Study launched to find best Covid vaccine gap for pregnant women

Pregnant women are more likely to develop serious illness from infection, experts say

Matt Mathers
Tuesday 03 August 2021 12:36
Comments

A clinical trial is being launched to determine the best time to give pregnant women their second dose of a Covid vaccine, the government has announced.

Under current guidance, most people are told to leave a gap of at least eight weeks between their first and second jabs.

Researchers will analyse whether or not this is best practice for expectant mothers.

The move is announced just days after Oxford University published new data showing that 99 per cent of pregnant women being admitted to hospital with the disease are unvaccinated.

Studies show pregnant women are also more likely to develop serious illness from Covid.

The official study, starting on Wednesday, will involve over 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.

Those behind this latest Preg-CoV trial said while there are currently no safety concerns when it comes to pregnant women having Covid-19 jabs, they hope it will give expectant mothers and those caring for them "the highest quality of data about these vaccines".

England's chief midwife has written to GPs and fellow midwives across the country urging them to encourage expectant mothers to get a jab.

Almost 52,000 pregnant women in England have been vaccinated to date - with no safety concerns reported.

The trial - the UK's largest investigating the best gap between first and second doses for pregnant women - involves £7.5 million 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 a lesson to be learned from this pandemic is "the need for including pregnant women in vaccine trials at an earlier stage" and acknowledged such a trial "could have started six months ago".

Professor Asma Khalil, lead obstetrician for the trial and professor of obstetrics and maternal fetal medicine at St George's, said the most common question from pregnant women is whether they should get the vaccine.

She said while there is data showing no safety concerns following vaccination in pregnant women, there remains a worry among patients 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."

Vaccines involved initially will be the Pfizer/BioNTech and the Moderna vaccine but other new vaccines will be included as they are approved in the future.

Women aged 18 to 44 will be recruited from some 15 sites across England if they are between 13 and 34 weeks gestation at the time of vaccination.

They will randomly receive one of the vaccines either at a four to six week dosing gap or the longer eight to 12 week dosing gap.

The first trial results, looking at any adverse events following a first dose, should be available towards the end of the year, while immune response results are expected in the first quarter of next year.

Dr Pat O'Brien, vice president at the Royal College of Obstetricians and Gynaecologists, said the findings of the study are likely to be relevant "for many years to come".

He said: "This is an important study. We feel comfortable with the safety of these vaccines. What we want to understand now is how to fine-tune them, to understand better how they work. What's the optimal way of giving them?

"Do they work as well in pregnant women as in other people? 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: "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."

Last week researchers at Oxford University described findings of their work as "concerning", saying that one in 10 pregnant women admitted to hospital with symptoms of Covid-19 often require intensive care.

Marian Knight, professor of maternal and child population health at the Nuffield Department of Population Health, University of Oxford, and chief investigator of the study, said pregnant women can be "reassured" about the safety of the vaccines and that antibodies will be passed to their babies.

According to the latest available figures, more than 46 million people in the UK have had one vaccine dose, while more than 38 million have had both jabs.

Additional reporting by Press Association

Register for free to continue reading

Registration is a free and easy way to support our truly independent journalism

By registering, you will also enjoy limited access to Premium articles, exclusive newsletters, commenting, and virtual events with our leading journalists

Please enter a valid email
Please enter a valid email
Must be at least 6 characters, include an upper and lower case character and a number
Must be at least 6 characters, include an upper and lower case character and a number
Must be at least 6 characters, include an upper and lower case character and a number
Please enter your first name
Special characters aren’t allowed
Please enter a name between 1 and 40 characters
Please enter your last name
Special characters aren’t allowed
Please enter a name between 1 and 40 characters
You must be over 18 years old to register
You must be over 18 years old to register
Opt-out-policy
You can opt-out at any time by signing in to your account to manage your preferences. Each email has a link to unsubscribe.

Already have an account? sign in

By clicking ‘Register’ you confirm that your data has been entered correctly and you have read and agree to our Terms of use, Cookie policy and Privacy notice.

This site is protected by reCAPTCHA and the Google Privacy policy and Terms of service apply.

Join our new commenting forum

Join thought-provoking conversations, follow other Independent readers and see their replies

Comments

Thank you for registering

Please refresh the page or navigate to another page on the site to be automatically logged in