Pharma companies are madly competing with each other when it comes to finding the first effective vaccine against COVID-19. Because of its topical importance, this race is not just between corporate companies alone. It has expanded to being a global competition between various countries (at both centre and state levels) invoking geo-politics. This tight race against time for finding a vaccine to inoculate the whole world is unprecedented in human history.
High Stakes Involved
The sheer volume of expected sales for such a vaccine at the moment is breathtaking. It’s a big money game running into billions of dollars. Hence it is not a surprise that many companies want to win this jackpot. “COVID vaccine is going to be a life saving drug and its sales plus distribution should be considered from a humanitarian point of view. It should not be used as a tool for making exorbitant profits by companies to exploit the poor and needy,” explains K.K. Shailaja Teacher, Minister of Health and Social Welfare for Kerala.
“All nations need to be given licenses and granted equal opportunity in the production of these life saving vaccines. International agencies like the UN and International Court of Justice should consider intervening, if necessary, to give a level playing field for all countries on this global public health matter,” adds Shailaja, who has become a global female icon and role model in the fight against COVID.
Vaccine Stockpiling
Rich and prosperous countries are giving advance orders to stockpile hundreds of millions of doses in advance. Poorer countries are unable to match on this hoarding race because of the astronomical costs involved.
Sudden stockpiling at present market prices by richer countries could ensure prices for vaccines not to drop in near future. This in turn would not make life easier for poorer countries. This pandemic and global vaccination drive is going to bring in a multi-faceted economics problem as well.
Who Pays for Vaccines: Government or People?
In health insurance driven countries, it is still unclear whether insurance companies would take care of the costs or whether their citizens will have to pay an additional premium for getting vaccinated. In European countries, there is no full clarity as to whether the state would bear all the costs for vaccinating the entire population. In African countries, it is not clear whether other richer countries or international organisations would step-in to help them.
Due to the severity of the circumstances, companies are requesting the FDA for an early deployment of vaccines even before the clinical trials end. The scientific data provided by these companies thus far show that their respective vaccines are indeed effective. However, the current clinical trials being carried out are not double blind, and therefore there is an ethical responsibility to let the volunteer know whether they are in the placebo group or not, once the study becomes unblind.
— Dr Sreejith Rajasekharan,
Virologist at Laboratory of Molecular Virology, International Center for Genetic Engineering and Biotechnology, Italy
COVID vaccine is going to be a life saving drug and its sales plus distribution should be considered from a humanitarian point of view. It should not be used as a tool for making exorbitant profits by companies to exploit the poor and needy. International agencies like the UN and International Court of Justice should consider intervening, if necessary
— K.K. Shailaja Teacher,
Minister of Health and Social Welfare for Kerala
While vaccine availability will be one end-point, we should remember that distributing vaccines will take time and that we will need to maintain restrictions around physical distancing and masks for a good while to come
— Prof Gautam Menon,
Infectious diseases modelling expert at Institute of Mathematical Sciences, Chennai
India’s High Population and Centre/State Cooperation
In highly populated countries like India, it is going to be a huge budgetary challenge to inoculate more than a billion people. It is still not clear how the centre and state are going to share these huge costs. Generous donations from philanthropists might only cover some tens of millions of doses inside India which is still a small fraction of our population.
In limited budgetary constraints, how to pick and choose the subjects for free inoculation is another tricky subject. Besides all this, even political parties are trying to score brownie points as to where and when free vaccines will be given. It is not yet clear whether only the healthcare workers will be vaccinated or whether the whole general population will be included for free inoculation.
Vaccine Administering Challenges
In addition to direct costs of vaccines, there will be added logistical costs regarding its transportation, storage, administering etc. Vaccinating the whole of India uniformly in a short span of time is going to be a logistical nightmare.
Some states have higher budgets than others. Some states have more robust health care systems than others. Besides budget, the most crucial point is the cold chain challenge — i.e. retaining the efficacy of vaccines from point of manufacture to point of administering. Feasible cold chain management plays a key role in selecting one vaccine over a list of other available vaccines. Massive transportation and storage at a permissible range of deep freezing temperatures is a massive challenge in countries like India.
“While vaccine availability will be one end-point, we should remember that distributing vaccines will take time and that we will need to maintain restrictions around physical distancing and masks for a good while to come,” advises Prof Gautam Menon, infectious diseases modelling expert at Institute of Mathematical Sciences, Chennai.
Why Developing Vaccines Take Time?
Vaccine candidates are first tested in animal models (pre-clinical validation). Only the most promising will be carried on in a clinical trial. This trial proceeds step by step, involving an increasing number of human subjects.
“It begins with a small group of healthy volunteers (phase I). If the response to the vaccine is good (no severe side effect but a good immune response), the number will scale up involving hundreds (phase II) and later thousands of volunteers (phase III). It is a blind placebo-control trial: part of the volunteers receives the vaccine, the remaining receive a placebo but they don’t know in which group they are. The volunteers for phase III should be chosen in countries in which the virus is actively circulating because, to calculate the efficacy of the vaccine, you need to compare the number of infections in the vaccine group with the one in the placebo group. This is the stage in which the most advanced COVID-19 vaccines are,” explains Dr Giuditta De Lorenzo, a virologist at MRC-University of Glasgow Centre for Virus Research, UK.
At the end of the clinical trial, all the collected data are reviewed by the regulatory agency (i.e FDA or EMA). Only when the agency gives the final approval, the vaccine is considered safe enough to be introduced in the population as part of the vaccination programmes.
“Usually, all together, this takes several years but the speed of the COVID-19 vaccines development has been impressive. Never in history a vaccine reached phase III in such a short amount of time. That was possible because of new technologies available but mostly because the urgency of the situation justified a huge investment of money, a simplification of bureaucracy and the redirection of many resources to this project (putting on hiatus many other research projects). But as efficient as the system can be, there is still a physiological time that needs to be respected: to mount an immune response after the vaccine, to spot any possible side effects and, for the volunteers, to encounter the virus and confirm their protection.” adds Dr De Lorenzo, who works on latest viral research.
Fast Tracking — Pros and Cons
When this process is being fast tracked in the present circumstance, it will help to instill more confidence and less fear in the minds of the general public and COVID victims. However fast tracking this comes with its fair share of cons too. “Due to the severity of the circumstances, companies are requesting the FDA for an early deployment of vaccines even before the clinical trials end. The scientific data provided by these companies thus far show that their respective vaccines are indeed effective, and an early release absolutely makes sense. However, such an ‘emergency use’ approval will certainly compromise the ongoing clinical trials not only of these vaccines, but also for those which have just started. The current clinical trials being carried out are not double blind, and therefore there is an ethical responsibility to let the volunteer know whether they are in the placebo group or not, once the study becomes unblind.” elaborates Dr Sreejith Rajasekharan, a virologist at Laboratory of Molecular Virology, International Center for Genetic Engineering and Biotechnology, Italy.
None can be directly blamed in this context because the demand and pressure are unprecedented from various interest groups. “As soon as the vaccine will be made available, these volunteers have the right to take the vaccine, and therefore can no longer be included in the control group. If too many volunteers cross over, the study might not have sufficiently large control groups to obtain statistically significant results for certain long-term goals,” adds Dr Rajasekharan, virologist who was part of the team that sequenced SARS-CoV-2 genome in early March 2020.
(The author, Dr Aswin Sekhar, is a scientist and science writer)
(Part 2, tomorrow)
