A new study has launched to investigate the best Covid vaccine dose interval in pregnant women.
The clinical trial, funded by the government, has launched in England today (3 August) after data published last week found that no pregnant women who have had both doses of a vaccine have been admitted to hospital with Covid.
The Preg-CoV study, which will involve 600 women, is backed by £7.5m of government funding and will be led by St George’s, University of London. It will be run across 13 National Institute for Health Research (NIHR) sites across England, including London, Liverpool and Leeds.
It will provide clinical trial data on the immune response to vaccination at either a short interval or four to six weeks, or a long interval of eight to 12 weeks.
The pregnant women will need to be between 18 and 44 years old, with no health conditions, and be between 13 and 34 weeks pregnant on the day of vaccination.
Each woman will receive two doses of either the Pfizer or Moderna vaccine. They will attend nine visits and will record any symptoms in between visits.
The trial scientists will look at blood samples from both the mothers and the babies, alongside samples of breastmilk.
Minister for Covid vaccine deployment, Nadhim Zahawi, said: ‘Pregnant women are more likely to get seriously ill from Covid-19 and we know that vaccines are safe for them and make a huge difference – in fact no pregnant woman with two jabs has required hospitalisation with Covid-19.
‘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.’
Chief investigator and Professor of paediatric infectious diseases at St George’s, University of London, Professor Paul Heath said: ‘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. This includes the best schedule to use to maximally protect them against Covid-19.
‘We are extremely pleased to commence the Preg-CoV trial, which aims to fill these gaps in our knowledge and will ultimately inform policy recommendations on the optimal use of Covid-19 vaccines in pregnancy.’
It comes after the NIHR launched the UK’s first Covid vaccine study for pregnant women in May this year.