By Alice Taylor
9th October 2020 (updated 13th November 2020)
Hello! I’m Katey’s cousin Alice and I’ve spent 10 years working in the clinical trials industry. As you can imagine, over the past few months I’ve been following the news of coronavirus vaccine development closely, both from a personal and professional point of view. More recently, I’ve also seen alarming claims about the rollout of a coronavirus vaccine go viral on social media and am concerned that these claims may harm efforts to stop the spread of COVID-19.
I’ve written this article to explain more about the changes the UK government are proposing to make to existing vaccine legislation, and how these changes would apply to a coronavirus vaccine specifically, to try and combat misinformation.
To clarify, the organisation I work for now doesn’t have a potential coronavirus vaccine in development.
What is a vaccine?
A vaccine is a type of drug which is designed to prevent someone from getting a disease, rather than treating a disease once someone has already caught it. Vaccines work by teaching the immune system to fight against a weakened version of a disease, which is unable to cause the disease itself. This means that if the actual disease ever shows up in the body, the immune system will recognise it and can defeat it quickly before it causes any problems. Watch this video for more information.
The World Health Organisation estimates that vaccines prevent 2 – 3 million deaths globally each year from diseases like diptheria, tetanus and pertussis.
How is the UK government proposing to change the law with regards to a coronavirus vaccine?
The British government published a consultation paper on the 28th August 2020, which lists changes they are proposing to make to the Human Medicines Regulations 2012. This law governs the licensing, manufacture, wholesale dealing and sale or supply of medicines for human use. The consultation paper was addressed to key people and organisations with specialist knowledge of public health and the existing law, although anyone was welcome to comment on it.
The 2012 Regulations already state that exemptions to certain aspects of this law can be made for medicines used to treat a pandemic disease, like COVID-19. However, the law doesn’t currently allow any exemptions for medicines used to prevent pandemic disease, so a coronavirus vaccine would not be covered by the existing legislation. As the government believes an effective COVID-19 vaccine will be the best way to deal with the pandemic, they are proposing to change the law in several ways to make widespread rollout as easy as possible.
Frequently Asked Questions
Here are some Frequently Asked Questions about the proposal, based on comments I have seen on social media. Note, these questions and answers only cover this particular proposal – I haven’t tried to predict any further changes the UK government may consider, or how other countries may choose to roll out a vaccine.
If the coronavirus vaccine is unlicensed, does that mean it hasn’t been tested?
No, ‘unlicensed’ doesn’t mean ‘untested’. All drugs in the UK have to go through three phases of clinical trial testing to prove the drug is safe and effective before they can be rolled out more widely, and this is true of every potential coronavirus vaccine too. There are currently over 40 different coronavirus vaccines being developed by scientists all over the world, in various stages of the testing process.
It usually takes a really long time, sometimes up to 10 years, for all three clinical trial phases to be completed. As the COVID-19 pandemic is an urgent, global threat, the testing process is being sped up by overlapping some of these phases. (Check out a really useful diagram which illustrates this here.) This is a much more difficult and expensive way of conducting clinical trials, which is why this isn’t the normal process. Although the trial phases for potential coronavirus vaccines are being accelerated, in the UK the testing itself within each phase is no less strict than it would be under normal circumstances. At each phase, if there isn’t enough data to show a coronavirus vaccine is sufficiently safe or effective to move on to the next phase, that vaccine will be abandoned.
Licensing is the stage that takes place after these three trial phases have been completed, where the licensing authority (the Medicines and Healthcare Products Regulatory Agency [MHRA] in the UK) reviews all the trial data. It then decides whether the drug should be granted a license, and what patient population, disease indication and dosage that license covers. If a safe and effective coronavirus vaccine is available, as proven by clinical trial data, the manufacturer will still have to apply for a license from the MHRA. However, given the circumstances, the Joint Committee on Vaccination and Immunisation (who advises UK health departments on immunisation) will advise the UK government to proceed with coronavirus vaccine rollout before a license has been granted if they believe there is strong enough evidence to do so.
Could I sue the drug company or the person administering the coronavirus vaccine if I had a bad reaction after receiving it?
Generally speaking, no. The law already protects drug manufacturers from being sued in the civil courts when the licensing authority recommends that an unlicensed product is used in response to a public health threat. The government is proposing to expand this legal protection slightly to include drug companies who want to put an unlicensed product on the market, where that drug company is not the manufacturer of the drug – as is the case with several of the potential coronavirus vaccines, which are being developed by universities rather than drug companies.
You couldn’t sue the person administering the vaccine either. The law already protects people administering licensed vaccines from being sued, on the understanding that it isn’t their fault if someone has a bad reaction after vaccination (provided they administered the vaccine correctly). The government wants to amend this part of the law to include people administering unlicensed vaccines too, for the same reason.
You could still sue the drug company if the vaccine is defective, with defective defined as not as safe as you are entitled to expect. Likewise, you could still sue the person who gave you the vaccine if you could prove it was administered incorrectly.
Could I claim compensation from the government if I had a bad reaction after receiving the coronavirus vaccine?
This isn’t yet clear. The government does currently operate a compensation scheme called the Vaccine Damage Payment for people who are severely disabled as a result of vaccination. Individuals are only eligible for this payment, given as a one-off tax-free sum of up to £120,000, if their severe disability was caused by vaccination against certain specific diseases. The government hasn’t yet clarified if coronavirus will be added to this list of diseases.
Will the people administering the coronavirus vaccine be unqualified or non-medical?
No, the people administering the vaccine will be qualified. Given the huge number of people who would have to be vaccinated in as short a timeframe as possible, the government wants to amend the law to allow healthcare professionals who do not normally vaccinate, e.g. midwifes, physiotherapists and paramedics, to be able to administer a coronavirus vaccine. The group of people allowed to administer a coronavirus vaccine may be expanded further to also include those who are not registered healthcare professionals. In all cases, there would be a detailed protocol to follow to ensure all of these people are appropriately trained via an NHS approved training programme before they may start vaccinating.
The people administering the coronavirus vaccine most likely will be non-medical – just as they are now when it comes to other vaccines. ‘Non-medical’ means anyone except doctors or dentists, so that includes pharmacists and nurses, who administer most vaccines like the flu jab already.
Will the coronavirus vaccine be mandatory or mass promoted?
No, the proposed changes to the law do not include plans to make a coronavirus vaccine, or any vaccine, mandatory in the UK.
The government is planning mass promotion of the coronavirus vaccine in a similar way to how they promote the flu vaccine. It is already legal for vaccination campaigns to be advertised to the public, but the vaccines in these campaigns currently have to be licensed. The proposed changes would allow the promotion of an unlicensed, temporarily authorised COVID-19 vaccine.
Will the coronavirus vaccine be 100% safe?
No, no vaccine is 100% safe. The underlying principle behind a coronavirus vaccine, same as any other vaccine, will be that vaccinating is safer than not vaccinating. People can and do suffer bad reactions from vaccines and this is unquestionably terrible for those affected. However, this is a very, very small proportion of the total number of people who receive vaccines, the vast majority of whom experience no significant side effects. Given the potentially fatal consequences of COVID-19 – as well as serious long-term effects aka ‘long covid’ – and provided that there is very robust scientific evidence to support it, the government would deem the benefits of taking a coronavirus vaccine to far outweigh the risks. It is up to individuals to decide if they agree.
Update: Consultation Outcome (added 13-Nov-20)
The government published the outcome to their public consultation on proposed changes to the Human Medicines Regulations on the 16th October. Based on the 191,740 responses received, the government will go ahead with drafting legislation to amend the existing law as they had outlined, and as summarised above, with 3 key changes:
1. Attaching conditions to a temporarily authorised vaccine
The consultation outcome emphasises that although the existing law contains a provision that enables the temporary authorisation of an unlicensed medicine in response to a public health emergency, this provision should only be used in truly exceptional circumstances. The decision to use this provision will only be used at the request of the Secretary of State for Health and Social Care, if the MHRA advises that there is robust evidence to demonstrate that the vaccine is sufficiently safe and effective. The government has amended the proposed changes to say that a review must be done within a year of the first use of this provision in order to evaluate the whole process, but they note that they expect any temporary authorisation to be short-term anyway as it would cease as soon as a full license is granted.
2. Extending immunity from civil liability
Many people responding to the consultation were concerned that pharmaceutical companies would not be held accountable for any problems with the vaccine (e.g. serious side effects). The consultation outcome explains that the existing law already recognises that it is unreasonable to ask drug companies to take on the liability for consequences of the government’s decision to authorise the supply of an unlicensed drug. However, the outcome stresses that you would still be able to sue the drug company who make the vaccine in the event of a ‘sufficiently serious breach’ of the approval conditions set by the government. Where the original consultation proposed that the courts would judge the seriousness of any breaches of the approval conditions from the perspective of a pharmaceutical company, the outcome states that the courts must instead make this judgement from the point of view of a person who has ‘relevant expertise in the subject matter of the breach’.
3. Expansion of the workforce
The consultation outcome makes it clear that new vaccinators must undergo comprehensive training and pass a competency assessment, under the clinical supervision of a healthcare professional, before they can administer vaccines to patients. Based on the consultation feedback, the government has added a requirement for new vaccinators to receive continued supervision by an experienced vaccinator, where appropriate, once this training is complete.
The outcome also clarifies that vaccinators must obtain informed consent from each person receiving the coronavirus vaccine before it is administered, as is standard practice now for all other vaccines or indeed any kind of medical treatment, test or examination. This underlines that the coronavirus vaccine will not be mandatory – it will only be administered to people who voluntarily consent to receive it, after they have been fully informed of all potential benefits and risks.
Vaccine Information Resources
If you’re looking for further information on vaccines and the coronavirus vaccine in particular, try the following links:
- The Oxford University Vaccine Knowledge Project – an excellent resource recommended by the NHS for all kinds of clear, general information about vaccines, with detail on those which make up the UK immunisation schedule.
- Full Fact: Coronavirus Treatment – Full Fact is a charity based in the UK which addresses a wide range of viral misinformation. Their expansive coronavirus coverage includes responses to claims that RNA vaccines change your DNA, and that Bill Gates is planning to put microchips in COVID-19 vaccines.
- Johns Hopkins University Coronavirus Resource Center: Vaccines FAQ – Johns Hopkins University in the US has been a brilliant source of coronavirus information from the start of the pandemic. Some common questions about the coronavirus vaccine are answered here, while elsewhere on their vaccines hub they go into detail about COVID-19 vaccine trial design, regulatory integrity of vaccine studies and more.
- CDC: Busting Myths and Misconceptions about COVID-19 Vaccination – a short but useful piece from the American Centers for Disease Control tackling common COVID-19 vaccine myths.
- WHO: Coronavirus Disease (COVID-19) Advice for the Public: Mythbusters – a very handy page that pools together a large number of myths about the coronavirus, including the claim that vaccines against pneumonia offer protection against the coronavirus.
I’ve found it a lot harder than I thought it would be to find good resources debunking coronavirus vaccine myths specifically, so I’m not surprised that misinformation about it has been able to spread and take hold among the general public so stubbornly. Speculation, unconfirmed reports and outright lies have filled the hole where reliable information should be. Experts are well aware of this issue and know that it’s essential that it’s dealt with in order for the vaccine to be rolled out successfully. Now the first effective coronavirus vaccine is on the horizon (albeit with many questions still to be answered), hopefully a comprehensive, nationwide myth-busting campaign will follow shortly. In the meantime, if you do see or read something alarming about the coronavirus vaccine, remember to follow advice on how to spot misinformation before you get tricked into believing (and worse, sharing) something untrue.
More from What’s on Watson’s Plate:
- Article: Practical Tips to Reduce Risk from Coronavirus
- Article: Probably ‘That’ Coronavirus: My Symptoms
- Article: Carbs: The Good, the Bad and the Sometimes ‘Farty’!
- Health Diary Week 0: Food, Exercise and a Positive Mind: The Starting Point
- About Me: What’s on Watson’s Plate