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India’s road to mass vaccination against Covid-19

The wait for Covid-19 vaccine is over. The vaccination programme to protect people from the coronavirus has rolled out to combat the pandemic, which has killed more than 1.73 million people globally and infected 78 million people since late December last year. The first human cases of Covid-19, the disease caused by the novel coronavirus, were reported by officials in Wuhan City in China, in December 2019. The UK became the first country in the world to start administrating its citizens with Covid-19 vaccine which was soon followed by several other nations. The US and Canada began inoculations with the vaccine developed by Germany’s BioNTech and American drug-maker Pfizer. Confronting its worst health care crisis in a century, doctors, nurses and the elderly rolled up their sleeves across the European Union, the 27-nation bloc, to receive the first doses of the coronavirus vaccine. The coordinated rollout was conducted even as new virus variant that has been spreading rapidly around London and southern England has been detected in France, Italy, Spain, Canada and Japan. The new variant, which British authorities said, is much more easily transmitted, has prompted many countries to restrict travel from Britain. Germany’s BioNTech has, however, claimed that it was confident that its vaccine would work against the new UK variant.

The Most Pressing Challenge

 The whole world waited for the vaccine as the last resort to control the coronavirus outbreak that has gripped the planet for months now. Launched in April by the World Health Organization (WHO), the European Commission and France in response to this pandemic, COVAX has the world’s largest and most diverse portfolio of Covid-19 vaccines. It aims at providing equitable access to vaccines and ensure that people in all corners of the world will get access to Covid-19 vaccines once they are available. No doubt, developing a vaccine against Covid-19 was the most pressing challenge in the prevailing scenario. Every country was racing to produce vaccines to save their people. As the best bet against the virus, they strategize to secure more shots to protect their populations against the novel coronavirus infection. During the ongoing pandemic, hundreds of companies and thousands of researchers have been studying vaccines and developing drugs at an unprecedented pace to save the mankind.

India is the second worst-affected country from the coronavirus infection after the US. The country has recorded in excess of 10 million cases of the viral disease, and suffered over 1,46,000 deaths. Only silver lining is that India’s per-million statistics are better than most countries (including those in the Organization for Economic Cooperation and Development, a club of rich nations), and the case fatality rate is among the lowest in the world in such a large country. India targets to meet the challenge of immunizing 300 million people in the next six months, and hundreds of millions more by the end of the year. Needless to say, the sheer scale and urgency of administering Covid-19 vaccines poses a stiff challenge to even those who were part of in India’s success story in immunization — the country never had to immunize this size of people in six months in the past. Given strong demand for Covid-19 vaccines, India’s government is likely to order a huge chunk of the vaccines.

 A National Commitment

Getting vaccines to the world’s second-most populous country with 1.3 billion people is a big step forward in the battle against the pandemic. Prime Minister Narendra Modi, who is regularly briefed on the Covid-19 situation and all aspects of the vaccine plan, says that providing the coronavirus vaccine is his government’s “national commitment.” During a series of meetings with the state chief ministers and two all-party meetings over the last six months, Modi said that the government was in touch with both Indian vaccine developers and manufacturers as well as international pharmaceutical companies and that states had to make the necessary preparations for storage and handling of vaccines. On November 28 last year, Modi visited the facilities of Bharat Biotech International Limited, Serum Institute of India and Zydus-Cadila Limited to see first-hand how these companies were getting along with their vaccine development and manufacturing. India is the only country that has the capacity to manufacture anti-Covid vaccine for the entire world, Australian Ambassador Barry O’Farrell had said after visiting the Hyderabad facilities of two pharmaceutical companies working on vaccines.

India, the world’s biggest vaccine maker (India manufactures more than 60 per cent of all vaccines sold across the globe), has set for the massive global efforts to contain the coronavirus pandemic with its pharmaceutical industry and partners freeing up capacity and accelerating investments. The nation will play a pivotal role in immunizing much of the world.Médecins Sans Frontières once dubbed the country the “pharmacy of the world”. Its role in manufacturing a vaccine could come in two different ways — massproducing one developed elsewhere or developing a new vaccine as well as manufacturing it. At present Pfizer BioNTech, Moderna, Sputnik V and Sinopharm vaccines are being administered to people in over a dozen countries.

Covaxin, being developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and Covishield vaccine made by Serum Institute of India (SII), which has partnered with British pharmaceutical company AstraZeneca, have already applied for authorization. Other six candidates (four of these vaccines being developed indigenously) are in different stages of trials to test safety and efficacy. ZyCov-Di is being developed by Ahmedabad-based Cadila Healthcare Ltd. Another vaccine is being developed by Hyderabad-based Biological E, the first Indian private vaccine making company, in collaboration with US-based Dynavax and Baylor College of Medicine. HGCO19, India’s first mRNA vaccine is being made by Pune-based Genova in collaboration with Seattle-based HDT Biotech Corporation. Bharat Biotech is in the process of developing a nasal vaccine. The Sputnik V vaccine is being developed by Dr Reddy’s Lab and Gamaleya National Centre in Russia. Yet another vaccine is being developed by SII and American vaccine development company Novavax. Of course, vaccine will be introduced in the country only after the regulatory bodies like Central Drugs Standard Control Organization (CDSCO) clear that it is based on its safety and efficacy. The Covid-19 vaccine introduced in India will be as effective as any vaccine developed by other countries. That is why various phases of vaccine trials are undertaken to ensure its safety and efficacy. Pune-based SII is the largest vaccine manufacturer in the world. Biological E has agreed to manufacture the vaccine candidate of Johnson & Johnson’s subsidiary, Janssen Pharmaceutica NV. On August 7, Gavi (the global vaccine alliance) announced a collaboration with the SII and the Bill & Melinda Gates Foundation. The deal provides financial support for the Serum Institute to manufacture and supply 100 million doses of vaccines to the Covid-19 Vaccine Global Access Facility for distribution in low and middle-income countries in 2021. The deal supports the company’s manufacture of both the AstraZeneca and Novavax candidates.

AstraZeneca’s candidate will be available to 57 Gavi-eligible countries, while the Novavax treatment will be available to 92. SII has already stockpiled more than 50 million doses of the AstraZeneca shot, even as it awaits emergency-use approvals from both British and Indian authorities. SII plans to make a total of 400 million doses of Covishield by July and is setting up new production lines to roll out roughly one billion shots a year. Adar Poonawalla, the Serum Institute’s CEO, said, “A majority of the vaccine, at least initially, would have to go to our countrymen before it goes abroad”. Another Indian pharma firm Aurobindo Pharma has entered the vaccine fray by inking an exclusive licence agreement with US-based COVAXX, to develop, commercialize and manufacture a vaccine to fight Covid-19 for India and UNICEF. Indian companies have also drawn up plans to scale up their vaccine manufacturing capacities. They are in the forefront in making and supplying vaccines for Covid-19 isstill rocking the world.

Thus we see that pharma companies in India have expertise in large-scale manufacturing and distribution of generics.They are also well-equipped to manufacture and distribute vaccines. The country now contributes 40-70% of the WHO’s total demand. Further, it has a robust and resilient supply chain with specialized patient-centric distribution channels that enable last-mile delivery.

An opportunity to expand companies’ CSR footprint

Soon after the Covid-19 outbreak in March, the Corporate Affairs Ministry (MCA) had announced that spending of Corporate Social Responsibility (CSR) funds for Covid-19 are now treated as eligible CSR activity. Now, it has gone a step further to even treat the R&D spend on Covid-19 vaccines, drugs and medical devices as eligible CSR spend. The MCA has amended the CSR Rules 2014 to allow such companies to bring R&D spends on new vaccine, drugs and medical devices development for the financial years of 2020-21, 2021-22 and 2022-23 as part of their ‘CSR policy’. In effect, such spends can be considered as ‘CSR activity’ so long as certain conditions are met, the MCA has said.

The change in norm stipulates that research on Covid-19 vaccine, drugs and medical devices will have to be undertaken in collaboration with organizations mentioned in Companies Act 2013, which prescribed the list of permitted CSR activities. These organizations include Indian Institute of Technology (IIT); Indian Council of Medical Research (ICMR); Indian Council of Agricultural Research (ICAR); Council of Scientific and Industrial Research (CSIR); and laboratories and autonomous bodies established under Department of Atomic Energy; Department of Biotechnology; Department of Science and Technology; Department of Pharmaceuticals and Ministry of AYUSH. However, companies engaging in R&D spend on Covid-19 vaccines and collaborating with the specified government organizations will have to separately disclose the details of such activity in the Annual Report on CSR included in the report of the Board. Analysts said the amendment would provide necessary fiscal relief to companies engaged in research activities for development of Covid-19 vaccine as they would be able to adjust their research related expenses towards their CSR obligation.

India already runs several mass immunization programmes for children inoculating more than 40 million newborns and pregnant women against various diseases every year but penetration of vaccines across all age-groups is low. Government must leverage corporate social responsibility (CSR) programmes and prepare a sensitization plan to increase awareness about the vaccine, and ensure that people take the vaccine properly — that is, take both doses at the correct interval. For those discharging their obligations, Covid-19 pandemic is putting them to test. As the economic activity has gradually resumed after several months of lockdown due to pandemic and a large amount of CSR funds have already been committed to the PM CARES fund, companies should strive to use this crisis as an opportunity to expand their CSR footprint.

FAQ on Covid-19 vaccine:

CSR Times’ medical expert, Dr. Minnie Bodhanwala, answers some of the questions regarding vaccine safety and efficacy.

Why is it important to get vaccinated against Covid-19?

Covid is a disease which affects all age groups and can progress rapidly destroying the lungs and causing thrombosis and multi organ failure and death. It is very unpredictable and there is no proven drug which can halt this virus completely and prevent its morbidity and mortality. So it is imperative that we prevent this infection from causing serious disease, this is where a vaccine will deliver. It prevents serious morbidity and mortality.

Covid is a novel virus and we do not have any immunity against it and nor have we fully understood how it causes such a deadly disease. Many medicines have been repurposed as treatment but to no avail, so research has focussed on the vaccine and it has been delivered to us in a record time of nine months and we should take it as it is our best weapon against the disease.

Is it necessary for a Covid-19 recovered person to take the vaccine?

Yes. As getting the disease does not give long lasting immunity and antibody levels wane over a few months, reinfection has been seen in some individuals. There is doubt whether antibodies produced after infection are protective antibodies or are they just neutralising antibodies. This makes the vaccine indispensable even for those who have had the disease.

What should be the main criteria for selection of the initial groups to be offered the vaccine?

The main criteria is susceptibility to the disease. Those groups who would be at the highest risk of getting the disease as health care workers, police, municipal/government workers working for control of disease should be the first ones to get the vaccine followed by people above 55 years with or without comorbid conditions like hypertension, diabetes who are at high risk of severe disease and then pregnant women and adults and the last group being children who rarely develop severe disease .

How prepared is India to carry out a mass vaccination campaign?

India is well prepared for mass vaccination and most of the states have had dry runs and have enhanced cold storage facilities. The MOHFW has already published detailed SOPs and training of personnel by the states has been completed. We have done mass immunisation for oral polio, MR vaccine and small pox vaccine in the past and the workforce is geared up for this massive challenge. As the vaccine is stored at 2-8 degrees celsius, cold chain challenges are minimized.

What should be government’s strategy for a vaccination programme of the scale India needs?

The target groups mentioned above should be first categorised and documented by use of technology. Vaccine transport and storage logistics have to be worked out and each vaccination centre should have a nodal person to take care of exigencies. Each state needs to have a central cell monitoring it at district level and then at state level.

It should run in a mission mode utilising both public and private health care setups as the numbers are huge and speed is the key. In the next few months some more vaccines will get clearance so we should be having enough vaccines for at least one dose to be given to a majority of the population especially the vulnerable groups.

Should vaccine against Covid-19 be given for free to, at least, a few sections of society?

Yes. Health care workers / police and government or municipal workers who have worked for control of the disease and have borne its brunt should be given free vaccine for their heroic efforts. The weaker sections should be given vaccine free as each dose would cost around 200 rupees which many sections of the society in India may not be able to afford for the whole family. The affluent sections of the society could pay for the vaccine as due to our huge population it may be near impossible for our government to give everyone free vaccine .

Will vaccinated people still need to wear mask?

 Yes. The vaccine does not prevent asymptomatic or mildly symptomatic infection. It builds your immunity so that serious disease is avoided but you can still transmit the virus if you get infected. So universal use of mask, hand hygiene and social distancing will remain till the pandemic is officially called off.

Will new Covid strain found in the UK affect vaccine?

The vaccine induces antibody production against the spike protein which is the cause of all the ill effects of the virus so the strain should not affect this and give us good protection against any mutant virus. It is known that the new strain is more infectious but does not cause severe disease We have to follow the course of the pandemic post vaccination to know how the mutant has affected it. Anyway in India only a few people have been isolated with the mutant virus and in the last one month there has been no spike in the number of cases.