First vaccine study for pregnant women launches in Lothians
The first COVID-19 vaccine study recruiting pregnant women has been launched and is set to open in NHS Lothian.
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Around 235 women will be given the Pfizer-BioNTech COVID-19 vaccine or a placebo in the UK-wide study, which has been running in the US since February.
Following updated guidance from the Joint Committee on Vaccination and Immunisation (JCVI) released in April, pregnant women are now offered approved COVID-19 vaccines at the same time as the rest of the UK population.
It comes after data from the US revealed over 100,000 pregnant women have been vaccinated without any safety concerns raised, mainly with mRNA vaccines including Pfizer/BioNTech and Moderna.
There is no evidence to suggest other vaccines are unsafe for pregnant women but studies are ongoing.
Health chiefs said the Pfizer-funded study will provide more robust information on the vaccine immune response in pregnancy.
Each woman enrolled in the study will initially receive either two doses of the vaccine or a placebo 21 days apart.
Recruitment will start this week at Edinburgh’s Western General, along with ten other UK sites.
Women for the new study will be identified via obstetricians and midwives at the hospital sites involved.
Mums-to-be who take part will receive extra monitoring while on the study at four planned visits before their baby is born and then two more follow up appointments after the baby is born.
Dr Sarah Stock, Consultant Obstetrician and Subspecialist in Maternal and Fetal Medicine at the Royal Infirmary of Edinburgh, said:
“Catching COVID-19 in pregnancy can have serious consequences for mothers and their babies. This is an important study as it will not only help us understand how best to protect the mothers and babies of today, but also how we can prepare to protect those in the future.”
Professor Andrew Ustianowski, National Clinical Lead for the UK NIHR COVID Vaccine Research Programme, said: “We want to ensure we provide the data to guide the best way of protecting and vaccinating our entire population.
“The extra monitoring involved being a participant in this study, along with the possibility of some pregnant women receiving a licensed and effective COVID vaccine before they would through the national rollout, is something we hope will attract potential volunteers to this important study.”