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UK launches new study to find the best gap between vaccine doses for pregnant women

August 03, 2021
 The United Kingdom is launching on Tuesday (Aug. 3) the country’s largest clinical trial investigating the best gap between first and second COVID-19 vaccine doses for pregnant women, the government said in a press statement. — Courtesy file photo
The United Kingdom is launching on Tuesday (Aug. 3) the country’s largest clinical trial investigating the best gap between first and second COVID-19 vaccine doses for pregnant women, the government said in a press statement. — Courtesy file photo

Saudi Gazette report

LONDON —
The United Kingdom is launching on Tuesday (Aug. 3) the country’s largest clinical trial investigating the best gap between first and second COVID-19 vaccine doses for pregnant women, the government said in a press statement.

According to the statement, almost 52,000 pregnant women in England have so far been vaccinated, 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 percent of those admitted to the hospital have not received a jab.

The Preg-CoV study, backed by 7.5 million pounds (nearly $10.5) 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.

The trial 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.

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 analyze 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 on Tuesday 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.

The trial will be run across 13 National Institute for Health Research (NIHR) sites in England —including in London, Liverpool and Leeds. All the trial sites are working on ways of including participants from a wide variety of backgrounds and individuals from ethnic minorities are encouraged to apply.

Commenting on the launch of the new study, the UK 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 hospitalization 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 programs.”

“I encourage anyone who is pregnant and eligible to sign-up and contribute to research that will save lives for years to come,” the minister added.

Meanwhile, 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.”


August 03, 2021
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