First Covid vaccine study for pregnant women launches in the UK

The first coronavirus vaccine study for women who are pregnant has been launched across a number of sites in the UK.

The study will look to understand the safety, tolerability and immunogenicity of the Pfizer-BioNTech Covid-19 jab in women who are both pregnant and healthy.

Recruitment for the approximately 235 UK participants will begin this week, with the study taking place across eleven sites. These will include locations in Newcastle, Leeds, London, Oxford, Gillingham, Edinburgh and Southampton.

Participants will initially receive two doses of the vaccine of 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.

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.

Dr Chrissie Jones, Chief Investigator for the study explained: “While we have a large amount of real-world data which tells us that it’s safe for pregnant women to receive approved Covid-19 vaccines, the data gathered from a controlled research study like this is important because it will give us more information about the vaccine immune response in pregnant women.”

Following guidance released in April from the Joint Committee on Vaccination and Immunisation (JCVI), pregnant women are now being offered approved Covid 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 United States, data has been collected on over 100,000 pregnant women who have been vaccinated and no safety concerns were raised. This began in February 2021.

Candidates for the study will be identified via obstetricians and midwives at the hospital sites. The study doctor will then decide whether or not each pregnant woman and their unborn baby could be suitable to take part.

Participation in the study is voluntary and participants will be able to leave the study at any time.

Professor Andrew Ustianowski, National Clinical Lead for the UK NIHR Covid Vaccine Research Programme, said he hoped that the “extra monitoring involved being a participant” will help to “attract potential volunteers to this important study.”

“We want to ensure we provide the data to guide the best way of protecting and vaccinating our entire population. This includes pregnant women and I am excited that this study is commencing as there are important questions still to be answered,” he added.

Study volunteers will be recruited across 11 sites. These will include: