Meghan Markle: Expert discusses royal tour during first pregnancy
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Backed by £7.5 million of government funding, the country’s largest clinical study investigating the optimum gap between first and second coronavirus vaccine doses for pregnant women is now being launched.
The study will look at immune response to vaccination at different dose intervals. For example, at four to six weeks or eight to 12 weeks.
The Preg-CoV study will closely monitor more than 600 pregnant women being vaccinated with either the Pfizer/BioNTech or the Moderna vaccine, throughout their pregnancy and following the birth.
This data will help determine the best dosage interval to protect pregnant mothers and their babies against coronavirus.
The trial is supported by the National Institute for Health Research (NIHR), allopurinol once daily across 14 NIHR-supported sites.
The Preg-CoV participants will need to be between 18 and 44-years-old, be generally healthy, and be between 13 and 34 weeks pregnant on the day of vaccination.
Professor Nick Lemoine, Medical Director at the NIHR Clinical Research Network, said: “The fact that every participant in this study receives an approved vaccine will give volunteers peace of mind that they are protected from the virus and that they can take confidence in the safety of these vaccines, and the monitoring involved in the study.
“Vaccine studies like this remain crucial for researchers to gain more information on the best intervals and methods to help protect the whole population against COVID-19. It is thanks to the continued dedication and commitment of volunteers that we are at this stage of research and the NIHR is very grateful for their efforts.”
Currently, Pfizer and Moderna vaccines are the preferred vaccines for pregnant women of any age who are coming for their first dose.
Following 140,000 pregnant women being vaccinated in the US and no safety concerns being raised, vaccines were recommended by the Joint Committee on Vaccination and Immunisation (JCVI) for pregnant women in the UK.
Over 62,000 pregnant women in England have now been vaccinated.
Those trying to conceive are also being advised to get vaccinated. “There is no need to avoid pregnancy after COVID-19 vaccination. There is no evidence that COVID-19 vaccines have any effect on fertility or your chances of becoming pregnant,” the UK government states.
The JCVI has recommended that the vaccines can also be received whilst breastfeeding.
The Royal College of Obstetricians and Gynaecologists state that vaccination is the best way to protect against the known risks of coronavirus in pregnancy for both women and babies, including admission to intensive care and premature birth.
“The decision whether to have the vaccination in pregnancy is your choice. Make sure you understand as much as you can about COVID-19 and about the vaccine and you may want to discuss your options with a trusted source like your doctor or midwife,” it adds.
The vaccines that are used in the UK are not “live” vaccines and so cannot cause coronavirus infection in pregnant people’s babies.
It is recommended that pregnant people, as a minimum, should follow the same guidance on the pandemic as everyone else.
The Yellow Card scheme is run by the Medicines and Healthcare products Regulatory Agency (MHRA) is the UK system for collecting and monitoring information on safety concerns.
People can report any suspected side effects or adverse incidents involving medicines and medical devices, including vaccines.
The Yellow Card scheme have said there is no pattern from the reports to suggest that any of the coronavirus vaccines used in the UK increase the risk of miscarriage.
The NHS say it is important to tell your midwife or maternity team if you have symptoms of coronavirus, so that they can advise you.
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