mRNA vacciners in pregnancy

18 days ago
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Pregnancy

A Study of mRNA-1283 Injection Compared With mRNA-1273 Injection in Participants ≥12 Years of Age to Prevent COVID-19

https://ctv.veeva.com/study/a-study-of-mrna-1283222-injection-compared-with-mrna-1273222-injection-in-participants-12-years-o

Key Inclusion Criteria:

For female participants of childbearing potential:

negative pregnancy test,

adequate contraception or has abstained from all activities that could result in pregnancy

for at least 28 days prior to the first injection,

and agreement to continue adequate contraception

or abstinence through 90 days following the vaccine administration.

In other words

Pregnant or potentially pregnant women are excluded
Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine

https://www.nejm.org/doi/full/10.1056/NEJMoa2034577

This report does not address the prevention of Covid-19 in other populations, such as younger adolescents, children, and pregnant women.
https://www.nhs.uk/pregnancy/keeping-well/pregnancy-and-covid-19/

It's strongly recommended that you get vaccinated against COVID-19 to protect you and your baby.
https://www.rcog.org.uk/guidance/coronavirus-covid-19-pregnancy-and-women-s-health/vaccination/covid-19-vaccines-pregnancy-and-breastfeeding-faqs/

(updated on 20 October 2023)

COVID-19 vaccines are strongly recommended in pregnancy. Vaccination is the best way to protect against the known risks of COVID-19 in pregnancy for both women and babies

https://vaccineknowledge.ox.ac.uk/covid19-vaccines-in-pregnancy#Are-COVID-19-vaccines-recommended-for-pregnant-people

COVID-19 vaccines are recommended during pregnancy due to an increased risk of serious illness and complications from COVID-19 in pregnant people,
https://www.rcog.org.uk/media/0qune0d3/covid-19-infection-in-pregnancy-v161-final.pdf

Vaccination in pregnancy against COVID-19 is strongly recommended

2025
https://www.gov.uk/government/publications/covid-19-vaccination-in-2025-and-spring-2026-jcvi-advice/jcvi-statement-on-covid-19-vaccination-in-2025-and-spring-2026

Pregnancy, neonates and young infants

Recent data indicates that the risk of hospitalisation and/or mortality in pregnant individuals has significantly reduced in the Omicron period.

Notably, there were no deaths in people who were pregnant in the last 18 months

…. JCVI advised that it was highly unlikely that vaccination in pregnancy would be cost-effective.

Exclusion of pregnant and lactating women from COVID-19 vaccine trials: a missed opportunity

https://pmc.ncbi.nlm.nih.gov/articles/PMC7989536/?utm_source=chatgpt.com

The exclusion of pregnant and lactating women from COVID-19 vaccine trials reflects a historic pattern of ‘protection by exclusion’,

representing an instance in which the estimated effect of a therapy on mother and child will rely on anecdotal and delayed reports from healthcare settings

rather than the monitored setting of a clinical trial.

This exclusion is not justified.

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