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Uptake, effectiveness and safety of COVID-19 vaccinations in pregnant women.




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


University of Oxford

Location of research


Date on which research approved


Project reference ID


Generic ethics approval reference


Are all data accessed are in anonymised form?


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


  • 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

Access Type

Trusted Research Environment (TRE)

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