Understanding the Issues Relating to COVID-19 Vaccines and Pregnant Women

Recent press reports suggest that of all patients receiving life-saving COVID-19 care, unvaccinated pregnant women account for one in six cases.

These are worrying statistics, but it is also apparent that women are receiving conflicting and inconsistent advice from medical authorities and health care teams, so it’s perhaps no wonder that uptake of the vaccine is low among this group.

In an article published by Imperial College London (ICL), Dr Allyah Abbas-Hanif and Professor Neena Modi, from ICL’s School of Public Health, highlighted some of the issues relating to the subject.

Clinical opinion on the COVID-19 crisis and vaccinations for pregnant women

Dr Abbas-Hanif said that while most pregnant women who contract COVID-19, especially if they have received the vaccine, will only suffer a mild illness, it can, in some cases, lead to severe complications for both mum and baby.

From June to September this year, 13 pregnant women died of COVID-19 in the UK. Of these, 11 were not vaccinated.

Dr Abbas-Hanif acknowledged that, understandably, pregnant women have questions about vaccinations because they don’t want to endanger their babies. And, to add to their concerns, widely circulated false information about the COVID-19 jabs, including that they cause infertility and suspicions about the quick rollout of the vaccinations, has been compounded by conflicting information from authorities.

The default position, Dr Abbas-Hanif said, is to exclude pregnant women from drug trials and so there was no clinical information available for doctors when advising pregnant women about the COVID-19 vaccines. This enabled the conspiracy theories to take hold and the devastating effects are now becoming apparent.

Prof. Modi added that the lack of evidence relating to the vaccinations and pregnant women meant that the responsibility for making important decisions whether to have the jab was transferred from the pharmaceutical developers to women and their healthcare advisers. Without all the evidence to hand, this became a difficult task.

Is the vaccine safe for pregnant women?

Dr Abbas-Hanif noted eight clinical studies with a cohort of almost 80,000 pregnant women, and “real-world data” from 220,000 pregnant women vaccinated in the US and UK, which now show that the benefits of having the vaccination in pregnancy far outweigh the risks.

There has been no evidence that the vaccines increase risk of miscarriage, pre-term birth or birth defects and there is evidence that protective antibodies from the jabs are passed to babies through the womb and through breastfeeding.

Prof. Modi highlighted that the COVID-19 vaccines are not “live” and so it should have been reasonable to include pregnant women in the early clinical trials. However, as we now know that the risk of severe outcomes for pregnant women who contract COVID-19 is high, the time is right for the message to be made clear.

How will the COVID-19 vaccine development issues affect pregnant women in the future?

The ICL team agrees that pharmaceutical developers must work closely with regulators and pregnancy experts to consider the issues facing pregnant women as they develop medications, especially in circumstances such as a global health pandemic. They must do this in the same way they consider age, gender and ethnicity .

Dr Abbas-Hanif said that if the benefit outweighs risk, pregnant women should not be excluded from later-stage clinical trials.

The conclusion is that COVID-19 has altered how medicines can be developed and this is good, however, as academics, health authorities, regulators and industry partners work to accelerate the findings of critical research, pregnant women must not be left out of the equation. It is undeniably right that they should benefit from medical achievements and not be left exposed to greater risk.