Covid-19 vaccines are considered essential to curb the spread of SARS-CoV-2, the virus that causes the coronavirus disease. The global community is waiting for a vaccine, hoping that life will return to normal. Vaccines are the most successful and cost-effective public health investments in history with more comprehensive benefits that accrue over a lifetime. The epidemiological and economic impact of Covid-19 vaccines, therapeutics and subsequent heath system rejuvenation, has a significant beneficial social impact.
More than 200 Covid-19 vaccines are in the pipeline around the world. Around 154 vaccines are being explored in preclinical lab experiments and animals, 21 are in Phase 1 of clinical trials undergoing safety tests in healthy young individuals, 13 in Phase II being tested in broader groups of people while 10 are in Phase III undergoing large international trials to test their impact on Covid -19. However, no vaccine has yet been approved and licensed for general use.
Promising results from vaccine trials present new ethical and logistical challenges. Manufacturing the vaccine and distributing it among people are both critical. A public health system to distribute the vaccine effectively is as important as the Covid-19 vaccine itself.
The global pandemic has already caused loss of hundreds of thousands of lives and disrupted the lives of the entire humanity. An effective vaccine is expected to contribute to saving lives and getting the pandemic under control. According to Global Alliance for Vaccine and Immunization (GAVI), a leading international NGO that works for global vaccination efforts for preventable diseases, the introduction of a vaccine will prevent the loss of $375 billion every month.
There is a growing consensus that global equitable access to a vaccine, particularly protecting healthcare workers and other at-risk people, is a critical element to mitigate the public health and economic impact of the pandemic.
The socioeconomic impact of the Covid-19 pandemic will be far-reaching and long-lasting. The World Bank warns that 115 million people will be pushed into extreme poverty in 2020. Covid-19 is also poised to increase inequity as pandemic-related job losses and deprivation affect poor and vulnerable people most acutely. Poverty could result in further barriers to engaging with the health care system. Disruption due to chronic non-communicable diseases may further overburden fragile health care systems.
Demand for an effective Covid-19 vaccine is enormous. According to WHO, the demand is for 2 billion doses of vaccines fairly distributed by the end of 2021 and Covid19 related therapeutics of 245 million treatment courses within 12 months delivered to Low and middle-income countries (LMIC)
According to WHO the Global Vaccine market is controlled by the governments of industrialized and developing countries, pooled procurement agencies, the private sector, and the various regulatory and advisory bodies, overseeing vaccine quality and safety.
The High-Income Countries (HICs) constitute 82% of global vaccine sales in terms of value, corresponding to about 20% of the annual volume of vaccines sold. Often the HICs pay higher prices for the vaccine, and they contribute to the discovery of newer vaccines.
In the vaccine market, the private sector plays, in general, a relatively small role on the demand side, except in some countries with rapid economic growth, where demand from middle classes for new vaccines can be of significant value. As WHO further estimates, only 5 to 10% of total vaccine sales are in developing countries. Private sector demand is mainly fuelled by affluent population segments in developing countries that decide to take on responsibility for their immunization, using preferred options not offered by the public sector.
The sustainability of immunization programmes depends on the government’s ability to be efficient and sustainable in the long term. The sustainability of the immunization programme is the capacity of country immunization systems and processes, to carry on with or without external financial and other support.
Many countries have made significant progress in developing their general immunization programmes and introducing new vaccines. However, many countries are still struggling to ensure efficient and sustainable immunization programmes. Issues of success of vaccination programs are linked to several factors, including decision-making, political commitment, financial support, demand for immunization services and access to affordable and timely supply of vaccines.
The Covid-19 pandemic is also an opportunity to strengthen the health systems. Many developing counties need to develop systems to use new tools as they become available and upgrade the supply of Personal Protective Equipment (PPE) and Oxygen.
An effective Covid-19 Vaccine may prompt business leaders to confidently look forward to quickly ending the crisis around the world. The business confidence thus generated will have much more generous social benefits such as increased employment opportunities and rebuilding of the economy. It is expected that as an outcome of the positive news about covid19 vaccine, consumer confidence could come back by mid-2021. However, the use of the mask, physical distancing, and ventilation would still be necessary for many more months.
Scientists around the world are developing many potential vaccines for Covid-19. These vaccines are all designed to teach the body’s immune system to safely recognize and block the virus that causes Covid-19. According to WHO, several different types of potential vaccines for Covid-19 are in development. They are:
- Inactivated or weakened virus vaccines, which use a form of the virus that has been inactivated or weakened, so it doesn’t cause disease, but still generates an immune response.
- Protein-based vaccines, which use harmless fragments of proteins or protein shells that mimic the Covid-19 virus to safely generate an immune response.
- Viral vector vaccines, which use a virus that has been genetically engineered so that it can’t cause disease, but produces coronavirus proteins to generate an immune response safely.
- RNA and DNA vaccines, a cutting-edge approach that uses genetically engineered RNA or DNA to generate a protein that itself safely prompts an immune response.
Scientists in Britain, Germany, China and the United States are trying to develop a new vaccine technology based on deploying messenger RNA to trigger the immune system. However, this technology has never been approved for use. Nevertheless, these cutting-edge RNA vaccine efforts have moved forward as top candidates to fight Covid-19.
Recently, the leading pharmaceutical companies, Pfizer and Moderna reported preliminary results from their phase 3 Covid-19 vaccine trials is to be at least 95% effective in preventing coronavirus illness. A third vaccine, from AstraZeneca, is also reportedly highly effective. This news provides greater impetus and range of opportunities for policymakers to reduce the crisis.
The Russian “Sputnik-V” vaccine produced an antibody response in all 76 participants. But the sample size of the trial participants was small and elderly population was not represented in the study. The Russian Direct Investment Fund (RDIF) The sovereign wealth fund of Russia and the Indian pharmaceutical company Hetero agreed to produce more than 100 million doses per year in India of the Sputnik V vaccine.
WHO has identified the need for a fair allocation mechanism for Covid-19 vaccines. Along with GAVI, WHO has recently established Access to Covid-19 Tools (ACT) Accelerator program. ACT is currently the most extensive global collaboration program working to accelerate development and production and to ensure equitable access to new Covid-19 technologies. According to this plan, all countries, regardless of their developmental or economic status should have access to a share of these products once they are available.
WHO advises that once a vaccine(s) is confirmed to be safe and effective, and authorized for use, all countries should receive doses in proportion to their population size, albeit initially in reduced quantities. This will enable every country to start by immunizing the highest priority populations. As per WHO, fair allocation of vaccines will occur in the following way:
- An initial proportional allocation of doses to countries until all countries reach enough quantities to cover 20% of their population. A follow-up phase to expand coverage to other populations.
- If severe supply constraints persist, a weighted allocation approach would be adopted, taking account of a country’s Covid threat and vulnerability.
- WHO also has proposed a robust ethical framework to guide the global Covid-19 vaccine access program. Solidarity, accountability, transparency, responsiveness to public health needs, equity and fairness, affordability, collaboration, regulatory and procurement efficiency are the principles which should guide the vaccine access program.
These principles allow for tailoring of the allocation mechanisms according to different contexts and product use, with particular focus on reaching high-risk populations living in conditions of vulnerability, and those who carry out functions essential for the well-being of others and society.
While it seems the scientist community has managed a breakthrough, several critical determinants of access to vaccine remain. One of the critical element of access is related to financing vaccines, including the clinical research behind the vaccine. As compared to the pharmaceutical market, the vaccine market is relatively small; hence most of the vaccine-related scientific breakthrough has taxpayer support.
The policy and program enablers to ensure vaccine access to U.S. patients are worth examining. The US government has committed to buying hundreds of millions of doses of vaccines in advance to ensure Americans were among the first in line if an emergency-use authorization or approval from the FDA comes through. The Trump administration agreed in July to pay almost $2 billion for 100 million doses, with an option to acquire as many as 500 million more, once that clearance comes.
As part of that agreement, the US gets to decide who gets the vaccine first and will work with the company on logistical support. Most vaccine front-runners have been encouraged by operation Warp Speed which will distribute their doses through a government partnership with McKesson Corp.
Pfizer is planning to handle the delivery of its products. The company has designed reusable containers that can keep the doses at ultracold temperatures and is organizing trucks and flights to move them.
The U.S. Government’s “Operation Warp Speed” is working at full speed along with several other vaccine programs, including the one from Moderna Inc. that uses technology similar to Pfizer’s and could produce trial data later this month.
The Trump administration’s rapid-vaccine operation programs are led by the Health and Human Services Department, the Defence Department, and other agencies. Whichever pharmaceutical company makes the vaccine, U.S. citizens may receive the vaccine in 2021, because of the “Operation Warp Speed”.
The leading vaccine producer, Pfizer’s German partner BioNTech SE, has received money — from the German government. The Berlin government gave the German company $445 million in an agreement to help accelerate the vaccine making by building out manufacturing and development capacity in its home market. Though the results from Pfizer, Moderna and AstraZeneca are promising, the issue of easy vaccine availability is yet to be resolved, the regulatory approval and monitoring systems are yet to be in order.
Covid-19 vaccine presents implausible complexities of production and distribution such as how will the vaccine be quickly and efficiently delivered and dispensed? Who gets it first? Will countries limit access to it?
Overall, there is a consensus on four main groups as potential early Covid-19 vaccine recipients: health care personnel, other non-medical essential workers, those with high-risk medical conditions and adults aged 65 years or older.
In the Indian context, this also may present additional challenges. Vaccines have to reach the healthcare workers in remote areas of the country. In the absence of a national older peoples policy, reaching all the at-risk population above the age of 65 presents additional challenges. All the institutional homes for the elderly in the country need to be mapped to ensure timely access to Covid-19 vaccine.
Most of the people aged 65 years or older are also people with other high-risk conditions. Obesity, diabetes, cancer and cardiovascular disease are prevalent among them, or they live with someone who has such conditions.
Evidence of unequal risk and differential access to treatment of vulnerable populations highlights the need for a national policy that reduces subjective decision making. A Covid-19 vaccine access policy must be guided by epidemiology, science, and bioethics.
In a paper published in The Journal of Infectious Diseases, Richard K. Zimmerman, and colleagues from the Pittsburgh School of Medicine, proposed a framework on how to allocate limited initial doses in the U.S. Using the theories of egalitarianism and utilitarianism, they proposed a three- to four-tier approach. The first tier is supported by both theories: those with the critical skills needed for society during a pandemic, such as health care providers, police, firefighters, and makers of vaccines and therapeutics required for treatment of Covid-19. The second tier includes individuals who experience the highest medical benefit. According to the authors, egalitarianism supports prioritizing the medically neediest or those most likely to die from Covid-19, whereas the utilitarian approach suggests balancing medical need with the likelihood of protective vaccine response to protect the largest number of people
The efficacy of the vaccine still raises questions. There are at least a half dozen other vaccines in development that have entered final (phase 3) trials. Most of the leading vaccine candidates relay on an RNA based technique, focusing on a spike protein on the part of the virus’ surface that penetrates human cells.
Coronavirus being a newly discovered pathogen, a scientist can’t predict how long the vaccine immunity will last in individuals. A vaccine that lasts just a few months is barely useful. Two-year immunity is on the high end of expectations, according to the researchers of at the University of Minnesota. Coronaviruses are unlikely to produce such long-term immunity. Also, crucial to containing the pandemic is whether a vaccine prevents infection or only illness. A vaccine that prevents only against illness will not stop the virus spread.
Even when the vaccine is ready, it is unlikely that all are ready to access it immediately due to many reasons. ‘Vaccine hesitancy’ refers to delay in acceptance or refusal of vaccines despite the availability of vaccine services. ‘Vaccine hesitancy’ was named as the World Health Organization’s (WHO) top global health threats in 2019. Vaccine hesitancy is complex and context-specific, varying across time, place and vaccines. It is influenced by factors such as complacency, convenience, cultural and religious beliefs and confidence.
Complicating matters, the majority of vaccines under development will require two doses given 21- or 28-days apart, and two of the leading candidate vaccines have different handling requirements and must be stored at different temperatures.
The logistics of vaccine distribution present further challenges. The new Pfizer Covid-19 vaccine that was found to be 90% effective will need to be refrigerated at -70 to -80 degrees. Whereas, most hospitals can only refrigerate at around -2 to -8 degrees. The Oxford University/AstraZeneca vaccine which Serum Institute is doing the trial in India could be kept in regular fridge temperature. The vaccine of Moderna Inc, which is working on a vaccine based on similar technology, does not need to be stored at such a low temperature. Other vaccines including ones from Johnson & Johnson and Novavax Inc can be stored at 2-8 degrees C, the temperature of a regular refrigerator.
The cold chain requirements are likely to slow down the rollout in the developing world as well. Ensuring that over a billion people are vaccinated is as critical as developing the vaccine itself. Even an effective coronavirus vaccine will not return life to normal immediately. A vaccine is often seen as the magic bullet that will end the pandemic, however, we need to consider what a vaccine can achieve, as it could take up to a year for a complete vaccination program roll out.
A vaccine offers excellent hope for potentially ending the pandemic, but we do know that the history of vaccine development is plagued with failures. Vaccine alone, i.e. a techno-fix may not end the pandemic. A strengthened health system, adherence to physical distancing, consistent use of mask and frequent washing of hands are still required. A government policy on access to Covid vaccine, therapeutics, and a healthcare system focussed on a ‘Health First’ approach are pre requisites in the rebuilding of the post Covid-19 society.
(Dr Joe Thomas is Associate Dean, Faculty of Sustainability Studies and Professor of Public Health and Sustainable Development, MIT World Peace University, Pune.)