UK News Trial to find the best gap between vaccine doses for pregnant women

04:05  03 august  2021
04:05  03 august  2021 Source:   news.sky.com

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HUNDREDS of pregnant women have been urged to come forward to participate in a Covid vaccine trial . Today the government announced it would be investing £7.5 million into the study which will help determine the best gap between jabs for pregnant women . The Preg-CoV study will be led by a team at St George’s, University of London and will provide vital data on the immune response to vaccination at different dose intervals - either four to six weeks or eight to 12 weeks. The trial will involve 600 pregnant women and they will be given jabs that have already been approved for use

There’s limited information about how well the vaccines work outside that time frame, the CDC said. CNN said the new CDC guidance “appears to clarify earlier language that said ‘there is no maximum interval between the first and second doses for either vaccine .’ ” The guidance is significant because the CDC had advised states not to hold back vaccines for second shots so that a maximum number of people can get the first dose .

Scientists will study the best gap between coronavirus vaccine doses for pregnant women in a bid to increase confidence in the jabs.

There are concerns that many pregnant woman are not getting vaccinated against COVID-19 © Other There are concerns that many pregnant woman are not getting vaccinated against COVID-19

More than 600 pregnant women will be recruited for the trial which will see the vaccine's effectiveness monitored, along with the child's development to the age of one.

Scientists hope the study will reassure pregnant women about the safety of the jab, less than a week after research revealed that most pregnant women admitted to hospital with COVID-19 have not been vaccinated.

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Although pregnant women are at no greater risk of being infected by the virus, they are more likely to have complications from Covid-19. Data shows that one in five pregnant women who become unwell with Covid needs to have her baby delivered early. As the UK's vaccination programme is now inviting people in their 40s, clarity on advice for pregnant women on the vaccine was needed. More than 32 million people in the UK have received a first dose of a Covid vaccine . Women who are planning pregnancy or are breastfeeding can be vaccinated with any vaccine , depending on their age and

Previously, only pregnant women at high risk of infection were advised to consider the shot. The updated medical advice was issued on Wednesday by the Australian Technical Advisory Group on Immunisation (ATAGI), an expert health panel advising the Australian government, and the Royal Australian and New Zealand College of Previous health advice had recommended that pregnant women at high risk of contracting Covid-19 – such as healthcare workers, or those with medical conditions that made them more vulnerable to the disease – needed to consider seeking vaccination .

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

The Preg-CoV trial - the UK's largest investigating the gap between doses for pregnant women - involves £7.5m 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 the pandemic had taught scientists of the need to include pregnant women in vaccine trials "at an earlier stage", adding that such a trial "could have started six months ago".

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Vaccines that contain live viruses aren't recommended for pregnant women . Two vaccines are routinely recommended during pregnancy : Flu (influenza) shot. Getting the flu shot and the Tdap vaccine during pregnancy can protect you from infection and can also help protect your baby after birth before he or she can be vaccinated . This is important because the flu and whooping cough can be particularly dangerous for infants. If you're at increased risk of certain infections, your health care provider might also recommend other vaccines during pregnancy — such as the hepatitis B vaccine .

“While pregnancy puts women at a higher risk of severe COVID-19, the use of this vaccine in pregnant women is currently not recommended,” SAGE wrote. The report also stressed that the vaccine should be administered in two doses with an interval of 28 days between each shot, with the possibility of extending this interval up to 42 days if necessary. The SAGE report also emphasised the need for the vaccine to be administered in facilities where treatments for allergic reactions are readily available.

Professor Asma Khalil, lead obstetrician for the trial and professor of obstetrics and maternal foetal medicine at St George's, said that, despite data showing no safety concerns following vaccination in pregnant women, patients remain concerned 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."

The vaccines by Pfizer and Moderna will be involved initially but other vaccines can be included as they are approved.

To participate in the trial, women must be aged between 18 and 44 and between 13 and 34 weeks' gestation when they are vaccinated.

They will be recruited from 15 sites in England and will be vaccinated with either a four-to-six-week gap or an eight-to-12-week gap.

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Out of the 127 women receiving vaccines during their first or second trimesters, 104 spontaneous abortions occurred before their pregnancies hit the 20-week mark. These are indicated as “spontaneous abortions” in the table. We call for a review of all his methods and conclusions. Perhaps this same study architect has made the same systematic error (or possibly a deliberate obfuscation) for many years, spanning many previous studies. It wouldn’t be the first time one author was found to have made systematic mistakes across dozens of papers and is forced to retract them.

Pregnant women were not included in the test subject populations for Phase 3 trials for any of the currently released Covid vaccines . The reason was because it wasn't known then what effect the vaccine would have on a fetus. In January, 2021 the World Health Organization expressed concern about pregnant women being inoculated with a Covid-19 vaccine , either from Pfizer, or from Moderna. The reasoning is purely precautionary, and is not based on adverse medical effects of the mothers, or their unborn children.

The first set of result will be available later this year and will look at any adverse effects, while results showing immune responses will come in the first quarter of next year.

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

He said: "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: "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."


• St George's University Hospitals NHS Foundation Trust (London)

• University Hospital Southampton NHS Foundation Trust

• St Michael's Hospital, University Hospitals Bristol and Weston NHS Foundation Trust

• Liverpool Women's NHS Foundation Trust

• Leeds General Hospital, Leeds Teaching Hospitals NHS Trust

• St Helier Hospital, Epsom and St Helier University Hospitals NHS Trust

• Hammersmith Hospital, Imperial College Healthcare NHS Trust (London)

• Princess Royal Hospital, Shrewsbury and Telford Hospital NHS Trust

• Royal Free NHS Foundation Trust (London)

• The Royal Cornwall Hospitals NHS Trust

• Royal Preston Hospital, Lancashire Teaching Hospitals NHS Foundation Trust

• Manchester University NHS Foundation Trust

• Birmingham Heartlands Hospital, University Hospitals Birmingham NHS Foundation Trust

It is understood two more sites are awaiting confirmation.

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This is interesting!