Allie Renison is Head of Trade and EU Policy at the Institute of Directors. She writes in a personal capacity.
Choice. It’s often what divides the world view of Right from Left, or at least is what the former tends to identify its ideological principles around in differentiating itself. But there are some areas of government intervention where there should be no distinction, and the administration of vaccines to fight the current Coronavirus pandemic is one of them.
Sadly, for all the rush to claim glory in being first to authorise for emergency use, the UK is falling far short in equality of access to those who need it. The MHRA has decided to advise against pregnant and breastfeeding receiving the Pfizer vaccine, and in a universal public healthcare setting which is tightly controlled, that means they will not be able to access it.
The argument goes that as these cohorts were excluded from clinical trials, the minimal theoretical risk is irrelevant without sufficient data. Pregnant and lactating women have often long been excluded from such trials on safety grounds, and it is an exclusion which brings its own risks and delays to innovation and medical research development writ large.
But in a pandemic setting, we are in acute danger of missing the bigger picture. Namely, that the risk and severity of Covid – particularly for this patient group – outweighs the theoretical unproven risk of the vaccine. And while there is a role for caution in giving medication to women in this group, it is essential to remember the specific and inherently low-risk nature of these kinds of vaccines.
While they are not extensive, studies conducted so far paint an alarming picture, and one where precautionary red tape for its own sake should not be the chief determinant. In the US, a CDC report from earlier this year found pregnant women with Covid-19 (particularly in the third trimester) were three times more likely to require ICU admission and that their risk of death is 70 per cent higher than those who are not pregnant, and that is before adjusting for other demographic variables and comorbidities. This should hardly be surprising; pregnancy itself is considered high risk for developing severe diseases.
Compounding this is the fact that those at risk, particularly from minority ethnic backgrounds, are often much more likely to work in healthcare, so it’s not hard to see a ticking time bomb. Only, with a vaccine now not only on the horizon but in place, this is one time bomb that has no reason to go off – certainly not without women having a choice in the matter. It is likely for this reason that regulators in both Canada and the US have allowed that choice to proceed and left it up to them to decide.*
In the UK by contrast, it appears the precautionary approach endures well beyond the EU and Brexit. Beyond women having had to suffer through births and miscarriages alike alone, with bans on partner accompaniment, they now face an agonising set of choices in the absence of being able to access the Pfizer vaccine, even if in a higher risk category. Breastfeeding mothers in particular will have to weigh up feeding their children naturally or being inoculated against the virus. For medical professionals, it is even worse – many openly say the choice is between lying about their condition (unthinkable) or carry on treating patients without being able to protect themselves.
The NHS and government websites don’t even try to sugarcoat it, calling this an explicitly precautionary approach: “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”. The unconscionable position this in particular puts many healthcare workers confounds neonatal experts up and down the country. Ultimately, the severity of this disease surely has to outweigh theoretical risks to its cure, and surely women should have a choice in making that decision.
After all, as many point out, the ingredients in the Pfizer vaccine themselves have all previously been found safe for them to use. The Hospital Infant Feeding Network and many other advocacy bodies for healthcare professionals – the subject matter experts, we should remember – say this is putting these women in a discriminatory position, and are calling on the MHRA to amend its guidance to follow the US FDA’s approach and urgently commit to collecting more patient data. Studies in pregnancy are to be prioritised but no such plans have yet been made for women who are breastfeeding. Public Health England would be failing in its duties for this approach to carry on.
Beyond this, the narrative which authorities claim to be concerned about with respect to combating anti-vaccine sentiment, will continue to spiral for as long as this restriction remains in place. No one will care that this is simply a precautionary rather than evidence-based approach. It provides the confirmation bias many want, and it will be – indeed is already being – exploited. Hundreds of breastfeeding doctors alone are on hand, willing to be vaccinated and give their breastmilk for research, yet days continue to pass without any take up.
Personally, as a woman of childbearing age, I find it downright terrifying, infuriating and more than a touch paternalistic that this kind of choice could be kept from me. More safety data is absolutely needed as we go, but the inability to make that decision myself leaves me with no agency over my own body. Knowing the state is withholding that control, not to mention from those caring for Covid patients and with higher risk profiles, leaves me feeling I live in a thoroughly socialist country, not one where risk and choice are balanced against one another.
Ultimately, big picture thinking simply must come before process. After all, it is for this reason that emergency use authorisations were put in place for vaccines to begin with – the wider risks to public health have to come first. If there is one case to plead for women’s rights being more than just a passing fad, it is this.
No one should have to forego access to lifesaving drugs because of their biology. This is why many in the neonatal healthcare community have banded together to petition authorities in the UK to reassess vaccine eligibility. Action is not only needed in the short term but also in the long haul, which is why experts are urging a “presumption of inclusion” for all future clinical vaccine studies.
And lest anyone think feminists incapable of compromise, we can at least make the call for female workers on the front line to benefit from some choice here. Stop putting them in impossible positions which constrain their ability to fight the pandemic effectively. Amend the guidance for medical professionals and move to gather additional evidence needed. Listen to the subject matter experts. Take heed from other countries. And above all, trust women to make informed choices about the risks to their own bodies.
*Noon update: The EU has advised that the assessment whether to provide a vaccine to a pregnant woman should be done on a case by case basis.