The first UK study to determine whether the Covid vaccine is safe for pregnant women has been launched at a Newcastle hospital.
The research aims to better understand the safety and tolerability of the Pfizer-BioNTech Covid-19 vaccine in healthy pregnant women.
The study will be carried out at 11 sites of the National Institute for Health Research, including the Royal Victoria Infirmary in Newcastle, and around 235 volunteers will be involved across the UK.
Pregnant women are now offered approved vaccines alongside the rest of the UK population, depending on their age and clinical risk group.
Data from the United States has been collected in which more than 100,000 pregnant women have been vaccinated (mainly with mRNA vaccines, including Pfizer-BioNTech), without any safety concerns being raised.
The role of this placebo-controlled study is to provide more robust information about the vaccine’s immune response during pregnancy, as well as the safety reports and potential transfer of maternal antibodies to babies.
Each participant enrolled in the study will initially receive either two doses of the vaccine or a placebo 21 days apart.
Recruitment will begin this week at the relevant UK sites. Research has already been underway in the United States since February.
Moms-to-be will be required to answer questionnaires about their health, provide blood samples, complete an electronic diary, and will benefit from additional follow-up during the study, compared to those who receive a vaccine during deployment.
Volunteers from the North East will need to go to the RVI for four scheduled visits before the birth of their baby, followed by two more follow-up appointments after birth.
Participants will be identified by obstetricians and midwives at the hospital, with the study doctor determining whether each pregnant woman and their unborn baby would be suitable.
Participation is voluntary and people can leave the study at any time.
Dr Chrissie Jones, associate professor of pediatric infectious diseases at the University of Southampton, and chief investigator of the study, said: “While we have a large amount of real-world data that tells us that it is safe for pregnant women to receive Covid 19 vaccines, the data collected from a controlled research study like this is important because it will give us more information about the vaccine immune response in pregnant women, including the transfer of antibodies from maternal to infants.
“All women participating in the study will receive two doses of the approved Pfizer-BioNTech vaccine, as well as additional monitoring and support from their local research team.”
Dr Ken Hodson, principal investigator of the study at RVI Newcastle, added: “This study will help us better understand both the safety and immunogenicity of the Pfizer-BioNTech vaccine for pregnant women and infants.
“If you are over 18, between 24 and 34 weeks pregnant and have a single uncomplicated pregnancy, I invite you to contact us by calling 0191 9177485.”