Status
Ongoing
Title
Uptake, effectiveness and safety of COVID-19 vaccinations in pregnant women.
What is the aim of the study and why is it important?
COVID-19 has affected millions of people worldwide with major consequences for health, work and lives. Three different types of COVID-19 vaccines have been given to the UK population. Adults (including pregnant women) are eligible for a primary course of 2 (or in a minority of cases 3) vaccine doses then a booster dose.
Whilst clinical trials show vaccines to be safe and effective, it is important to see how safe these vaccines are when used in the real world. This is because the trials might not be large enough to pick up rare adverse events or pregnant women may not have been included in the clinical trials. We now know that pregnant women are at higher risk of developing more severe COVID-19 infection but are less likely to have the vaccine due to concerns about the novelty of the vaccine and the lack of safety data for their and their baby’s health. There is also some early evidence suggesting that overall, adverse outcomes in pregnancy are higher in unvaccinated women. More robust information about vaccine safety in pregnancy in the short and longer term could help pregnant women make informed decisions about vaccination. This study will help with that.
Using information routinely collected in healthcare records is one way of seeing what happens when the vaccine is given in the real world. This includes looking at whether there are symptoms or conditions recorded after any vaccine dose has been given that might suggest unexpected side effects. This study will focus on seeing how many women are vaccinated in pregnancy and how safe COVID-19 vaccines are in pregnant women and their babies overall and by each trimester of pregnancy. It will compare risks of vaccine side effects with risks after having COVID-19 infection. This will include seeing whether COVID-19 vaccinations change the chances of how pregnancies progress. It will also investigate how effective these vaccines are to reduce the risk of severe COVID-19 in pregnant women.
There are other vaccines that are given to pregnant women. Two common ones are flu and whooping cough. We will do a similar study to look at how many pregnant women get each of these vaccines and how safe they are for pregnant women and their babies.
Anonymised health records from GPs linked to vaccination information and data on COVID-19 infection, hospital admissions and maternity services contain the information needed to answer these questions quickly and on very large numbers of people. This project will assess the uptake, effectiveness and safety of COVID-19 vaccines including boosters in pregnant women to provide easily understandable timely information for clinicians, pregnant women and policy makers.
Chief Investigator
Professor Julia Hippisley-Cox
Lead Applicant Organisation Name
Sponsor
University of Oxford
Location of research
Oxford
Date on which research approved
09-Jun-2022
Project reference ID
OX316
Generic ethics approval reference
18/EM/0400
Are all data accessed are in anonymised form?
Yes
Brief summary of the dataset to be released (including any sensitive data)
QResearch database 1500 general practices in England, covering a current population of 13 million patients. This includes demographics, diagnoses, medication, laboratory investigations, pregnancy information, referrals. It is estimated that there will have been over 200,000 pregnancies in England since the start of the COVID-19 pandemic
HES care data including individual level data for hospital admissions, critical care, outpatients and A&E attendances
Individual level data for date and cause of death
Funding Source
NIHR School for Primary Care Research
Public Benefit Statement
Research Team
Dr Sharon Dixon - University of Oxford
Dr Martina Patone - University of Oxford
Professor Carol Coupland - University of Nottingham
Professor Anthony Harnden - University of Oxford
Dr Jennifer Hirst - University of Oxford
Professor Jonathan van Tam - University of Nottingham
Professor Carol Dezateux - Queen Mary University of London
Dr Brenda Kelly - Oxford University Hospitals
Professor Marian Knight - University of Oxford
Winnie Mei - University of Oxford
Dr Tom Ranger - University of Oxford
Andrew Snelling - University of Oxford
Emma Coupland - University of Oxford
Dr Judith Burchardt - University of Oxford
Approval Letter
Publications
-
Analysis of uptake, effectiveness and safety of COVID-19 vaccinations in pregnancy using the QResearch database: research protocol and statistical analysis plan
Authors: Emma Copland, Jennifer A Hirst, Tom Ranger, Winnie Xue Mei, Sharon Dixon, Carol Coupland, Kenneth Hodson, Jonathan Luke Richardson, Anthony Harnden, Aziz Sheikh, Carol Dezateux, Brenda Kelly, Marian Knight, Jonathan Van Tam, Alessandra Morelli, Joanne Enstone, Julia Hippisley-Cox
Ref:
https://www.medrxiv.org/content/10.1101/2022.12.19.22283660v1
Access Type
Trusted Research Environment (TRE)