For many years ahead, 2020 will be a reminder of the beginning of the coronavirus pandemic that created global chaos, affecting everyone’s life either directly or indirectly. The unforeseen transnational spread of the virus has resulted in over 29.6 million cases worldwide and 938,000+ deaths in a very short time span. As fear for the second wave continue, the British government has proposed changes to the Human Medicine Regulation (HMR) in-order to permit temporary authorisation and rollout of unlicensed vaccines in a mass vaccination effort in response to the public health threat – COVID-19, if one was to become available before the end of 2020.
The Human Medicine Regulation 2012 sets out a regime for the process of authorisation of medicinal product, with the European Medicines Agency playing a central role in licensing all medicine used in the European Union after careful and in-depth examination of clinical trial results. After Brexit (January 2021) the UK’s licensing authorities, Medicines and Healthcare products Regulatory Agency (MHRA) and Executive Agency of the Department of Health and Social Care will have new power to authorise all new medicine and vaccines. However, until then the government has called upon the Joint Committee on Vaccination and Immunisation (JCVI) to advise them on potentially using a tested but unlicensed vaccine against COVID-19 if one was showing promising results.
“On public health grounds, if a vaccine becomes available that isn’t yet licensed… and is shown to meet the expected high standards of safety, quality and efficacy… then the JCVI might take steps to advise the vaccine”.
Consultation document: changes to Human Medicine Regulations to support the rollout of COVID-19 vaccines (2020)
When looking roughly at how long vaccines take to be manufactured, clinically tested and licensed it’s important to understand that it takes time, rigorous clinical testing, data gathering and evaluation. Clinical testing alone consists of three different phases. Phase I involves testing on a small number of human adults to ensure that there is no safety concern with the product and to figure out an effective dosage. Phase II involves hundreds of people in an attempt to check consistency and to start picking out possible side effects. Lastly, Phase III involves thousands as the drug is randomised and placed against a placebo to ensure its safety and efficacy. The development of a vaccine is a long and complex process which can take between 6-15 years. Hence, this poses a question whether the UK governments choice to temporarily authorise an unlicensed vaccine, if one was to become available, within the short time period that the pandemic has been occurring is the right choice.
The belief that the government is trying to “take the right measures at the right time” is largely overshadowed by not only the quick time frame the vaccine is trying to be developed in, but the unknown risk attached to the approval and roll out to the public. By now, we have all seen and experienced what I call the Boris paradox, the constant changing of opinion and action from ‘do this’ to ‘don’t do this’. Therefore, it’s hard to deduct whether this idea of ‘taking the right measure’ is the correct thing to do to ensure public safety, or whether it’s just another call the government is willing to make in this uncertain time to meet the increasing pressure faced by the public and the pandemic.
Furthermore, the proposed change in the HMR is also associated with providing immunity from civil liability to non-health care professionals, in an attempt to increase the workforce needed for mass vaccination. Despite this workforce being professionally trained in assisting the COVID-19 vaccination programme, the idea of immunity from civil liability is dangerous. If an issue of misconduct or error in procedure occurs – which can have detrimental effects on the public – there will not be a structure in place to file for justice for the wrongdoing. This can lead to human rights issues of lack of informed consent.
Lastly, the proposal also informs us of the use of advertising to promote the unlicensed vaccine. It’s important to acknowledge that currently, the advertisement of unlicensed medicine to the public is prohibited. This change is in danger of resembling propaganda use, a strategy to get people vaccinated and enact in a way that the government believes would be the best way to reduce the risk of the public health threat. Not only does the use of advertising involve the communication of claims of efficacy, but proposes a false known, certainty of success, which at this early stage is unknown and probably won’t be for a few more years to come.
As this article has attempted to communicate, the UK government is trying to act quickly in this unprecedented time of COVID-19. Even though its aims to protect the public are of good nature, it does not mean that all of their actions have the best intention for the whole demographic.
Written by Patrycja Talaga.
Alliance for Natural Health International (2020) UK Law Changes For COVID-19 Mass Vaccination. [online] Available at: https://www.anhinternational.org/news/uk-law-changes-for-covid-19-mass-vaccination/
GAO, 2020. Traditional Timeline. [image] Available at: <https://www.gao.gov/products/GAO-20-583SP#summary> [Accessed 30 September 2020].
GOV.UK (2020) Consultation Document: Changes To Human Medicine Regulations To Support The Rollout Of COVID-19 Vaccines. [online] Available at: https://www.gov.uk/government/consultations/distributing-vaccines-and-treatments-for-covid-19-and-flu/consultation-document-changes-to-human-medicine-regulations-to-support-the-rollout-of-covid-19-vaccines
History of Vaccines (2018) Vaccine Development, Testing, And Regulation | History Of Vaccines. [online] Available at: https://www.historyofvaccines.org/content/articles/vaccine-development-testing-and-regulation