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Moderna reports that its COVID-19 vaccine shows nearly 95 per cent protection

Zahra Nanji discusses the latest COVID-19 vaccine news and argues that a compensation scheme should be regarded as an important component of a successful vaccination programme.

Coronavirus vaccine
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Zahra represents people who have been seriously injured and who have turned to her for her technical expertise and approachable manner. She has a special interest in complex and catastrophic injuries, including those caused by medical devices.
Hot on the heels of Pfizer’s announcement on 10 November 2020 that the early results of their COVID-19 vaccine candidate demonstrated that it is 90 per cent effective in protecting people from transmission of the COVID virus in global trials, today, US company Moderna report that their COVID vaccine shows nearly 95 per cent protection.
 
The Moderna trial involved 30,000 people with 50 per cent being given two doses of the vaccine, four weeks apart and the rest had dummy injections. There were 95 cases of COVID with only five of the COVID cases in people given the vaccine and 90 cases in those given the dummy treatment. The data also demonstrated that there were 11 cases of severe COVID in the trial, but no severe cases in people who were immunised with the trial drug.
 
Tal Zaks, the chief medical officer at Moderna, told a news source ‘"The overall effectiveness has been remarkable... it's a great day."
 
The potential efficacy of these trial vaccinations has surpassed all hope and expectations and is of course welcome news in light of a vaccine being the only likely avenue to a return to some level of normality. It is already known that globally, governments, including our own will look to expedite the roll out of the vaccine utilising it as primary measure to combat the COVID virus.

We do not know how long the effects of the vaccine will last for and we also have not had any reports on whether there are any long-term adverse effects caused by the vaccine. If adverse effects were to manifest, where would that leave the injured recipient of the vaccine?
 
At present manufacturers of both licensed and unlicensed products are protected from civil liability under the Human Medicines Regulations 2012, in the context of a pandemic, but pharmaceutical companies who place the product on the market are not expressly protected.
 
The government has recently proposed amendments to the regulations to provide civil immunity where things may go wrong to those responsible for an approved licensed or unlicensed product as part of the response to the public health immunity. The proposal is therefore to clarify legislation by putting pharmaceutical companies on the same footing as manufacturers, which means that those that develop, make and distribute (where they are separate) would all have protection.
 
The currently regulations does not provide complete immunity from civil liability as regulation 345(4) currently preserves the application of section 2 of the Consumer Protection Act 1987 (CPA). Regulation 345 provides immunity in relation to the use of the product in accordance with the licensing authority’s recommendation. Therefore immunity does not apply where the supply is materially inconsistent with the terms of the licensing authority’s approval.  There is also another defence to civil liability, where the producer is to be able to show that the objective state of scientific and technical knowledge at the time a product was put on the market, including the most advanced level of such knowledge, was not such as to enable that defect to be discovered at the time. 
 
What happens if there is no breach or a state of knowledge defence, but harm is caused simply due to the fact that we do not know enough about a vaccine? At what stage should a vaccine be pulled? Is it to be based on large numbers of people potentially having a small adverse effect or a small number who suffer a more serious harm?  Who would be responsible for putting things right? Currently, it is likely that immunity from civil liability or a defence of state of knowledge would apply, and there would be no recourse to civil compensation, although the Vaccine Damages Act (VDA) would apply.
 
The above means that there would be protection from civil liability for all of those in the manufacture and supply of these vaccines when things go wrong.  However, there is no counter-balance that if things go wrong, those receiving the vaccine have protection via a no-fault scheme. 
 
I consider that is unfair, unjust and it will undermine confidence in a vaccine where we ask an individual to take full unmitigated responsibility for the potentially serious effects of a vaccine where it has been rushed out. We of course welcome the vaccine and the extraordinary potential it has to help humanity escape from this pandemic, However, the basis of a vaccination programme is not just to take it to protect oneself but also the community and general public by preventing the spread of the disease. For this you need confidence in the outcomes of taking the vaccine to ensure there is uptake.
 
This does not mean that the roll out of the vaccine is not positive, of course it is.  The advances in science, working collaboratively and advancements in technology is incredible and has expedited the processes to allow a potential vaccine to be developed with such speed. 
 
However, as is the case with all medicines, inevitably there will be those that do suffer potentially severe and life changing adverse reactions. Without longitudinal studies, the only way in which people will have confidence to take part in a vaccination programme is knowing they will be ‘protected’ by the vaccine or protected should they suffer an adverse outcome. Without the confidence of the public, any vaccination programme may fail.
 
In these circumstances, it would be best to a no-fault compensation scheme that is reassuring to the public that they will be able to rely on receiving the help they need if things go wrong long term. For mass immunisation to work, there needs to be reliable safety net and alternative recourse to compensation if things go wrong.
 
We do have the Vaccine Damages Act, however, it pays out £120,000 as a maximum, which if someone suffers a very serious consequence, will be totally insufficient to help them, leaving the individual, their family, the NHS and the public purse to pick up the pieces.
 
I consider that a vaccine-injury compensation scheme should be regarded as an important component of successful vaccination programme and part of that is to ensure adequate funding.
 
There will of course be the question of who funds any scheme. We have to remember that there will be very significant profits made as a result of the roll of the vaccine, these companies are not charities but businesses. With such significant profits being made, consideration should be given to a levy being charge on companies selling the vaccines to the market.
 
This will still allow very substantial profits to be made, and it  will also prevent taxpayers and anyone adversely impacted by the vaccine should things go wrong in paying the ultimate price.  Long term  a no-fault system on both sides would provide the necessary confidence of all those involved from development to taking of the vaccine increasing significantly the success of any potential vaccination programme.
 
I consider that a no-fault scheme is one which should be considered very seriously, especially in light of the recent recommendations made in the recent report of Baroness Cumberlege ‘First Do no Harm’ published both in July 2020, which called for both a new independent Redress Agency for those harmed by medicines and medical devices to administer decisions using a non-adversarial process, with determinations based on avoidable harm, looking at systemic failings, rather than blaming individuals and for separate schemes to be set up for those suffering with the adverse impact of Sodium Valproate, Primados and pelvic mesh to meet the cost of providing additional care and support to those who have experienced avoidable harm being eligible to claim.

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