Vaccines ‘safe and highly effective’ for pregnant women

Extensive real-world data shows vaccines are safe and highly effective for pregnant women, the Department of Health and Social Care has announced.

The country’s largest clinical trial investigating the best gap between first and second Covid-19 vaccine doses for pregnant women launched today (August 3).

Following 130,000 pregnant women being vaccinated in the US and no safety concerns being raised, the Pfizer/BioNTech and Moderna vaccines were recommended by the independent experts at the Joint Committee on Vaccination and Immunisation (JCVI) for pregnant women in the UK.

Almost 52,000 pregnant women in England have now been vaccinated, similarly, with no safety concerns reported.

Data published last week by NHS England and the University of Oxford also shows no pregnant women who have had both doses of a vaccine have been admitted to hospital with Covid-19.

Only three have been admitted after having their first dose, meaning 98% of those admitted to hospital have not received a jab.

Health bosses say the Preg-CoV study, backed by £7.5m of government funding and led by St George’s, University of London, will provide vital clinical trial data on the immune response to vaccination at different dose intervals – either four to six weeks or eight to 12 weeks.

This data will help determine the best dosage interval and tell us more about how the vaccine works to protect pregnant mothers and their babies against Covid-19.

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.

‘I encourage anyone who is pregnant and eligible to sign-up and contribute to research that will save lives for years to come.’

Vaccines have been given to pregnant women to protect them and their babies from diseases for years, including for whooping cough and flu.

The trial will involve more than 600 pregnant women being vaccinated with either the Pfizer/BioNTech or the Moderna vaccine.

They will be closely monitored by health professionals throughout their pregnancy and following the birth, with the safety of the women taking part in the trial the utmost priority.

The Preg-CoV participants will need to be between 18 and 44 years old, have 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.

They will be scheduled to attend nine visits in total and will be required to complete an electronic diary between visits on any symptoms. They will also be given a 24-hour mobile number so they can contact one of the trial team at any time if they have concerns.

The scientists behind the trial will analyse blood samples from the participants and one blood sample from their newborn babies, alongside samples from breastmilk.

They will use the samples to help understand more about how the vaccines are protecting these individuals from Covid-19, with initial results expected by the end of the year.

The study will open for applications from volunteers today via the study’s website, with vaccinations set to start from 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.

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 encourage all pregnant women to get vaccinated, as the protection that it provides against Covid-19 to both mother and baby outweigh the risks.

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.’