Pregnant women called upon for COVID-19 vaccine study in Greater Manchester to shape future national and international guidance

A national COVID-19 vaccine study is urging pregnant women across Greater Manchester to step forward and help researchers discover the most effective use of vaccines during pregnancy to protect women and their babies against COVID-19. To identify the best interval between vaccine doses, during and following pregnancy, more volunteers are urgently needed to join the Preg-CoV study.

Ran at Saint Mary’s Hospital, part of Manchester University NHS Foundation Trust (MFT) and the National Institute for Health Research (NIHR) Manchester Clinical Research Facility (CRF) – which is hosted by MFT – at Royal Manchester Children’s Hospital (RMCH), the study compares vaccines 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.

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 you and your baby from COVID.

Data from Public Health England showed that more than 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.

Currently, more than 30 pregnant women have volunteered to join the study, but hundreds more 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.

Dr Teresa Kelly, Consultant Obstetrician at Saint Mary’s Hospital and Principal Investigator for Preg-CoV at MFT, said: “Unfortunately pregnant women are more likely to develop severe COVID-19. We know coronavirus vaccination is safe in pregnancy and is recommended.

We are incredibly appreciative of our participants in this important study, which will help to inform national strategies on the most effective interval between doses, in pregnancy.

Professor Paul Heath, Chief Investigator and Professor of Paediatric Infectious Diseases at St George’s, University of London, 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. But 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.

“We need even more pregnant women across the country to join the study. Not only will they receive special monitoring and support around their vaccines, but they will help shape future guidelines and protect pregnant women in the future. It is a really worthwhile, helpful thing to do.”

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.

Recent data shows one in five of the most critically ill COVID-19 patients are pregnant women who have not been vaccinated.

Professor Lucy Chappell, Chief Scientific Adviser for the Department of Health and Social Care, NIHR Chief Executive and Professor of Obstetrics at King’s College London, said: “Nationally we’re concerned about the increase of pregnant women needing intensive care unit care and hospitalisation. We understand that pregnant women have been hesitant about taking the COVID-19 vaccine. But we would really like to encourage all pregnant women and those considering pregnancy to get vaccinated so that we can see an impact in these numbers coming down.

“We have seen data on effectiveness and safety of vaccination in pregnancy coming through from around the world, following up on the hundreds of thousands of pregnant women who have received COVID-19 vaccines.

The Preg-CoV study team is leading on this research in the UK to help us gather further information so that we can continue to provide the most accurate advice to parents and parents to be.

Once successfully enrolled, most participants will be randomised to receive two doses of an approved COVID-19 vaccine with either a short-time interval (four to six weeks) or a long-time interval (eight to 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 (third dose). All participants and their babies will be followed up until one year after delivery.

The study is seeking low-risk, carrying a single baby, pregnant women aged 18 to 45 years-old and between 13 to 34 weeks gestation. It is also recruiting participants who have already had two doses of a COVID-19 vaccine in the community.

Debbie, a volunteer on the study, said: “Becoming pregnant during the pandemic, my main concern was will my baby be okay. So in fact, it was only after joining the study that I slowly began to relax and begin to enjoy my pregnancy with less stress and fear around COVID.

“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.”

Georgina, another participant in the study, explained: “It is both interesting and rewarding to take part in this study. I wanted to get involved because I wanted to give something back.

When the trial came about it seemed like the perfect opportunity to help medical research, while also getting vaccinated and extra care in my pregnancy.

The study will collect blood samples from participants, with a cord blood sample taken after delivery for some participants. For all participants, a baby blood sample will be taken between four and 12 weeks of age. Breastmilk samples will also be collected for a sub-group of participants.

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.