Scientists will study the best gap between coronavirus vaccine doses for pregnant women in a bid to increase confidence in the jabs.
More than 600 pregnant women will be recruited for the trial which will see the vaccine’s effectiveness monitored, along with the child’s development to the age of one.
Scientists hope the study will reassure pregnant women about the safety of the jab, less than a week after research revealed that most pregnant women admitted to hospital with COVID-19 have not been vaccinated.
Almost 52,000 pregnant women in England have been vaccinated and no safety concerns have been reported.
The Preg-CoV trial – the UK’s largest investigating the gap between doses for pregnant women – involves £7.5m of government funding and is being led by St George’s, University of London.
Professor Paul Heath, chief investigator and professor of paediatric infectious diseases at St George’s, said: “The coverage (uptake) of vaccination in pregnancy at the moment is disappointing, it’s low – less than a third.
“I suspect that one of the reasons for that is that they do not feel confident enough about vaccination. Perhaps participating in a trial will give them that confidence.”
He said he hoped the pandemic had taught scientists of the need to include pregnant women in vaccine trials “at an earlier stage”, adding that such a trial “could have started six months ago”.
Professor Asma Khalil, lead obstetrician for the trial and professor of obstetrics and maternal foetal medicine at St George’s, said that, despite data showing no safety concerns following vaccination in pregnant women, patients remain concerned because pregnant women were not included in initial COVID-19 vaccine trials.
She said: “The data we have are good, and provide some safety reassurance but what we want to aspire to is the top quality, the high quality data from randomised controlled trials which this trial will provide.”
The vaccines by Pfizer and Moderna will be involved initially but other vaccines can be included as they are approved.
To participate in the trial, women must be aged between 18 and 44 and between 13 and 34 weeks’ gestation when they are vaccinated.
They will be recruited from 15 sites in England and will be vaccinated with either a four-to-six-week gap or an eight-to-12-week gap.
The first set of result will be available later this year and will look at any adverse effects, while results showing immune responses will come in the first quarter of next year.
Dr Pat O’Brien, vice president at the Royal College of Obstetricians and Gynaecologists, said the study’s findings would be relevant “for many years to come”.
He said: “Bear in mind this pandemic is likely to become endemic, this is likely to be ongoing. So I suspect that the findings from this trial will be relevant to us, to pregnant women for many years to come.”
Vaccines minister Nadhim Zahawi said: “This government-backed trial will provide more data about how we can best protect pregnant women and their babies, and we can use this evidence to inform future vaccination programmes.
“I encourage anyone who is pregnant and eligible to sign up and contribute to research that will save lives for years to come.”
WHICH SITES ARE PART OF THE TRIAL?
• St George’s University Hospitals NHS Foundation Trust (London)
• University Hospital Southampton NHS Foundation Trust
• St Michael’s Hospital, University Hospitals Bristol and Weston NHS Foundation Trust
• Liverpool Women’s NHS Foundation Trust
• Leeds General Hospital, Leeds Teaching Hospitals NHS Trust
• St Helier Hospital, Epsom and St Helier University Hospitals NHS Trust
• Hammersmith Hospital, Imperial College Healthcare NHS Trust (London)
• Princess Royal Hospital, Shrewsbury and Telford Hospital NHS Trust
• Royal Free NHS Foundation Trust (London)
• The Royal Cornwall Hospitals NHS Trust
• Royal Preston Hospital, Lancashire Teaching Hospitals NHS Foundation Trust
• Manchester University NHS Foundation Trust
• Birmingham Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust
It is understood two more sites are awaiting confirmation.
