A new government-funded clinical trial investigating the best Covid-19 vaccine dose interval for pregnant women, has launched in England today.
This follows on from 130,000 pregnant women being vaccinated in the US without any safety concerns raised. The Pfizer/BioNTech and Moderna vaccines have since been recommended by the independent experts at the Joint Committee on Vaccination and Immunisation (JCVI) for pregnant women in the UK.
In England almost 52,000 pregnant women have now been vaccinated with no safety concerns reported.
According to data published by NHS England and the University of Oxford last week, no pregnant women who had both doses of a vaccine, were admitted to hospital with Covid-19. Only three women were admitted after having their first dose, but 98% of those admitted to hospital have not received a jab.
The Preg-CoV study is backed by £7.5m government funding, and is led by St George’s, University of London, who will provide important clinical trial data on the immune response to vaccination at different dose intervals. This could be at either four to six weeks or eight to 12 weeks.
Minister for Covid-19 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.”
The trial will evaluate the experience of over 600 pregnant women vaccinated with either the Pfizer/BioNTech or the Moderna vaccine.
Health professionals will closely monitor the women taking part, throughout their pregnancy and after the birth, with the safety of the women taking part in the trial being their priority.
For participants to be eligible for the trial, they 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. They will receive two doses of a Covid-19 vaccine - or one dose if they’ve already had their first - at either the shorter interval of four to six weeks, or the longer interval of eight to 12 weeks.
Those taking part will be required to attend nine visits in total and will need to complete an electronic diary between visits on any symptoms. There will also be a 24-hour mobile number available for the women to contact one of the trial team at any time if they have concerns.
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.”
Blood samples from participants and one blood sample from their new-born babies, alongside samples from breastmilk, will be analysed by the scientists leading the trial.
The samples will then be used to help understand more about how the vaccines are protecting those involved from Covid-19, with initial results expected by the end of the year.
The trial will be run across 13 NIHR sites in England - including in London, Liverpool, and Leeds. All the trial sites are also working on ways to include participants from a wide variety of backgrounds, and individuals from ethnic minorities are encouraged to apply.
Dr Pat O’Brien, Vice President of the Royal College of Obstetricians and Gynaecologists, said: “We now have robust data of nearly 200,000 women from across the US and the UK, who have received the Covid-19 vaccine with no safety concerns. This tells us that both the Moderna and Pfizer vaccines are safe in pregnancy. However, more research is needed to monitor and understand how pregnant women respond to the Covid-19 vaccine.
“We welcome this trial as the next step in further monitoring the protection provided by the vaccine, to understand the risk of any potential adverse side effects, and observe the immune response within those who are pregnant and their babies.
“We are seeing more pregnant women being admitted to hospital with Covid-19, and we know that the Delta variant is causing more pregnant women to have severe illness than previous strains of the virus.
“We hope that this research will help to gain the confidence of pregnant women that the recommendation of vaccination in pregnancy is based on robust evidence.
Professor Nick Lemoine, Medical Director, NIHR Clinical Research Network, said: “The fact that every participant in this study receives an approved vaccine will give volunteers peace of mind that they are protected from the virus and that they can take confidence in the safety of these vaccines, and the monitoring involved in the study.”
The trial was commissioned by the Department of Health and Social Care through the NIHR and funded by the Vaccine Taskforce.