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  • Principal Investigator: Julia Hippisley-Cox
  • 1 October 2022 to 31 March 2024
  • Project No: 591
  • Funding round: FR4

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.

Amount Awarded: £228,420

Projects by themes

We have grouped projects under the five SPCR themes in this document

Evidence synthesis working group

The collaboration will be conducting 18 high impact systematic reviews, under four workstreams.