Trust in the regulation of the Covid vaccine may matter as much as trust in the science behind it

Earning trust not just in the safety and efficiency of Covid vaccines themselves, but in the regulatory approvals process may be important in combating growing vaccine hesitancy. Citizens need to feel confident that the greater public good, not political expediency or commercial gain is the driver of regulatory decision-making.

Faith in vaccines has fallen everywhere except China according to Ipsos-Mori September 2020 poll. A critical factor is the growing worry among citizens that the approval processes is being driven by politics rather than science. Attempts by China and Russia to bypass Phase 3 trials brought disquiet, but the trend is most noticeable in the US, fuelled by media coverage of ex-President Donald Trump’s attempts to fast-track a vaccine for electoral advantage. In this context 83% said “they would worry about the safety of a vaccine if it was approved quickly.” A cause for concern given that all Covid vaccines will be approved quickly compared to the usual timescale.

In an unusual step, the leading vaccine manufacturers hoped to bolster public confidence by committing to a Covid-19 Vaccine Maker Pledge in which they agreed only to submit vaccines for approval after demonstrating safety and efficacy through a Phase 3 clinical trial. Regulators themselves have been characteristically quiet. This will need to change.

So what do regulators need to do to help earn societal trust in the integrity and effectiveness of their approval processes? The findings of our research into Trust and Technology Governance may provide some helpful pointers. In the memorable words of Baroness Onora O’Neill, we conclude the best approach to earning trust is to ‘first be trustworthy and second provide good evidence of your trustworthiness’.

Ensure public good focus and fairness & integrity of process

Being perceived as trustworthy is likely to hinge on regulators clearly demonstrating their focus on the public good, the fairness and integrity of their processes and total independence of vested interests in their decision making. This approach is supported by citizens in research indicating they are much more likely to trust governance and regulation when they can see it in action, standing up to attempts at subversion and focused on the public good.

But demonstrating you are trustworthy doesn’t mean trying to achieve consensus of avoid conflict. Whatever decisions are made there will be disagreements. Many who believe the growing death toll and economic fall out merits a less precautionary approach may consider the process too slow. Others more concerned about hidden risks or unintended side effects may consider it too quick. These opinions will be the focus of intense media and social media debate, and regulators will have to step out of their comfort zone and take a much high profile in this debate.

Step into the spotlight — with openness and honesty

In such a highly charged situation a radical openness and honesty may help reach beyond the barriers of partisan lines and pre-existing views about vaccines, government competence and covid strategy. Starting with the basics, simply knowing which regulatory agency is responsible and which individual is in charge and is accountable for the decisions will matter. (82% of people in the UK felt more protected when they had heard of a regulator).

Listen to what concerns us — and address that

Instead of just being in broadcast mode, regulators will help themselves by listening closely to what concerns us and use their voice to help address those concerns.

Be more human — get out and help us understand how it all works

Citizens in research say they want regulators to be more human, help them understand what it is they do and how it works. Meaning the decision-making process itself and individual decisions will need to be explained in plain language everyone can understand. Preferably with good infographics, videos and respectful, unpatronising communication.

Get out into the community — enable citizens to ask the direct questions that concern us. Hold public events, reach out through media and social media.

Hurray for the European Medicines Agency who have a good website and seem to be taking the lead, and are holding a public meeting on Dec 11th to explain ‘the EU regulatory processes for the approval of COVID-19 vaccines and the Agency’s role in their development, evaluation, approval and safety monitoring.” FDA have some helpful information on their website. UK MHRA seems spectacularly dull and unhelpful, though UK until Brexit falls under the EMA, they could be doing so much more than appears to be the case.

Dealing with this sort of scrutiny does not come naturally to regulators. But the willingness of many citizens to be vaccinated may be much improved by their providing this evidence of their trustworthiness with clarity and empathy. After all, learning by doing is the new normal.

Hilary Sutcliffe is co-Director of TIGTech and not-for-profit SocietyInside

Download the report on Trust and Tech Governance at www.tigtech.org

The Report will be launched in the UK on Friday Dec 11th at 2pm GMT. All welcome — register here