Vaccine talk: Therapeutic development or a political game?
While the world is facing a second wave of the COVID-19 pandemic, global interest has shifted from medications for treating the disease, towards the race among many countries, companies and research centres around the world to develop a vaccine.
ON 9 September, the World Health Organization (WHO) website published a survey of the vaccines currently under trial. The survey was considered by the organisation as a ‘draft’ and contained a disclaimer about the accuracy, quality, safety and efficacy of the vaccines discussed.1 Nevertheless, it does include data important for any researcher.
According to the survey, stakeholders are currently competing on researching 35 vaccines subjected to clinical evaluation – only nine of which have made it to phase III clinical trials thus far. This is in addition to 145 more vaccines still under preclinical evaluation.2
Any medication or vaccine for human consumption goes through four phases of clinical trials.3,4 Usually, the clinical trial starts after the product has passed laboratory trials and animal testing. Phase I is usually conducted on a small group of healthy volunteers – not more than 100 – to examine the safety of the vaccine, discover any side-effects that could be triggered, and determine the vaccine’s appropriate dosage. In phase II, the vaccine is tested on a larger number of volunteers – 1,000 to 2,000 – who are as diverse as possible in terms of age and general health conditions, i.e., some could be healthy and some could be in actual need of a vaccine. The safety of the product continues to be a factor in phase II in addition to testing the efficacy of the vaccine in protecting against infection.
Phase III is a decisive stage due to the participation of a sufficient number of volunteers that would confirm whether the vaccine is an effective preventive intervention that would protect societies at large. Usually, scores of thousands of volunteers take part; the aim in this phase is to examine whether those who receive the vaccine are less prone to contracting the virus to a statistically significant extent. Should phase III be successful, the vaccine would be approved for use and marketed; phase IV then starts, during which data would still be collected about the effectiveness, safety and side-effects of the vaccine.
Clinical trials could go on for many years. However, the current COVID-19 vaccine trials are being conducted in record time – which has raised reservations among many researchers. Probably this is due to the availability of financial resources in addition to the competition among companies and states to be the first to produce an efficacious vaccine.
Among the vaccines that have reached phase III are those developed by Oxford University/AstraZeneca, the Russian Gamaleya Research Institute, and the Chinese CanSino Biological Inc./Beijing Institute of Biotechnology.
The first and second vaccines have lately enjoyed international media coverage as they were said to be approaching the end of the trials, with a launch being imminent. However, in early September, the Oxford University/AstraZeneca vaccine trials were suspended after harmful side-effects were reportedly sustained by a female participant in the UK (37 years) after she received the second dose of the experimental vaccine. She was diagnosed with transverse myelitis – a rare neurological disorder affecting the spinal cord.5 A few days later, Oxford University resumed the trials in the UK.6 In the US, officials believe that resuming the trials is only ‘a matter of time’ and that the case of this participant is ‘individual’. Therefore, it would be ‘unusual to suspend full clinical trials’ for this reason, according to the Director of the US National Institute of Allergy and Infectious Diseases (NIAID).7
The Russian vaccine has so far proven to be safe despite some mild side-effects, according to an article issued by the researchers committee in early September. The vaccine also showed an immune response among the participants. However, more research is needed to ensure its effectiveness in protection against COVID-19.8 Russia has approved the vaccine for limited use even as the phase III trials are still ongoing.
The Chinese vaccine has also passed phases I and II of clinical trials, where it was found to cause an immune response among most participants after the first dose. The Chinese government approved experimental use of the vaccine on the army towards the end of June.9
WHO has adopted an initiative dubbed the Access to COVID-19 Tools Accelerator (ACT Accelerator), launched in April to support the development of tests, treatments and vaccines needed globally. The ACT Accelerator has four pillars: diagnostics, treatment, vaccines, and health systems strengthening. The vaccines pillar, named COVAX, aims at the development of vaccines and their equitable distribution in all countries.10 According to WHO, this initiative brings together government agencies, scientists, companies, civil society organisations, charity organisations, the Bill and Melinda Gates Foundation, Gavi the Vaccine Alliance, the Coalition for Epidemic Preparedness Innovations (CEPI), Unitaid, the Global Fund to Fight AIDS, Tuberculosis and Malaria, the Wellcome Trust, the World Bank, and WHO.11
It is only logical that current interest is focused on COVAX, due to the vaccine development efforts worldwide. Gavi defines COVAX as a platform that will support the research, development and manufacturing of a wide range of COVID-19 vaccine candidates, and negotiate their pricing. All participating countries, regardless of income levels, will have equal access to these vaccines once they are developed. The initial aim is to have 2 billion doses available by the end of 2021, which should be enough to protect high-risk and vulnerable people, as well as frontline healthcare workers.12 Thus, the COVAX system seeks to include all countries unable to afford vaccines, by boosting their purchasing power through the single procurement platform it offers. Moreover, part of the payments by higher-income countries will cover the cost of vaccines for lower-income countries. The system adopts a model that will enable 92 lower-income countries to get equal access to the vaccines as higher-income countries.13
COVAX enables two options for higher-income economies to purchase the vaccines: a Committed Purchase Arrangement or an Optional Purchase Arrangement. Under the first option, the state commits to procuring a set number of doses through the COVAX facility in return for a relatively inexpensive advance payment (15%). The second option is not binding, as the contracting parties could terminate the purchase contract, which is an attractive option for the countries that have concluded bilateral agreements with the vaccine-producing companies. In return for this more flexible agreement, countries pay higher amounts for contracting, in addition to a non-refundable ‘guarantee’ amount – calculated according to the number of doses – to protect the COVAX facility itself against losses after having concluded supply agreements with vaccine producers.
So far, the COVAX facility has been able to obtain secure commitments amounting to $700 million, only 30% of which have materialised into legal contracts. The EU has also recently announced a commitment of €400 million to low- and middle-income countries.14
Despite the noble cause behind the COVAX facility and its clear aim to enable all to access the vaccine in the future, according to a Gavi report, there is a greater preference on the part of states for the Optional Purchase Arrangement. This places COVAX in a real financial fix that may not enable access by all countries to the vaccines. Moreover, state policies regarding vaccine supply are still individualistic, which threatens the operation of the facility altogether. Further, the pricing of vaccines through the COVAX facility still remains ambiguous; while the facility has announced the standardisation of vaccine prices at the beginning of supply, producing companies could increase the prices later, in response to the market drivers – i.e., supply and demand.
One criticism of COVAX is that it adopts an economic approach far removed from the development-oriented language typically adopted by WHO and other global health organisations. In explaining the prerequisites for joining COVAX, the classification refers to states as ‘economies’ rather than ‘developing’ or ‘least developed’ countries,15 which treats health as a commodity affordable only to economically-able countries. This approach could be due to the influence of partners outside the public health sector.
Such language reflects a shift in the approach towards public health issues globally, for reasons related to financing. Lately, contributions of member countries have ceased to be the main source for funding the WHO budget, and this could affect the organisation’s policies and direction. For instance, in 2018-2019, the US was the largest contributor of funds to WHO – at a percentage of 15.18% – followed by the Bill and Melinda Gates Foundation – at 12.12%.16 With the US having since announced its withdrawal from WHO on grounds of the COVID-19 response, the Bill and Melinda Gates Foundation could thus take over as the largest contributor, which raises many concerns regarding the impact on WHO’s future policies.17
Apart from joining COVAX, countries also seek to secure their COVID-19 vaccine supplies individually, whether through joining clinical trials or through placing pre-purchase orders from the producing companies. This has been the policy adopted by the US government, for example.
Currently, three major vaccine clinical trials are run in the US by AstraZeneca, Pfizer and Moderna. Although the trials have not concluded yet, the US government has signed an agreement with Moderna for the supply of 100 million doses of its vaccine – which is currently in the phase III trial – at a cost of $1.5 billion. This is its second such agreement, following a deal for the supply of 100 million doses of Pfizer’s vaccine candidate at approximately $2 billion.18
There is political pressure to launch an effective COVID-19 vaccine in the US prior to the November presidential elections – even if clinical trials are yet to be completed – for the benefit of Trump’s campaign. This raises concerns that the US Food and Drug Administration (FDA) could succumb to such pressures without taking account of clinical trial results. The FDA Commissioner has stated that he could issue an ‘emergency use’ authorisation for a COVID-19 vaccine prior to finalising phase III of its clinical trials. The FDA had already been seen as rushing to announce the use of COVID-19 treatment drugs with the elections on the horizon.19
As a result, future FDA decisions regarding vaccines and medicines in general could be taken sceptically. Currently, many countries worldwide, particularly developing countries, look to the FDA when it comes to decisions related to the registration of pharmaceutical products, i.e., the FDA is considered a reference organisation in this regard. Thus, when a product is registered in the US, this normally facilitates its registration in other countries. If FDA decisions are politicised, then this throws up a very disconcerting scenario.
Beyond the US, the UK has concluded contracts with six companies to secure 340 million vaccine doses. It has also inked a deal with AstraZeneca for the supply of one million doses of COVID-19 antibodies to protect those who cannot receive the vaccine, such as cancer and immunocompromised patients. Notably, this is the first time that the UK has pre-purchased a pharmaceutical product prior to its clinical approval.20
WHO stipulated in an April document that the targeted COVID-19 vaccines should ideally have at least a 70% efficacy rate – which is a standard measure for vaccines. Under urgent circumstances such as the COVID-19 pandemic, the rate should not, in any case, be lower than 50%. However, the same paper also mentions in a footnote that the minimum rate for effectiveness could be lower than 50% and that ‘[t]hese levels of efficacy are chosen based on their ability to confer important individual, public health, and indirect effects, recognising that achievement of herd immunity might also require non-vaccine interventions’.21
Of concern in this regard is that companies have started to consider effectiveness rates lower than 50% as acceptable in clinical trials. Could this mean that universally acknowledged vaccine standards – such as the number of doses, thermal stability, low cost for the largest coverage – may all eventually be disregarded in the case of COVID-19? Indeed, the danger is that vaccine developers end up competing over marketing such vaccines and achieving profit even before their effectiveness is proven.22
Heba Wanis works as a researcher with the Third World Network. Her work focuses on public health and development, particularly access to medicines, pharmaceutical policy, drug regulation and pricing, and intellectual property. She has previously worked at the intergovernmental organisation the South Centre, where she followed access to medicines and intellectual property negotiations. She also worked for several other organisations such as the United Nations Development Programme (UNDP), Plan International, People’s Health Movement and the Egyptian Initiative for Personal Rights. Wanis holds a Master’s of Public Health from the University of Edinburgh, an MA in Community Psychology from the American University in Cairo, and an undergraduate degree in pharmaceutical sciences.
The above is an edited version of an article that was originally published in Arabic in Mada Masr (www.madamasr.com) on 13 October 2020.
2 WHO. 2020. Draft landscape of COVID-19 candidate vaccines – 9 September 2020. Available at:
21 WHO. WHO target product profiles for COVID-19 vaccines. 29 April 2020. http://www.who.int/docs/default-source/blue-print/who-target-product-profiles-for-covid-19-vaccines.pdf
*Third World Resurgence No. 345/346, 2020, pp 63-65