Hopes UK trial will reduce pregnant women’s Covid vaccine concerns

·3-min read
Pregnant women are being recruited for a trial looking at what the best dosing gap for Covid-19 vaccine doses is (Andrew Matthews/PA) (PA Archive)
Pregnant women are being recruited for a trial looking at what the best dosing gap for Covid-19 vaccine doses is (Andrew Matthews/PA) (PA Archive)

Scientists are recruiting more than 600 pregnant women for a medical trial hoping to reassure expectant mothers on the safety of the coronavirus jab.

The new study is being launched to determine what the best gap is between coronavirus vaccine doses for pregnant women.

Researchers will monitor the vaccine’s effectiveness and follow the development of children up to one year old.

The launch comes less than a week after research revealed the vast majority of pregnant women admitted to hospital with Covid-19 are unvaccinated.

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

Those behind the 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”.

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 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.

 (PA Graphics)
(PA Graphics)

“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,” she said.

Vaccines involved initially will be the Pfizer and Moderna 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.

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