COVID-19 vaccine safety: thinking beyond the headlines

On 7 April 2021 the UK medicines and healthcare products regulator, the MHRA, confirmed that there may be a possible link between the COVID-19 AstraZeneca vaccine and specific types of blood clots. The MHRA’s statement followed the conclusions of the European Medicines Agency, the EMA, published a day earlier which advised that ‘unusual blood clots with low blood platelets should be lised as very rare side effects’ of the AstraZeneca vaccine.

Any statement about the possibly very serious, but also extremely rare, adverse side-effects of a potentially life-saving vaccine in the context of a global pandemic must be commented upon with extreme caution. The specifics of vaccine safety must remain the preserve of those with relevant expertise specifically clinicians and epidemiologists – and not lawyers.

With that caveat, there remain 3 broader takeaways from this week’s headlines that have so far received less attention in the mainstream media’s reporting on vaccine safety, and which from the perspective of a lawyer interested in product safety, deserve amplification.

The Importance of the MHRA’s Yellow Card System 

In the UK, a patient, a patient’s family or a clinician can report complications experienced with any drug or medical device directly to the MHRA, in real-time. It is the reporting of this data that has enabled the MHRA to step in this week, in the context of blood-clots, and provide more detailed guidance. Without details of adverse effects reported through the Yellow Card System, our regulator would have no direct or real-time way of understanding the complex picture on the ground in the context of the unprecedented population-wide roll-out of a novel vaccine.

The MHRA continuously publishes news updates and data collected through the Yellow Card system for both the AstraZeneca and the Pfizer vaccine. This data is publicly accessible[1] and for those anxious about experiencing complications or interested in the types of issues reported (from headaches, lethargy, through to blood clots) reviewing this data is recommended.

Importantly, the weekly reports are set in the context of the overall numbers of individuals who have received the vaccines and reported no complications whatsoever.

In a period of heightened anxiety, complex and sometimes erroneous media messaging around vaccine safety – going back to the data may provide reassurances for those of us still awaiting our invitations for vaccination.

The level of continuous scrutiny to which vaccine safety is subject internationally

There may be some questions about the speed with which the MHRA has made its most recent announcements concerning blood-clots, i.e. days after Ireland, the Netherlands and the publication of data by the EMA. Nevertheless, the MHRA’s intervention is rooted in the constant scrutiny of safety data, much of which is reported back through the Coronavirus Yellow Card system. Despite Brexit, and ongoing political tensions concerning vaccine supply contracts, the EMA and the MHRA are publishing similar statements concerning vaccine safety – drawing upon safety data reported across the EU as well as the UK. It suggests a degree of ongoing collaboration, which provides regulators with a much more extensive pool of safety data, and therefore the best chance of spotting early trends of potentially very serious, but also very rare complications.

The question of adequate support for the very few who suffer serious adverse effects directly because of vaccination

As expressed by Dr Raine, the MHRA Chief Executive, ‘no effective medicine or vaccine is without risk’. Contextualizing the very rare risk of potentially fatal blood clots vs the risk of experiencing life-threatening COVID-19 will likely lead many of us to go-ahead and receive the vaccination. However, as vaccination is made available to a different demographic, those under 30 for example, with less statistical risk of suffering serious complications of COVID-19, it is reasonable to suspect that concerns about adverse effects, no matter how rare, may play a part in increasing ‘vaccine hesitancy’. The headlines in the last few days have underscored the fact that moving towards ‘herd immunity’ is a national effort and that widespread vaccine confidence is a key part of that.

One way to achieve that confidence - besides the publication of transparent safety data as outlined in previous points - is to provide reassurances that if the worse thing does happen there is an effective compensation scheme.

As it stands, the Government’s plan for providing financial support for those suffering adverse effects is rooted in a statutory scheme: the Vaccine Damage Payment Scheme. Now more than 30 years old, as per many commentators, it is problematic in the way that it assesses eligibility for payments, and wholly inadequate to cope with the volume of applications set to increase in the course of an-all population vaccination program as the rest of the year unfolds.

Call for action

Back in December, we joined calls for the creation of a bespoke COVID-19 Redress Scheme, that will provide financial support for th very few of us who will suffer a blood-clot, or other potentially life-changing complications, causally linked to the vaccine. In the context of Yellow Card data published weekly by the MHRA, the recent headlines, and the vaccination of different demographics for whom the risks of hospitalization secondary to COVID-19 may be less acutely felt, reconsideration of the creation of a Bespoke COVID-19 Redress Scheme, fit for purpose, and capable of increasing vaccine confidence, has never been more urgent.



Other Perspectives