New coronavirus vaccine trial for pregnant women
It is aiming to recruit over 600 mums-to-be nationwide, to determine the best gap between doses
A new study is being launched to determine what the best gap is between coronavirus vaccine doses for pregnant women, with scientists hoping findings will reassure expectant mothers on the safety of the jabs.
Researchers are aiming to recruit more than 600 pregnant women for the trial, which 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 fellow midwives across the country urging them to encourage expectant mothers to get a jab.
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”.
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 and involves 12 other hospital trusts across the UK.
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".
How will the trial work?
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.
The Covid-19 vaccines
What is the Pfizer-BioNTech vaccine?
The Pfizer-BioNTech vaccine was approved for use in the UK on 2 December 2020. Britain was the first country in the world to approve the jab, which offers up to 95% protection against Covid-19. Pfizer is an American pharmaceutical firm while BioNTech is a German biotechnology company. The vaccine is very delicate and has to be stored at -70 degrees, limiting the number of sites that can administer the jab.
What is the Oxford/AstraZeneca vaccine?
A vaccine developed by Oxford University and pharmaceutical company AstraZeneca became the second vaccine approved for UK use on 30 December 2020. This vaccine was considered "the way out" of the pandemic in the UK, thanks to the fact it is easier to store than the Pfizer jab, making it well equipped for mass roll out. GPs and vaccination centres across the country began administering the jab in early January 2021. Under 30's in the U.K. were given the option to choose a different vaccine to this due to small risks of very rare blood clots. Instead, under-30s would typically choose the Pfizer jab or later, the moderna jab.
What is the Moderna vaccine?
The third vaccine approved for UK use on 8 January 2021 was developed by American firm Moderna. 24-year-old Elle Taylor from Wales became the first person in the UK to receive the Moderna jab in April. The Moderna vaccine is similar to the Pfizer jab in how it works but is even easier to roll out as it can be stored at -20 degrees rather than -70.
What is the Johnson & Johnson vaccine
The fourth vaccine to be be approved in the UK was Johnson & Johnson's vaccine, released under the name Janssen. Notably, It is also the first single shot vaccine in use during this vaccine rollout.
Who was the first person to receive the Pfizer vaccine?
90-year-old Margaret Keenan became the first patient in the world to be vaccinated against Covid-19 outside a clinical trial. She received her jab on 8 December 2020 at Coventry's University Hospital. Mrs Keenan, who lives in Coventry, became somewhat of a fashion influencer after the charity t-shirt she wore to her vaccination appointment sold out. Profits went towards buying Christmas presents for hospital patients. The grandmother advised everyone who was offered the vaccine to take it, saying "If I can have it at 90, then you can have it too."
Who was the first person to receive the Oxford vaccine?
Meanwhile, Brian Pinker from Oxford was first to receive the AstraZeneca jab outside of a clinical trial at the age of 82. Mr Pinker, who was vaccinated on 4 January 2021, praised the medical teams administering the vaccine, saying it would allow him to "really look forward" to celebrating his 48th wedding anniversary with wife Shirley later on in the year.
When will I receive the vaccine?
Vaccines were offered according to vulnerability levels. First to be offered the jab were people in care homes and their carers, followed by those over 80 and health and social care workers. People aged 65 and above were next on the priority list and then high-risk adults under the age of 65 followed by moderate risk adults under 65. The vaccine was then rolled out by age group.
How will I know when it's my turn to get vaccinated?
When it is your turn to receive the vaccination, you will be informed by the NHS. You should only attend vaccination sites if you have been told to do so. Vaccines are provided for free by the NHS and they will never ask for bank details. Find out more about vaccine scams here.
What is a vaccine passport?
The Government debate the idea of a vaccine passport as proof of full vaccination required to enter venues like nightclubs. Health Secretary Sajid Javid later "ditched" the idea and ensured clubbers that they no longer need to be double jabbed by the end of September 2021 to get into Nightclubs or big events.
Do I need a booster jab?
Pfizer/BioNTech booster jabs are rolled out as part of the Government's winter covid plan. Shots can be given to people aged 50 and over, those in care homes and frontline health and social care workers. All those who are clinically extremely vulnerable and anyone aged 16 to 65 in an at-risk group for Covid will also be eligible for a jab. There must be at least 6 months between a 2nd vaccine dose and a booster jab.
Oxford jab scientist Sarah Gilbert says booster jabs are "not needed for all" and that they should instead go to countries with low vaccination rates.
Will children be vaccinated?
The government have also made vaccines available to children aged between 12-15 as part of the country's winter Covid plan.
What about five to 11-year-olds getting vaccinated?
All 5 to 11-year-olds in England can now receive a coronavirus jab, following advice from the JCVI and the same decision being made in Scotland and Wales. Northern Ireland is also expanding their vaccination programme to include the 5-11 age range. It means almost six million children in the UK will be offered the Covid-19 vaccination.