The COVID-19 vaccine is being rolled out around the world as we continue to fight the spread of the coronavirus, but it’s not entirely clear whether pregnant and breastfeeding women can have the vaccine. Here’s what we know so far…
For many of us muddling through this strange and stressful time, news of the COVID-19 vaccine is a shining ray of light at the end of a long, dark tunnel. However, while pregnant women in the USA have been told they have the choice to take the vaccine, in the UK there has been confusing language around whether or not pregnant or breastfeeding woman should be having the vaccine.
In a recent update, the Joint Committee on Vaccination and Immunisation announced breastfeeding women could have the vaccine, if they are otherwise eligible. Meanwhile, pregnant women are advised not to take it, unless they have been deemed ‘clinically extremely vulnerable.
So, here’s what we know so far…
Who can have the vaccine in the UK?
At the time of writing, the COVID-19 vaccine is being rolled out to those at the highest risk in the UK.
According to the NHS website, the vaccine is being offered in some hospitals and local vaccination centres to:
- some people aged 80 and over who already have a hospital appointment in the next few weeks
- people who live or work in care homes
- health care workers at high risk
If you are pregnant in the UK, you are deemed at moderate risk- this is the same category as over 70s and those with underlying health conditions such as diabetes. pregnant and breastfeeding women in the UK are currently advised not to have the vaccine.
Why can’t pregnant Women have the COVID-19 vaccine in the UK?
In a statement, the Medicines and Healthcare products Regulatory Agency (MHRA) explained, “The clinical trials for the Pfizer/BioNTech Covid-19 vaccine did not include pregnant or breastfeeding women,” resulting in a lack of data surrounding pregnancy, breastfeeding and the vaccine.
With this in mind, the issue is not the vaccine has been deemed unsuitable for pregnant and breastfeeding women, but that there simply isn’t enough data to prove otherwise.
The statement continues: “Therefore, as a precautionary measure our recommendation is that the vaccine should not be given to pregnant or breastfeeding women until more data is available.
“These judgements reflect the absence of data at the present time and do not reflect a specific finding of concern. Further studies on this are planned, the results of which will be provided when available, and the guidance will be changed accordingly – if appropriate.”
What does this actually mean if you’re pregnant in the UK?
The MHRA and Public Health England’s latest advice states:
- if you are pregnant you should not be vaccinated – you can be vaccinated after your pregnancy is over
- if you think you may be pregnant you should delay vaccination until you are sure you are not
- if you are planning to get pregnant in the next 3 months, you should delay your vaccination
- if you know you are not pregnant you can start the two-dose course now and you should avoid getting pregnant until at least 2 months after the second dose
- if you have had the first dose and then become pregnant you should delay the second dose until after the pregnancy is over
Yet, according to Public Health England’s latest guidelines on COVID-19 and pregnancy, the evidence so far reviewed by the MHRA raises no concerns for safety in pregnancy. In fact, the NHS website explains, “if you later find out you were pregnant when you had the COVID-19 vaccine, do not worry. The vaccine cannot give you or your baby COVID-19.
“There’s no evidence it’s unsafe if you’re pregnant or breastfeeding. But more evidence is needed before you can be offered the vaccine.”
However, the government’s guidelines err on the side of caution and reiterate that there simply isn’t yet enough data to make a clear decision on whether pregnant and breastfeeding women in the UK should be encouraged to have the vaccine. The MHRA has also called for more non-clinical data before finalising the official advice regarding the vaccine in pregnancy.
“It is standard practice when waiting for such data on any medicine, to avoid its use in those who may become pregnant or who are breastfeeding,” a statement by Public Health England reads.
According to RCOG, The Joint Committee on Vaccination and Immunisation (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 is deemed ‘clinically extremely vulnerable’, then she may qualify for the option of a COVID-19 vaccination. 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 below:
- 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
- Those with significant congenital or acquired heart disease
What about breastfeeding women? Why are they grouped with pregnant women?
When it comes to clinical trials, new medicines and vaccinations, breastfeeding and lactating women are usually grouped together with pregnant women. This also the case with the COIVD-19 vaccine.
In updated guidelines published on 30th December 2020, 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,” the RCOG website claims.
The JCVI does stipulate that women should be advised that there is lack of safety data for these specific vaccinations in breastfeeding.
However, there is some concern that in placing breastfeeding women in the same category as pregnant women when it comes to clinical trials and government guidelines, the advice is too broad. Additionally, in doing so, some medical professionals fear women will thus be under undue pressure to either stop breastfeeding or put themselves at a higher risk of COVID-19 by abstaining from the vaccine.
Speaking to WIRED, Joeli Brearley, founder of Pregnant Then Screwed, a group that campaigning against pregnancy and maternity discrimination, explained: “We’ve been talking to breastfeeding doctors who are really concerned that they feel under pressure to either stop breastfeeding or put themselves at risk of COVID-19.”
What about in America? Reports say pregnant women in the US can have the vaccine.
In excluding pregnant and lactating women from clinical trials, Pfizer/BioNTech and other providers are acting in accordance with US regulators such as Food and Drug Administration (FDA) and the Centres for Disease Control (CDC) as standard with any new medicine or vaccination. However, in the US the decision has been made to recognise these are not normal times.
Instead, regulators in the US have approved the use of the vaccine on pregnant women who are deemed particularly risk, and where the benefits of the vaccine far outweigh the risks to the mother or the foetus.
“The experts came to a consensus view that scientific plausibility of harm just wasn’t there,” Dr Ruth Faden, a bioethicist at Johns Hopkins University told the BBC. Dr Faden went on to stipulate, however that this “doesn’t mean zero”.
What about the vaccine and fertility?
In short, the COVID-19 vaccine does not affect fertility, however, a combination of confusing language, misinformation and initial un-founded fears that the antibodies could attack the placenta have lead to concerns swirling about fertility and the vaccine.
According to a public document, released by the government for healthcare professionals concerning the Pfizer/BioNTech vaccine, it claimed that it was ‘unknown’ the COVID-19 vaccine had an affect on fertility.
This guidance has since been updated and now states: “There is limited experience with use of the COVID-19 mRNA Vaccine BNT162b2in pregnant women,” the government explains in the document. It also adds that initial ‘animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity’.
In an attempt to debunk this somewhat confusing language, Dr Victoria Male, a lecturer in reproductive immunology at Imperial College London, told The I that full fertility studies are not generally done on new vaccines or medications before they are rolled out.
She went on to explain that based on the Pfizer efficacy and safety trials and the science behind the vaccine, there is no need for concern: “No one who is serious about vaccines or immunology is worried about this.”
Dr Male also adds that if the claims that the small stretch of amino acids in the spike protein – the part of the virus in the Pfizer vaccine that tells our bodies to attack – was going to attack the placenta, we would have seen this happening when women contracted the vaccine originally.
“We have evidence this doesn’t happen, because we are now seeing people becoming pregnant having had COVID-19 in the spring,’ she confirmed to The I.