The Government has today accepted the recommendation from the Medicines and Healthcare products Regulatory Agency (MHRA) to authorise Oxford University/AstraZeneca’s COVID-19 vaccine for use. The Joint Committee on Vaccination and Immunisation (JCVI) has also published its latest advice for the priority groups to receive the Oxford University/AstraZeneca and the Pfizer/BioNTech vaccines. This includes updated advice for pregnant and breastfeeding women who meet other criteria for priority vaccination.
The JCVI confirms that although the available data do not indicate any safety concern or harm to pregnancy, there is insufficient evidence to recommend routine use of COVID-19 vaccines during pregnancy.
However, the JCVI now advises that if a pregnant woman meets the definition of being clinically extremely vulnerable, then she should discuss the options of COVID-19 vaccination with her obstetrician and/or doctor. This is because their underlying condition may put them at very high risk of experiencing serious complications of COVID-19. The most likely relevant groups of pregnant women are:
- Solid organ transplant recipients
- Those with severe respiratory conditions including cystic fibrosis and severe asthma
- Those who have homozygous sickle cell disease
- Those receiving immunosuppression therapies sufficient to significantly increase risk of infection
- Those receiving dialysis or with chronic kidney disease (stage 5)
- Those with significant congenital or acquired heart disease
Additionally, pregnant women who are frontline health or social care workers, including carers in a residential home, can also discuss the option of vaccination. This is because the risk of exposure to COVID-19 may be higher, even if they have a lower risk of experiencing complications if they are otherwise well.
The benefits and risks of COVID-19 vaccination in pregnancy should be discussed on an individualised basis. This should include a discussion around the lack of safety data for these specific vaccinations for pregnant or breastfeeding women, and an acknowledgement that there is no known risk associated with giving other non-live vaccines to pregnant women.
The JCVI also now advises that there is no known risk in giving these vaccines to breastfeeding women. Breastfeeding women should therefore be offered vaccination if they are otherwise eligible, for example if they are a frontline health or social care worker, including a carer in a residential home. Women should be advised that there is lack of safety data for these specific vaccinations in breastfeeding.
We welcome the recognition of pregnant and breastfeeding women as a group where clinical guidance and further research is needed. We are urgently working with the Department of Health and Social Care to set up a COVID-19 vaccine registry through the UK Obstetric Surveillance System (UKOSS) and the UK Teratology Information Service (UKTIS) for pregnancy (separate to the planned clinical trials) to ensure that adequate safety data are collected for all women in these groups who are given one of the approved COVID-19 vaccines.
We are recommending that pregnant women who might be eligible for vaccination should receive it through their maternity unit, or notify their local maternity unit when it is received. This is so that maternity staff can report it to the UKOSS/UKTIS vaccine registry, including reporting of follow-up post-vaccination of the women and their babies. The RCOG and RCM will publish further details and advice on prescribing the COVID-19 vaccination for maternity units in the coming weeks.
Dr Edward Morris, President of the Royal College of Obstetricians and Gynaecologists, said:
“This updated advice from the JCVI means that vaccination in pregnancy should be considered in women who are frontline health or social care workers or have underlying conditions that put them at very high risk of being infected with, transmitting or experiencing serious complications of COVID-19.
“We support this risk based approach until data exist to support routine vaccination in pregnant women. We also welcome the advice that breastfeeding women may be offered vaccination and that those who are trying to become pregnant do not need to avoid pregnancy after vaccination.
“For frontline health and social care workers, and other priority groups, informed decision-making should be facilitated. It is important that women continue to be offered occupational protection during pregnancy, regardless of their vaccination choice.
“Along with the Royal College of Midwives and other professional bodies, we’re calling on the UK government to fund research studies to establish the suitability of any approved COVID-19 vaccines in pregnant and breastfeeding women.
“The UK has a world leading research and development sector to support a national effort to research the vaccine’s suitability for use in pregnancy and we are calling for research trials, supported by the Vaccine Taskforce, to begin urgently to get evidence on safety. The outcomes of this research will be vital for the over 800,000 women each year who conceive, as well as the many women planning a pregnancy.”
Gill Walton, Chief Executive of the Royal College of Midwives (RCM) said:
“Today’s updated guidance from the JCVI means that clinically vulnerable pregnant women will now have access to the COVID-19 vaccination which is good news. That said the vast majority of pregnant women will not be eligible for the vaccine and this is because although the current available data does not indicate any safety concern or harm to pregnant women, there is insufficient evidence to recommend routine use of COVID-19 vaccines during pregnancy.
“Together with the Royal College of Obstetricians and Gynaecologists the RCM is calling on the Government to speed up research to assess the safety of the vaccine in pregnancy. In the meantime, all pregnant women should take up the offer of the free flu vaccination, so they are protected against flu viruses circulating this winter and if you have any concerns please talk to your midwife or GP.”
Notes to editors
This statement is supported by the Royal College of Obstetricians and Gynaecologists, Royal College of Midwives, British Maternal and Fetal Medicine Society, Macdonald Obstetric Medicine Society, UK Teratology Information Service and the National Perinatal Epidemiology Unit.
The advice from the Joint Committee on Vaccination and Immunisation (JCVI) on COVID-19 vaccination for women who are pregnant or who are breastfeeding (30 December 2020):
Women who are pregnant
There is no known risk associated with giving non-live vaccines during pregnancy. These vaccines cannot replicate, so they cannot cause infection in either the woman or the unborn child.
Although the available data do not indicate any safety concern or harm to pregnancy, there is insufficient evidence to recommend routine use of COVID-19 vaccines during pregnancy.
JCVI advises that, for women who are offered vaccination with the Pfizer-BioNTech or AstraZeneca COVID-19 vaccines, vaccination in pregnancy should be considered where the risk of exposure to Severe Acute Respiratory Syndrome coronavirus 2 (SARS-CoV2) infection is high and cannot be avoided, or where the woman has underlying conditions that put them at very high risk of serious complications of COVID-19. In these circumstances, clinicians should discuss the risks and benefits of vaccination with the woman, who should be told about the absence of safety data for the vaccine in pregnant women.
JCVI does not advise routine pregnancy testing before receipt of a COVID-19 vaccine. Those who are trying to become pregnant do not need to avoid pregnancy after vaccination.
Women who are breastfeeding
There is no known risk associated with giving non-live vaccines whilst breastfeeding. JCVI advises that breastfeeding women may be offered vaccination with the Pfizer-BioNTech or AstraZeneca COVID-19 vaccines.
The developmental and health benefits of breastfeeding should be considered along with the woman’s clinical need for immunisation against COVID-19, and the woman should be informed about the absence of safety data for the vaccine in breastfeeding women.
The MHRA has also published additional updates relating to use of the Pfizer/BioNTech vaccine in pregnancy and women who are breastfeeding.
The CHM (Commission on Human Medicines) has also reviewed further data for the Pfizer/BioNTech vaccine as it has become available and has recommended the following changes:
- Pregnancy and women who are breastfeeding - the vaccine should only be considered for use in pregnancy when the potential benefits outweigh any potential risks for the mother and baby. Women should discuss the benefits and risks of having the vaccine with their healthcare professional and reach a joint decision based on individual circumstances. Women who are breastfeeding can also be given the vaccine. This advice is in line with pregnancy and breastfeeding advice for the Oxford University/AstraZeneca vaccine
Read the RCOG/RCM Q&As for pregnant women on COVID-19 vaccines, pregnancy and breastfeeding.
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