The Vaccine to End the Pandemic? Next Steps, Licensing, and Freeing the Vaccine

Alexandra Zalokosta is a Greek third year Medicine student. She is passionate about climate justice, women’s issues and empowerment, and art in all forms. She strongly believes in the power of knowledge and political discourse. Currently Alexandra is serving as the Environmental Impact & Health Current Event Reporter of The Clandestine.

[Featured Image: A series of vaccine vials labelled “Vaccine COVID-19”. Source]

During the pandemic, public interest in medical research has, understandably, soared. As globally we become more and more aware of the fact that there will be no “going back to normal” until there is a vaccine, the race towards a licensed vaccine has been brought to the forefront of public awareness. Now more than ever, people have become interested in the workings of pharmaceutical research – how trials work, what approval will mean, how long will it take. However, the spotlight on healthcare has also exposed the socioeconomic inequalities that have existed in the field, with increasingly more people around the world calling for universal a “people’s vaccine”. In this article I will be attempting to answer some of the questions surrounding where we go from here. How does research transition into licensing and finally distribution? What will the process of approval be? Why have “people’s vaccine” and “Open COVID Pledge” movements emerged and what exactly do these terms mean?

Currently, it seems that the first vaccine set to be released, if all goes well, is the Oxford vaccine. This vaccine, along with eight others is in the final stage of clinical trials, Phase 3. In order to fully understand what exactly that means, one has to go over what the basic stages of trials for medications, starting after literature reviews and theoretical development, all the way to approval. The first trials that occur are the preclinical trials of laboratory testing, also known as Phase 0. These involve microscopic analysis of the action of the medication, and testing on animals such as mice. If these trials show a significant desired effect, in this case evidence of an immune response, clinical trials begin. These occur in three phases and involve human participants. Phase I is concerned with safety, involving a small group of healthy individuals. Phase II is expanded, involving hundreds of participants, and includes various groups of people to see if they react differently. In Phase III, the vaccine is distributed to thousands of people, and involves placebo groups as well as groups receiving different doses.[1]  [2]

Having understood the scientific perspective of pharmaceutical research, the question is: What will happen next? Approval of any vaccine will involve not only scientific analysis, but also governmental licensing. In the UK, if Phase III is proven successful a vaccine then moves on to licensing. At this stage, an expert review of all data from the trials is performed by the Medicines and Healthcare products Regulatory Agency (MHRA) or the European Medicines Agency (EMA). Regulators check that the vaccine meets efficacy and safety levels, and that its advantages for the general population outweigh any disadvantages that may have been discovered. After licensing has moved forward, Phase IV studies will continue taking place, monitoring any effects of the vaccine as it rolls out to the general population.2 Until December 31st, while the Brexit transition period is ongoing, the UK still falls under the authority of the EMA. However, the UK government have made a decision that if a vaccine were to seek approval during that period, licensing will happen under the MHRA, as health officials have set up plans to fast-track temporary approval by the MHRA, to allow for rollout with appropriate safety measures while official licensing is ongoing.[3]

In preparation for rollout, the UK has already made deals with multiple companies and has secured options for 340 million doses.[4] With a population of 66.65 million, the UK are part of a trend showing the richest countries, which represent about 13% of the global population, having bought 51% of the doses of the five most promising vaccines. Highlighting this inequality is the comparison between the UK and Bangladesh. While the UK have secured the equivalent of about five doses per person, Oxfam report that Bangladesh have managed to secure one dose for every nine people. And with these numbers it is important to keep in mind that it is unlikely that all five vaccines will be successful, but even if they are, 61% of the world’s population will not have access to any potential vaccine until at least 2022. Furthermore, it is important to consider the sheer number of the global population as an aspect of this inequality. While the pharmaceutical company Moderna have, as of now, only pledged doses to rich countries, another company, AstraZeneca have pledged two-thirds of their doses to developing countries. But even with this pledge and Astra Zeneca taking steps to expand production, their vaccine could still only supply 38% of the global population, and only half of that if it is shown to require to doses.

Lastly, one distinctly non-scientific aspect of the vaccine process, which is also one surrounded by controversy. Any pharmaceutical company that does discover a vaccine will hold the patent to what has now arguably become the most valuable product on the planet. The debate between intellectual property rights and universal access to medicines has been ongoing for decades, but its urgency and importance have become more apparent than ever due to the pandemic. Specifically, even though billions have already been made in deals between countries and pharmaceutical companies, concerns still remain that the vaccines will still be sold for profit when they enter the market, and with most of the promised doses being bought by the richest countries, the majority of the global population will not have access to any vaccine until long after it has been approved.[5]

This has led to the United Nations and Oxfam among other international organisations to call for a people’s vaccine, a vaccine that will not be sold for profit and will be accessible to all.[6] Furthermore, the WHO has expressed the possibility of a patent pool for any potential products relating to the pandemic to allow for open licensing and worldwide production and distribution – however, the executives of many large companies have dismissed the possibility of participating in such a scheme, with the chief executive of Pfizer, one of the pharmaceutical companies currently working on a vaccine, calling it “nonsense” and “dangerous” with relation to the large economic risks being taken by the companies.[7] Associated with the intellectual property debate is the movement for an Open COVID Pledge, a call for organisations to pledge to share their intellectual property in the fight against COVID-19.[8]  Finally, related to campaigns concerned with equitable access to COVID products is a student-led initiative called Universities Allied for Essential Medicines, an international organisation that has existed since 2001.[9] One of their goals has been to campaign within universities and work with university licensing officers to apply Equitable Technology Access Framework.[10] This is a new initiative designed by UAEM that includes more socially responsible licensing policies. UAEM UK has grown a lot this year, with many new chapters, including one at KCL, with a primary focus on COVID and freeing the vaccine, as well as running courses to educate students.

The topic of pharmaceutical research is a complicated and seemingly dry one, hence why it has never been in the international spotlight before. However, this year has showcased that we are extremely dependent upon this industry, both on personal and global levels. Thus, it is important to become informed, and my hope is that this article has helped in making some information about what comes next a little less daunting .











One Comment Add yours

Leave a Reply