Covid-19 vaccine study for pregnant women launches
The first Covid-19 vaccine study for women who are pregnant has been launched across the UK – with Edinburgh playing a key role in the research.
The study will look to understand the safety and tolerability of the Pfizer-BioNTech jab in women who are both pregnant and healthy.
It will also seek to evaluate the immunogenicity of the jab in pregnant women – the type of immune responses that the vaccine generates and their magnitude over time.
Recruitment for more than 200 UK participants will begin this week. The study, which involves the University of Edinburgh’s MRC Centre for Reproductive Health, is taking place across 11 sites, including the Royal Infirmary of Edinburgh.
Participants will initially receive two doses of the Pfizer-BioNTech vaccine or a placebo with a gap of 21 days between them. The placebo will consist of a salt water solution which does not contain any active ingredients. Women who receive placebo will be given the first dose of Pfizer-BioNTech vaccine one month after birth and the second dose 21 days later.
Those who take part will then be required to answer questionnaires about their health. They will also be asked to provide blood samples, complete an e-diary and will receive extra monitoring throughout the study.
As well as this, volunteers will need to visit their site four times before their baby is born, and twice after the birth.
The role of the study is to provide more information on the immune response in those who are pregnant, as well as looking at whether or not maternal antibodies are transferred to infants.
Following guidance released in April from the Joint Committee on Vaccination and Immunisation, pregnant women are now being offered approved Covid-19 vaccines at the same time as the rest of the UK population. The timing of their vaccination is based on their age and clinical risk group.
In the US, data has been collected on more than 100,000 pregnant women who have been vaccinated and no safety concerns were raised. This began in February 2021.
Potential study participants be referred to the study team by their midwife or doctor. The study team will make sure that the pregnant woman would be suitable to take part.
Participation in the research is voluntary and participants will be able to leave the study at any time. The study is fully funded by Pfizer.
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.”