vaccination, unvaccinated experienced fewer adverse outcomes, overall or selected subgroups general population, accounting confounders. An should be preferred viral-vector vaccine, minimise safety issues, where latter only choice, it still unvaccinated. The substantially attributable SARS-CoV-2 infection commonly used medications such hormone replacement therapy oral contraceptives non-pregnant population. UK National Institute Care Research (NIHR), UKRIMedical Council, Innovation, Alan Turing Institute, Data UK, Department Social Care.

Language: Английский

Citations

3
EVALUATING THE IMPACT OF COVID-19 ON THE PREGNANCY AND POSTNATAL PERIOD FOR UK WOMEN DOI Creative Commons
Gareth Nye,

George Abou Deb,

S Dunne

et al.

medRxiv (Cold Spring Harbor Laboratory), Journal Year: 2024, Volume and Issue: unknown

Published: April 30, 2024

ABSTRACT INTRODUCTION Pregnancy is a crucial period which ultimately directly impacts two individuals health and wellbeing. Within the UK, standardised pattern of care established with collaborations across disciplines to benefit women babies. During COVID19 pandemic, this was disrupted align protective protocols until now, has not been formally reported. METHODS A retrospective, mixed methods study UK based pregnant between years 2012 2022 inclusive no known complications conducted collate opinions experiences pregnancy without impact restrictions. Quantitative results were analysed using statistical package GraphPad Prism 9.2.0 presented as mean values +/- standard deviation appropriate. In addition, we used phased approach open ended questions. RESULTS Our showed significant difference in either number appointments or time first appointment however an increased percentage reported use private services during COVID pandemic. There change midwife postnatal but there reduction visitor appointments. Overall, pandemic led feeling less satisfied their both postnatally, they that continued be listened remained control pregnancy. DISCUSSION Generally, changes implemented did women’s journey substantially although have evidence long-term on child development. Clear themes can further improve maternity are key elements focus for future services.

Language: Английский

Citations

0
GBS vaccines in the UK: a round table discussion DOI Creative Commons
Natasha Thorn, Rebecca Guy, Konstantinos Karampatsas

et al.

F1000Research, Journal Year: 2024, Volume and Issue: 13, P. 519 - 519

Published: May 21, 2024

Background Group B streptococcus (GBS) remains a leading cause of infant sepsis, meningitis and death despite intrapartum antibiotic prophylaxis. A vaccine is urgently required, two candidates are in advanced clinical trials. For successful GBS implementation, especially if licensed based on an immunological threshold, there must be cross-sector engagement, effective advocacy, robust plans for phase IV studies equitable access. Meeting round-table discussion, held at St George’s University London, reviewed the current position vaccines UK context, focusing plans, convening diverse group stakeholders from across UK, with role licensure, implementation or effectiveness evaluation. Presentations outlined latest epidemiology, noting rising invasive (iGBS) infection rates 1996 to 2021 both early late onset disease, highest disease Black infants (1.1/1000 livebirths vs white (0.81/1000 livebirths). Potential coverage candidate was high (>95%). Regulatory input suggested that EU regulators would consider waiving need pre-licensure efficacy study putative correlate protection could adequately justified. Phase methodologies were considered, largely previous maternal assessments, such as nationwide cohort design using register services dataset. Other strategies also discussed cluster stepped-wedge randomised trial evaluate outcomes. Opportunities education engagement additional key partners identified. Conclusions With approved near possibility, planning identification critical barriers needed. Cross-sector essential will facilitate pathway.

Language: Английский

Citations

0
Implementation and results of active vaccine safety monitoring during the COVID-19 pandemic in the UK DOI Creative Commons
Jenny Wong, Katherine Donegan,

Kendal Harrison

et al.

Published: Nov. 12, 2024

Abstract Introduction Yellow Card Vaccine Monitor (YCVM) was established by the UK Medicines and Healthcare products Regulatory Agency (MHRA) to facilitate active monitoring of adverse reactions following COVID-19 vaccination further characterise safety in populations under-represented clinical trials. Methods Randomly selected individuals were invited register actively contacted seek information on vaccines received events they experienced. Demographics patients recruited, summaries reported data, are presented alongside detailed analyses sub-cohort pregnant breast-feeding conducted support regulatory assessment two signals, menstrual disorders, tinnitus. Results 36,604 registered, with 30,281 reporting vaccination. Median [IQR] follow-up 184 days [14-367]. recruited cohort reflected vaccinated population timing invitations. 15,764 (52.1%) those vaccination, experiencing at least one reaction. However, nearly all expected acute only 4,134 (13.7%) an event considered medically serious. The data raised no concerns patients. Reporting disorders appeared stimulated media interest, as seen spontaneous systems. Data incidence tinnitus used action this signal. Discussion Active surveillance provided a complimentary source for COVID- 19 vaccines. efforts needed recruit ethnic minorities. technology developed has enhanced vigilance options could be valuable future innovative small populations.

Language: Английский

Citations

0