We are excited to tell you that our head of service at UKTIS, Dr Ken Hodson, is the principal investigator for a new study. This will investigate the safety and tolerability of the Pfizer mRNA Covid vaccine in pregnant women at the Royal Victoria Infirmary (RVI) in Newcastle upon Tyne. The RVI is one of 11 National Institute for Health Research (NIHR) sites* across the UK which are aiming to recruit a total of around 235 volunteers.
Currently the data on Covid vaccination in pregnancy is limited to early findings from the American v-safe Pregnancy Registry which has reported the outcomes of 827 pregnancies with exposure to mRNA COVID-19 vaccines (Pfizer-BioNTech and Moderna) (Shimabukuro et al, 2021). Whilst this data hasn’t raised any concerns, more information is ideally required. Ken says: “This study will help us to better understand both the safety and immunogenicity of the Pfizer-BioNTech vaccine for pregnant women and infants”.
Each participant enrolled in the study will initially receive either two doses of the vaccine or a placebo (saline solution) 21 days apart. At the end of the study, participants will be told which they were given and women who received the placebo will be offered the vaccine.
Recruitment recently began at the UK sites involved but the research has already been running in the US since February.
Pregnant women will be required to fill in questionnaires about their health, have some blood samples taken, and complete an e-diary. They will also receive extra monitoring while participating in the study, compared to women in the general population who receive a vaccine through the standard rollout system.
The North East volunteers will need to go the RVI for four planned visits before their baby is born and then two more follow up appointments after the birth. However, taking part is voluntary and people can leave the study at any time.
If you are over 18, between 24-34 weeks pregnant, have a single uncomplicated pregnancy and would be interested in taking part in this important study at the RVI, you are invited to contact the study team by calling (0191) 917 7485.
*The other 10 study sites are listed below. For more information about participating in this trial at these sites please complete and submit this form Pfizer Clinical Trial Information Request (pmiform.com)
• St Thomas’ Hospital- Guy’s and St Thomas’ NHS Foundation Trust
• St James’ University Hospital - The Leeds Teaching Hospitals NHS Trust
• St Mary’s Hospital - Imperial College Healthcare NHS Trust
• University College London Hospitals NHS Foundation Trust
• King’s College Hospital NHS Foundation Trust
• St George’s University Hospital Foundation Trust
• John Radcliffe Hospital - Oxford University Hospitals NHS Trust
• Medway Maritime Hospital - Medway NHS Foundation Trust
• Western General Hospital - NHS Lothian
• Southampton General Hospital - University Hospital Southampton NHS Foundation Trust
For more information about Covid-19 vaccines in pregnancy please see our BUMPs patient information leaflet.