Published: 25 November 2021
The Vaccine Institute at St George’s, University of London is leading on a Covid-19 vaccine study that will determine the most effective vaccines and gap between doses for pregnant women, and is looking to recruit more women to the trial.
Recent data show that 1 in 5 of the most critically ill Covid-19 patients are pregnant women who have not been vaccinated.
The current UK guidance is that Covid-19 vaccination should be offered to pregnant women at the same time as the rest of the population. Covid-19 vaccines are safe and effective for pregnant women, and there is a clinical consensus that it is the best way to protect both mother and baby from Covid.
The Preg-CoV study, led by researchers at St George’s, compares vaccines that are currently being used for the UK vaccination programme (Pfizer/BioNTech and Moderna) as well as new vaccines as they are approved. The NIHR-supported study will provide vital clinical trial data on the immune response to vaccination at different dose intervals - either four to six weeks or eight to 10 weeks. This data will help determine the best dosage interval and tell us more about how the vaccine works to protect pregnant mothers and their babies against Covid-19.
Data from UK Health Security Agency showed that over 84,600 pregnant women have received the first dose of the life-saving COVID-19 jab, and around 80,700 have received their second dose. However, further pregnancy-specific research is currently happening in the UK to provide more data around the most effective vaccines, and the best gap between vaccine doses for pregnant women.
Hundreds of women are needed in order to help provide further findings key to protecting more women and shaping future vaccine guidelines. The study launched in August 2021, and will involve 600 pregnant women, across 14 NIHR-supported sites across England. Volunteers will be closely monitored by health professionals throughout their pregnancy and following the birth.
Chief Investigator and Professor of Paediatric Infectious Diseases at St George's, University of London, Professor Paul Heath, said: “Over two hundred and fifty thousand pregnant women have now been vaccinated with Covid-19 vaccines in both the US and the UK, with no major safety concerns reported.
“Pregnant women should be very reassured about the safety of these vaccines. We do not yet know the best schedule to use to provide the maximal protection for pregnant women against Covid-19 and this is what we are addressing in this study.
“The Preg-CoV trial will inform national and international policy recommendations on the optimal use of Covid-19 vaccines in pregnancy.”
Pregnant women in the study will receive monitoring and additional support through study visits, compared to those who receive their vaccine outside of the study. They will also be provided a 24-hour phone line should they have any questions for the trial team and an electronic diary to record any symptoms. They will also be reimbursed for travel to their study appointments.
Once successfully enrolled, most participants will be randomised to receive two doses of an approved Covid-19 vaccine with either a short-time interval (4-6 weeks) or a long-time interval (8-10 weeks) between doses, with the majority of volunteers blinded to which vaccine they receive. For some participants this means they will receive their second dose after delivery. Participants will receive a single dose if they have already received their first dose or if they just need a booster (3rd) dose). All participants and their babies will be followed up until one year after delivery.
The study is seeking low-risk pregnant women, aged 18-45 years-old, carrying a single baby, and between 13-34 weeks' gestation. It is also recruiting participants who have already had two doses of a Covid-19 vaccine in the community.
Ruth Bowen, a Research Midwife working on the study at the Royal Cornwall Hospital, explained: “There’s a misunderstanding of receiving Covid-19 vaccines during pregnancy, which has probably put some pregnant women off getting vaccinated. It has been really hard seeing pregnant women receiving care in hospital due to Covid-19, especially because it could have been prevented by getting the Covid-19 vaccine. By joining the Preg-CoV study, pregnant women not only receive extra monitoring and support while getting their vaccines, but also help us to gather important data to better protect expecting mothers more effectively in the future.”
Debbie, a volunteer on the study, from Cornwall said: “I couldn’t wait for the study to start and felt more confident and comfortable about having the vaccine this way than heading to a local drop in centre. It gave me the confidence that I was going to be looked after during my vaccination journey. It provided everything I needed, which was health professionals such as a midwife, doctors and nurses who had the knowledge and experience around the vaccinations and the effects of Covid during pregnancy.
“I had so many questions and concerns as I joined the study which were all addressed by the study team. I even got to hear my baby's heartbeat and the thorough assessment I underwent before receiving my first vaccination gave me the comfort and confidence that myself and my baby were in safe hands.
“I feel more pregnant women who are on the fence or concerned about what is best to do about getting vaccinated should definitely join the study. It changed my whole pregnancy experience being pregnant during a pandemic to a more positive experience and I have felt much safer as a pregnant woman since joining.”
If you are interested in the study, or know someone who could be eligible, you can find out more by visiting the study’s website.