The extraordinary rapid development of multiple Covid-19 vaccines in 2020 may come to be seen as one of the great scientific advances. The early release of viral samples by China allowed very rapid genome sequencing. Pharmaceutical companies have been able to employ new techniques and huge computing power to design vaccines in a matter of weeks rather than years. Streamlined trial processed allowed the companies to gather vast amounts of data, analyse it, and produce the vaccines. However, speaking to patients, there is an understandable desire to know about what the long term consequences of these vaccines might be.

How do the vaccines work? 

In essence, a vaccine is trying to teach your immune system what the virus looks like so that it can recognise it quickly when it appears in your body for real. Think of it as an infectious diseases ‘Most Wanted’ board, hung up in your own body. Covid-19 is the current most wanted criminal. The other photos you have on that board from your previous vaccinations have been created by injecting weakened live viruses, or particles from their surface. The novel approach in this pandemic has been to use DNA or RNA from the virus itself. Crucially this is doing absolutely nothing to modify your own DNA – it can’t possibly do so. It does however put a picture of the COVID-19 spike protein into clever cells called B cells, which uses its own “photocopier” to make lots more pictures of this viral criminal (antibodies) to spread around the body. They even effectively “laminate” some of them and keep them filed away for future reference (a long-lasting antibody type called IgG). 

Are the vaccines effective? 

In a word, yes. The original target set for the drug companies by the WHO was 50% effectiveness. There was much talk about the fact that 9 out of 10 drugs in trials turn out to be ineffective – the vaccine trials to have blown these stats out of the water! Even the lowest quoted figures in the 70s per cent are excellent results, and 95% from Pfizer and Moderna is astonishingly good!

It is also worth noting that, although the University of Oxford/ Astra-Zeneca trial reported lower efficacy than Pfizer and Moderna Vaccines the University of Oxford/ Astra-Zeneca screened for asymptotic infection as well as symptomatic COVID-19 which the others did not. 

Why is it so important we know how the COVID vaccines affect pregnancy?

We know from current research that pregnant women are at increased risk of complications from Covid-19  compared to women who are not pregnant. This is particularly the case in the second half of pregnancy. Pregnant women are at increased risk of having a preterm delivery if they contract covid-19. The babies of women who have had covid-19 are 3 times more likely to be admitted to hospital.

Despite the risk of these complications, pregnant women have not been put in a high priority group for the covid-19 vaccination. Out of an abundance of caution, pregnant women were excluded from the early trials into the covid-19 vaccination. However, this did miss out on the opportunity to generate safety data on giving the vaccine in pregnancy. 

Why might pregnant women not want to be vaccinated?

It is entirely understandable that people would be cautious with a new vaccine. Based on what we know about how these vaccines work they do seem unlikely to pose a risk to the pregnant person or the fetus because they are not live vaccines. Currently, there is no known significant risk from giving non-live vaccines to pregnant women. Studies are underway on those who have already had the vaccine in pregnancy (healthcare workers and people shielding due to medical conditions) and are underway on more pregnant women. But until these are completed, we won’t know for sure. 

What is the situation in the UK regarding vaccinating pregnant women?

Since the majority of pregnant women will fall into the latter groups to be offered the vaccine it’s likely more information will be available at the time. So, do ask later this year if you have any concerns. You can be sure that if it transpires there is any risk this will be fully explained to you before anyone gives you a jab. Ultimately turning up for your jab is likely to be one of the best places to get the most up to date information. One of the very short list of mandatory questions we have to ask you before giving the vaccine is asking if you are pregnant. As the vaccinator you can’t even see the next screen without confirming the answers to these questions so nobody will vaccinate you without first getting your consent! 

The current advice in the UK is that although there is currently no evidence to suggest the vaccine would cause harm in pregnancy, there is not sufficient data to routinely recommend its use in pregnancy. However, it is recommended that pregnant women who are extremely clinically vulnerable or pregnant women who are frontline health or social care workers should discuss the risk and benefits of the vaccine with their doctor. 

What are other countries doing?

• On 25 Jan the International Committee of Medicine Regulatory Authorities met to discuss, amongst other things, this very issue – they looked at ongoing large international studies of Covid vaccine safety in pregnancy and no concerns have been raised following this meeting and a furthermore specialised the following week. 
• In America, the CDC has issued guidance along similar lines as here in the UK.  Essentially, they recommend that you have the jab, but that is a personal choice and to make sure you’ve discussed your concerns with your provider first.
• The HSE in Ireland has added the precaution that if you discover you are pregnant after having your first jab you should wait until the 14-week point of your pregnancy to have your second – this is to avoid any association with possible miscarriage which becomes much less likely after that point. 
• In Europe, the EMA has advised waiting until the outcome of the studies is known before offering pregnant women their vaccine.
• Israel, who are further along in their vaccination programme than other countries, has issued guidance to take up the vaccination in pregnancy. It has been highlighted that the recommendation not to vaccinate in the early weeks of pregnancy was not due to concerns over risk, but rather worries that bleeding or miscarriage, of which there is a higher risk in the first trimester, could be mistakenly linked to the vaccine. Israel has a birth rate of 3.1 compared to 1.7 in the UK (and similar numbers in most Western countries) so they have a lot of pregnant women! No reports of additional concerns have emerged.
• In Australia and New Zealand the official guidance is “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”, so it appears they are going to wait and see what the evidence shows.
• The Canadian SOGC consensus statement reads: “Women who are pregnant or breastfeeding should be offered the vaccination at any time if they are eligible and no contraindications exist. This decision is based on the women’s personal values and an understanding that the risk of infection and/or morbidity from COVID-19 outweighs the theorized and undescribed risk of being vaccinated during pregnancy or while breastfeeding. Women should not be precluded from vaccination based on pregnancy status or breastfeeding.” Essentially the same as the UK and USA – definitely go along, but do have your questions answered.

Dr Piers Foster

GP

Coyne Medical