Allie Renison: Pregnant and breastfeeding women deserve choice over whether they have the Coronavirus vaccine

22 Dec

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.

Allie Renison: Sunak wants to link funding to viability. He’s right – but he must help to keep firms viable in the first place.

9 Oct

Allie Renison is Head of Trade and EU Policy at the Institute of Directors.

Emergency government intervention in the market should in principle seek to target endeavours that have fundamental viability – of that, most are agreed.

At the start of the crisis, this principle was rightly balanced against the need to get money out the door quick – every day of delay would have meant jobs lost. As the pandemic has worn on, it was inevitable that the idea of tying support to viability would come into sharper focus. But while the Chancellor is right to tack towards this principle, we need to make sure we are on same page as to what viability means in the current context.

We should not forget the central role the state is playing in curtailing the normal functioning of industries across the piece. From changing advice on working from home to the omnipresent one to two metre social distancing rules, a significant share of the UK economy is currently rendered far less sustainable than it would be in the absence of these changes. This is not about apportioning blame, but raising the longer-term future of the measures underpinning them.

If the rules and guidance are to shift to relax social distancing restrictions, then it is perfectly reasonable to question the viability of business thereafter. If the message is that these constraints are the permanent or long-term parameters through which we should gauge sustainability, then that message needs to be loud and clear. Either way, the basis on which fiscal and non-fiscal support is given to viable businesses should reflect the extent and horizons of government restrictions. As they change, so too should the flexibility and scope of assistance.

In Rishi Sunak’s endeavour to ensure the Government still carries out its “sacred responsibility to balance the books”, he shouldn’t overlook the part that supporting business will have for the economic recovery. Longer-term viability should not be sweepingly sacrificed at the altar of picking losers in the shorter term.

Alongside grappling with this issue of viability, the Chancellor should set out broad-based measures to give UK plc the shot in the arm it needs – particularly as many SMEs have fallen through the cracks of the initial support schemes. Options for these broadly fall into three categories of focus – protecting and creating jobs, supporting adjustment, and spurring investment. While the Treasury may be mulling tax rises in future, the immediate focus should be on minimising the burden on business for the here and now.

Encouraging firms to retain, (re)train and hire workers in the current climate as the furlough scheme winds down and restrictions continue is undoubtedly a challenge. Of the third of IoD members who still had staff on furlough in September, 60 per cent expected to be able to retain three quarters or more of their workers.

For some businesses, Sunak’s new top-up plans will be enough; but plenty of SMEs at the smaller end will find the price of keeping staff too much. Lowering the adapted Job Support Scheme’s employer contribution for non-worked hours could help in this regard, potentially being funded by removing the job retention bonus (less than one in five directors who had furloughed staff said the bonus would help them retain their employees).

Bold action to help as many firms possible not only hold onto but also create jobs is needed – and cutting the cost of employment is the right place to start. Reducing the burden of Employer NICs, either by boosting the Employment Allowance for smaller firms or lifting the threshold for payments, is one of the top three potential confidence-boosting measures among IoD members.

It is a two-for-one that would both support hiring and provide a one-off cash flow boost to business. Meanwhile, providing new tax incentives to help company investment in training – particularly lifelong learning – would also drive the adult re-skilling needed as firms move towards automation and new digital processes to drive productivity.

Facilitating adjustment will be critical to business confidence as the pandemic evolves – whether that’s returning to normal in a safe way, or exploring a new way of doing things.

Many of our members have said that the reason for their reduced office use was that working from home was proving more effective; expanding the scope of R&D tax credits could be an important tool to help more small firms maximise on the potential productivity gains. Tellingly, investment in digital infrastructure ranked as the top director priority for government to prioritise for spurring an economic recovery.

Lifelines such as government-backed loan schemes and tax deferrals are also crucial measures to extend in helping viable companies continue to weather the storm. Expanding local authorities’ discretionary grant finding will also help for a more appropriately targeted response to help temporarily impacted firms and sectors adjust to localised lockdowns.

And finally, it’s important that measures target the regulatory side too. While the Government has extended some emergency insolvency relief provisions, it needs to do the same for suspension of ‘wrongful trading’ liability to allow firms to seek and access finance during the pandemic.

With new figures out from the IoD showing that the business investment outlook stalled in September after a significant rebound over the summer, it’s vital for the Government to bring forward plans to give industry a boost. In addition to broad-based tax reliefs to harness digital and adaptation technologies, the annual investment allowance cap should be extended beyond 2020.

Additionally, to support growth, a business rates holiday could be introduced on the additional charges firms face when improving or expanding or moving into commercial property. Meanwhile, to turbocharge entrepreneurial growth at a time it is desperately needed, the Treasury should ease restrictions for investing in start-ups and scale-ups by making schemes such as EIS and SEIS more accessible.

Business leaders know that tax incentives at a time of already increased public expenditure to support jobs and enterprise will eventually need to be paid for, but taking action now to stimulate the economic recovery will help lessen and spread the overall burden.

Enabling firms to adjust to a changing landscape of restrictions will help protect jobs, while facilitating business investment will help create new ones. It is this interconnection of priorities the Chancellor must now address and ensure business taxation goes in a productive, efficient direction to support viability, before he can start to focus on balancing the books.