Staring at Vaccine Famine?

    14-Dec-2020
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Rich nations–where 13% of the global population live–have booked 52% of vaccines. Equipped with better manufacturing and supply capabilities, India can emerge as a beacon hope for the world
 
-K M Gopakumar
 

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As part of the British Immunisation programme, Margaret Keenan, a 90-year-old
British grandmother became the first person in the world to receive the
BioNTech-Pfizer COVID-19 vaccine outside of a clinical trial
 
 
In the early stage of the pandemic outbreak, experts identified vaccine development as a top priority area in the fight against Covid-19. In the light of disinterest among the pharmaceutical companies to invest in vaccines for infectious diseases, various governments and philanthropic foundationspumped in funds to accelerate vaccine development. Vaccine projects across countries managed to rake in funds to the tune of $5 billion. Irrespective of Pfizer’s claim of not receiving any public funding for the vaccine development, the data show that the German government provided $375 million to its partner BioNTech to develop the vaccine technology. Similarly, another frontrunner Moderna received 1 billion funding for vaccine development form the US government. This huge public funding resulted more than 320 vaccine candidates at different stages of development. Many world leaders, including the Secretary General of UN and French President, promised that the vaccine against Covidwould be treated as a global public good thus available to people in every nation. However, there is little action to convert the concept of public good into reality.
 
Of late, with a few vaccine candidates reaching the stage of approval, there is a growing concern about availability of vaccines at an affordable price. The recently approved Pfizer vaccine is priced in US is $19.50 per dose. One person needs two doses. Though Pfizer promised a differential price for low and middle-income countries, including India, the exact price is unknown. This means the developing countries cannot afford to purchase this vaccine unless there is a substantial cut in cost. Cost is not the only barrier. There is doubt about the availability of the products in short time to meet the rising demand.
 
In the absence of scaling up of production through multiple manufactures, people living in developing countries cannot have timely access to the vaccine. According to a study prepared by Oxfam, developed countries – where 13% of the global population live–have booked 52% of Covid-19 vaccines. Substantial quantum of the two vaccines produced by Pfizer and Moderna, which have claimed high efficacy rate, has been booked by developed countries. This underlines the urgent need to diversify vaccine manufacturing base. This will lead to Covid-19 vaccine famine in the world.
 
Unprecedented public funding as direct grant or as advanced purchase agreement fully de-risked the vaccine companies. Despite big funding, developed countries and pharmaceutical multinational companies are not ready to part with the technology to create large-scale production. The only exception is the AstraZenca-Oxford, which has licensed its vaccine to Serum Institute of India (SII) to supply in India and other low and middle income countries. However, in the absence of diversified manufacturing, a majority of people living in developing countries will be deprived of access to vaccine in the short run.
 
India holds the key
 
COVAX Facility, a global initiative aimed at working with vaccine manufacturers to provide countries worldwide equitable access to safe and effective vaccines created by Gavi, is targeting to provide 2 billion doses to cover 20% of the population consisting of health workers, elderly and people having comorbidity. There is no clarity about facilitating access to general population.
 
This scenario demands concrete actions from India, which is known as the ‘Pharmacy of the Poor’ due to its ability to produce medicines at cheaper rates. India needs to repeat its success in the pharmaceuticals in the vaccine space. Covid-19 reminds of us of the stark realities of technology divide in the world and its implications for the people in developing countries. India is one of the few countries which have vaccine manufacturing and supply capabilities. India has the capacity to produce nearly 8.2 billion doses of vaccines annually counting all the existing technology platforms except the newest mRNA vaccine platform. It calls for urgent steps to ensure Atma Nirbhar (self-sufficiency) in the vaccine development and production to meet the current and future threat to our health security.
 
The Indian government and pharma companies are making all efforts using their existing technological capabilities to develop an affordable vaccine. Currently there are at least 20 vaccine candidates are under the different stages of development in India. Out of these 20 vaccine candidates, three are in very advanced stages development i.e Phase III clinical trial (AstraZenaca-SII, Bharat Biotech Limited (BBL) and Zydus Cadila (Zydus). mRNA, the latest technology platform is part of the 20 vaccine candidates currently in development in India.
 

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While SII obtained the technology from Oxford University, Bharat Biotech is partnered with ICMR Virology Institute in Pune and Zydus is using its own technology. Even as these firms are having their vaccine candidates at Phase III trial stage, they are also collaborating with other actors to develop more Covid-19 vaccines. These three companies in the past successfully developed low-cost vaccines. For instance, BBL developed first ever vaccines for typhoid.
 
In 2010, Zydus developed vaccines for H1N1 diseases.The Department of Biotechnology announced Rs 900-crore grant to support vaccine development apart from the earlier announced Rs 300-crore assistance form the PM Cares Fund.
 

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As scientists say there is no failure in research and development, the investment and effortsfor Covid-19 vaccine development, irrespective of its success or failure, will lead to enhancing capacity. This experience will equip them to face the next pandemic and also to develop the next generation vaccines for some of the existing infectious diseases. In that spirit, there is a need for following transparency with regard to the data on vaccines which can bring great degree of respect on the Indian scientific establishment.
 
A vaccine is a preventive tool and therefore it has the ability eradicate a disease. From abusines perspective, this is not a good proposition because eradication of a disease through a successful vaccine is also the end of the business. Therefore, companies do not show much interest in the development of vaccines comparedto medicines. However, vaccines are critical to protect the health security. Therefore, vaccine development and production cannot be left solely to the private players. The government instead of withdrawing from vaccine production and development should play the role of an entrepreneurial state. Towards this purpose, the government should actively pursue a policy of modernisation of India’s public sector vaccine facilities.
 
 
VAX-ing Eloquent on AtmaNirbhar
 
To become self-reliant on the pharma sector, India needsto focus on these areas:
 
(a) A majority of APIs (Active Pharmaceutical Ingredients), Dis (Drug Intermediates) and KSM (Key StartingMaterials) are imported, primarilyfrom China and this trend must bereversed by effective policy and incentive interventions
 
(b) Most of the components/ reagents/enzymes/ antibodies used in diagnosticand medical devices are also imported, and therefore start-up/incubatorsmust be funded and tax-incentivisedto innovate and manufacture medical devises and diagnostics indigenously.
 
(c) Greater emphasis to be placed onsupply chain to prevent recurrenceof avoidable outages of essentialmedical supplies and services.In just six months, the country hasemerged stronger and self-reliant withsupport from all sections of the society,particularly the scientific, medical andindustry stakeholders. However, greaterfinancial support is required for innovation institutions and industry to reduceimport dependency of APIs, medical devices and diagnostics. The pathway for atruly AtmaNirbhar Bharat in a modern,knowledge-driven world lies in harnessing Indian talent by enabling, encouraging and empowering the inventions,innovations and industry.
 
 
Broadening Base
 
The global vaccine market is controlled by a few firms. Five firms share 80% of the global vaccines sales. Commercial activities of these firms are heavily focussed on the industrialised countries and a set of emerging markets such as Brazil and China. However, to address the criticism of lack of participation of developing countries, these multinational corporations started co-opting developing country manufactures through licensing agreements to supply in low- and middle-income countries. From a long-term perspective, this creates vaccine dependency.
 
The competition in the vaccine market is controlled primarily through using two sets of instruments viz. Intellectual Property Rights (IP) and regulatory framework. IP Rights like patents and trade secrets create barriers for the competitors to develop same vaccine. Patents provides a statutory monopoly and prevent the competitors form using the patented technology or products during the lifetime of the patent i.e. 20 years. Apart from this, the competitors require a range of information known as know-how such as the characterisation of the vaccine, cell lines, manufacturing process, etc. Often know-how is protected through trade secrets. Unlike patent, there is no duration of protection for trade secrets. As a result, many such pieces of information are protected perpetually. Though many Indian firms have the ability to discern the know-how behind a vaccine, the regulatory framework does not encourage that process.
 

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Substantial quantum of the two vaccines produced by Pfizer and Moderna,which have claimed high efficacy rate, has been booked by developed countries. This underlines the urgent need to diversify vaccine manufacturing base
 
In the case of small molecule medicines, the regulatory agencies primarily look at whether the end-product of the competitor is same as that of the originator. Therefore, a generic manufacturer of a medicine need not prove the safety and efficacy of the medicine through clinical trials. This makes the generic medicine extremely cheap compared to the originator. Often generic firms sell their product at least 90% cheaper than the originator. However, in the case of biologics -- the medical product using proteins form living organisms like vaccines-- the assumption is that manufacturing process is critical and therefore identical product developed through a different manufacturing process need to prove the safety and efficacy through extensive clinical trials. Since the originators protect the know-how through trade secret and refuse to share the manufacturing process. The competitor is forced to depend on a different manufacturing process.
 

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Prime Minister Narendra Modi recently visited vaccine manufacturing facilities in the country
 
This use of independently developed manufacturing process forces the competitor to carry out clinical trials to prove safety and efficacy. This require time and resources and make the development process costly. In the case of biotherapeutics, there is a regulatory guideline to develop a non-originator product with a smaller number of clinical trials. Many scientists are questioning the science behind such requirement and requested the WHO to reconsider the need for such clinical trials for non-originator. In the case of vaccines, there is no such regulatory pathway currently existing to obtain marketing approval for a non-originator vaccines. As a result, every competing manufacturer is treated as a new vaccine developer and has to carry out extensive clinical trials. This regulatory insistence of clinical trials is to be re-examined in the light of developments in science and technology. Otherwise, the regulatory framework is using façade of safety and efficacy concern to stifling the competitionand thereby eliminate the possibility of affordable vaccines.
 
Thus, a combination of IP protection and regulatory requirements stifles the competition market. In order to address the IP challenges, the Indian Government along with South Africa and Kenya approached the WTO to waive the obligations of protection and enforcement of copyrights, industrial design, patent and trade secret under the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). This proposal is gaining more support among WTO members and currently 100 countries are supporting the proposal. Countries like Mozambique, Pakistan, Bolivia, etc., became the cosponsors of the waiver proposal. The rationale behind the proposal is to take away the IP protection of technologies and products related to Covid-19medical products so the multiple producers can scale up the production without any fear of sued for the infringement of IP such as patent. The presence of multiple manufactures is to create competition in the market and reduce the price. The TRIPS Council meeting held on December 10 decided to continue the discussion till the completion of the 90 days and report to the general council for further action/guidance.
 
The global vaccine market is controlled by a few firms. Five firms share 80% of the global vaccines sales. Commercial activities of these firms are heavily focussed on the industrialised countries and a set of emerging markets such as Brazil and China
 
This proposal if approved even empowers the government agencies to reveal the know-how protected as trade secret by the original vaccine developer to facilitate competition. Since the regulatory reform require time the waiver of IP obligations can enable the access to critical information to scale up production through multiple producers. India should take the lead at the international and approach WHO to reform the existing vaccine regulatory framework to facilitate competition in the market to ensure availability and accessibility.
 
The Indian government should show the leadership in translating the idea of global public good into a reality by offering free access to vaccines to all citizens and making them available at affordable prices to other countries. Further, upon request the government could facilitate technology transfer to scale up manufacturing in other developing countries.
 
(The author is the Legal Advisor and Senior Researcher with Third World Network)