Preg-CoV study to provide data on immune response to vaccination at different dose intervals
A new £7.5 million government-backed study will investigate what the best gap is between first and second Covid-19 vaccine doses for pregnant women.
The news comes after another research study revealed that 99 per cent of pregnant women admitted to hospital with symptomatic Covid-19 are unvaccinated.
Led by St George’s, University of London, the Preg-CoV study will provide data on the immune response to vaccination at different dose intervals—either four to six weeks or eight to 12 weeks—the National Institute for Health Research announced on 3 August.
NIHR said that pregnant women are more likely to develop severe Covid-19 or die from the disease, but are usually excluded from clinical trials with new vaccines, which means there is “very limited clinical trial data on the immune response and side effects caused by the vaccines for these women”.
“Tens of thousands of pregnant women have now been vaccinated in both the US and the UK with no safety concerns reported, but we still lack robust, prospective clinical trial data on Covid-19 vaccines in pregnant women,” said Paul Heath, the study’s chief investigator and a professor of paediatric infectious diseases at St George’s. “This includes the best schedule to use to maximally protect them against Covid-19.”
He said the trial aims to fill these gaps in knowledge and “will ultimately inform policy recommendations on the optimal use of Covid-19 vaccines in pregnancy”.
The study will involve more than 600 pregnant women being vaccinated with either the Pfizer/BioNTech or the Moderna vaccine, who will be closely monitored throughout their pregnancy and following the birth.
It was commissioned by the Department of Health and Social Care through the NIHR and is now open for applications from volunteers, with vaccinations due to start in mid-August.
Participants will also be recruited to the study by invites sent through the NHS Covid-19 Vaccine Research Registry, which allows research teams to speak to suitable volunteers who have signed up to be contacted about taking part in vaccine studies.