The risks the country needs to prepare for, precautions it needs to take, the logistics required and, above all, the implications of it all for India’s health system
“It’s in the news. I am 60 years old and I can register to get the vaccine,” says a jubilant Vivek Kumar (name changed), an auto driver in Delhi who comes in contact with multiple passengers every day. He believes that the vaccine would keep him and his family safe from the novel coronavirus disease (COVID-19).
Monika (name changed), a household help in Delhi, is also eagerly waiting for the vaccine. She says most people did not want her to enter their houses even after the lockdown was lifted. She might get those jobs back once vaccinated. But Monika will have to wait longer than Vivek as she is barely 40 and without any comorbidity. Her profession is also not on the list of services prioritised under the mass vaccination programme, which will be rolled out sometime in January to combat the raging pandemic.
The SARS-COV-2 virus has more than 10.5 million people across India, killing nearly 152,000, by January 14, 2021. Worldwide, the tally was over 92 million people and death toll at 1.9 million.
More than a dozen countries have already initiated mass vaccination against COVID-19. China and Russia have been inoculating people for more than three months now with their own vaccine candidates, but these are under scrutiny as data related to their safety and efficacy are not available in the public domain.
A glimmer of hope emerged December 2, 2020 when the United Kingdom — known for stringent drug regulation — gave emergency use authorisation (EUA) to a vaccine developed by biotechnology company BioNtech SE along with pharma giant Pfizer Inc. A week later, the country launched a mass vaccination campaign.
As of now, most countries that have rolled-out vaccination against COVID-19 are using Pfizer-BioNtech’s Comirnaty. But they are diversifying their procurement as other vaccine developers declare the results of their clinical trials and regulatory agencies give them safety clearance.
India too has chosen multiple vaccines: Oxford-AstraZeneca’s Covishield, being rolled out by Pune-based Serum Institute of India (SII), and the indigenous Covaxine by Hyderabad-based Bharat Biotech. The roll-out date has been set January 16.
On December 8, Rajesh Bhushan, secretary, Union Ministry of Health and Family Welfare (MoHFW), assured that every Indian who needs the vaccine would be vaccinated. But this is going to be a gargantuan task fraught with challenges, starting from logistics to distribution and administration of the vaccine.
India has prepared a vaccine roll-out plan based on the country’s experience with the election process and the universal immunisation programme — some 610 million people voted in the 2019 General Elections and at least 26.7 million newborns and 29 million pregnant women are routinely provided 390 million doses of vaccines each year.
This is, however, the first adult vaccine to be rolled out at such a scale in the country. In the first round of vaccines, MoHFW plans to cover a third of India’s 900 million adult population; children will not be covered as paediatric vaccine is yet to be developed. Some 1 million of the targeted population will be healthcare workers, 20 million frontline workers, such as the police, paramilitary and municipal workers, and 270 million will be those above the age of 50 or with comorbidities.
Since India is considering multiple COVID-19 vaccines, which may require different time gaps between the two shots, maintaining the schedule will add to the challenge. One can gauge the sheer size of the exercise by comparing it with the UK, which plans to vaccinate just 20 million of its population initially.
The roll-out would be coordinated by the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) with VK Paul, member NITI Aayog as the chairperson and Balram Bhargava, secretary at the Department of Health Research, MoHFW, as the co-chairperson.
NEGVAC has a tentative blueprint for vaccine delivery, distribution and administration at the levels of state, district and block — the state steering committee will be chaired by the chief minister, district task force by the district collector and block taskforce by the sub-divisional magistrate. These groups have to identify the priority population to be vaccinated and put in place a system so that each vaccination session runs smoothly.
To help them, the government has put in place the CO-WIN digital platform (formerly called eVIN or Electronic Vaccine Intelligence Network, which was developed in 2015 to monitor immunisation among children). Individuals will be able to enroll on the platform which will confirm the date and time for the vaccine. Once successfully administered, the app will also issue certificates. The platform will provide a host of information to the authorities starting from the available vaccine stocks to the temperatures in the cold chain.
The country will rely on its existing system to monitor adverse events following immunisation, which was developed in 1986. The system has a standard operating procedure implemented by different agencies including the National Technical Collaboration Centre, Central Drug Standard Control Organisation and doctors. This is important as side-effects have been recorded globally, including the UK where at least two people reported skin rashes and breathlessness after taking the first shot of the vaccine.
Other than this, the government is depending on the existing cold storage infrastructure — 85,634 functional cold storage equipment and 28,947 cold chain points — for the first round of vaccination. The vaccination would be carried out by the auxiliary nurse midwives (ANMs), community health workers operating at the village level.
MoHFW has said it plans to employ 154,000 of the 239,000 ANMs for the same. India plans to spend $1.4-1.8 billion on the first phase of the vaccination programme, as per GAVI, which is a global vaccine alliance. The country has allocated $10 billion to healthcare in 2020-21.
A scientist working on COVID-19 vaccine at Serum Institute of India, the largest vaccinemaker in the world. Photo: Reuters
The MoHFW so far prepared a 113-page COVID-19 Vaccines Operational Guidelines, which was shared with state governments December 15. It has not been released in the public domain.
“The blueprint for vaccination is an evolving document. Action would be determined by multiple factors keeping disease epidemiology in mind. For example, higher doses will be given to states where the disease is spreading faster,” says Chandrakant Lahariya, public policy and health systems expert and co-author of Till We Win: India’s Fight against COVID-19 Pandemic.
Who will finally get vaccinated is also unclear. The government has announced that 1 million healthcare workers would be vaccinated first. The problem is that the country has more than 6 million healthcare workers, according to the National Health Profile, 2019. This means only one in six healthcare workers would get vaccinated initially. As the decision to take the vaccine is voluntary, the government might be hoping that few healthcare workers would come forward to avail it.
Similar problem exists in identifying people with comorbidities. “The country does not have a database on people with comorbidities and identifying them will be difficult. How will the vaccinators know? Will the people have to carry a certificate? Who would issue the certificate?” asks Lahariya.
People who want to be vaccinated will need to register with CO-WIN. However, CO-WIN is not active at the moment and there is no way to register or clear these issues. One only hopes that these problems are resolved before any of the vaccine is given EUA by the government.
Moreover, the urgent demand for a vaccine has also given rise to ethical issues with vaccine manufacturers pushing their products. Bharat Biotech applied for EUA while it had barely started phase 3 trials.
There are also issues about patient safety. In case of the Covishield trials, a 40-year-old Chennai-based participant developed neurological symptoms and had to be admitted to an ICU after he received the vaccine and had to stay in the hospital for some 25 days. He asked for a compensation of Rs 5 crore and the legal notice alleged that no public disclosure was made even after the participant reported his condition. The lead researcher of trial, however, says that no relation between the vaccine and the adverse effects were found. In similar circumstances, the UK reacted immediately and suspended trials till the matter was investigated.
Under the pretext of urgency, a number of shortcuts in development procedures at the pre-clinical stages and even at the clinical stages may have taken place. “Adverse effects will occur and claims of compensation from volunteers will become common,” says Mohan D Nair, an expert on the global pharmaceutical industry. He says there is no clarity on dosage, booster frequency, effect on diverse organs and functions.
If the SII case is an example, there is no succour for patients. SII has filed a counter lawsuit against the vaccine participant for defamation, calling the allegations “malicious and misconceived”.
“We want more transparency. The Indian authorities are more conservative in releasing information. Most of the information that is coming out is sponsored by the manufacturer. Here, there is a conflict of interest at play,” says Anant Bhan, a public health expert and former president of International Association of Bioethics.
Instead, the regulator should provide the information and build confidence. This is very important now because we would be giving EUA and we need more confidence in our regulator. The regulator has to build confidence, adds Bhan.
Boxes of the COVID-19 vaccine by Moderna ready for shipping at the McKesson distribution centre in Olive Branch, Mississippi, USA. Photo: Reuters
Irregularities in clinical trials are coming to light globally too. On November 23, interim data from Covishield trials in Britain and Brazil were released and the company reported that their vaccine is 70 per cent effective. However, it was found that the efficacy of the intended protocol is actually only 62 per cent. Some participants were given only half a dose of the vaccine to begin with, followed by a full one.
The efficacy of this approach seemed to be about 90 per cent. The company merged the data and reported higher efficacy. It is not clear why some people were given half the dose and whether the results should be considered robust as this group was only a small fraction of the total and was not fully representative of the population.
These instances of oversight are even more perilous as new reports from the UK suggest that the virus has mutated and is now more easily transmissible virus has emerged in the country. This has sent shockwaves across the medical fraternity.
In a recent webinar series, organised by SAMA-Resource Group for Women and Health, Satyajit Rath, visiting professor at the Indian Institute of Science Education and Research in Pune, analysed the clinical trials and pointed to a lack of uniformity in the information provided by the developers. While some trials included the elderly, others did not.
Most trials did not clearly indicate the participation of people with comorbidities. While some were screened for prior exposure, others were not. Some investigators gave information about the placebo used, others did not. Rath said this problem could have been averted through “solidarity” vaccine trials — where vaccines would be compared against each other — but vaccine capitalism has taken control.
The fact that the industry is in the game only for profits has become clear as many countries — where these companies are based — have refused to support a proposal to waive off Intellectual Property Rights (IPR) on drugs and pharmaceuticals needed to prevent, diagnose and treat COVID-19. The proposal was put forth by India and South Africa on October 2 and has the support of 100 countries. This would allow countries to neither grant nor enforce patents related to COVID-19 drugs, vaccines, diagnostics and other technologies for the duration of the pandemic.
Countries such as Australia, Brazil, Canada, the European Union, Japan, Norway, Switzerland, the UK and the US — which always back the interests of their pharmaceutical corporations — are against the proposal. The TRIPS Council has asked for more time to consider the proposal and negotiations would continue in 2021. The subject would be discussed formally at the TRIPS Council session on March 11-12, 2021.
The refusal to waive patent rights on COVID-19 vaccines is despite the fact that public funding has been driving COVID-19 research and development. For instance, it has been reported that Moderna Inc’s vaccine is 100 per cent public funded. In addition, billions of dollars are being spent by governments on purchasing the vaccine.
“Innovations that are created collectively should be governed in the public interest and should not be under monopoly control,” Leena Menghaney of Médecins Sans Frontières told Down To Earth. This assumes even more importance when it comes to developing a vaccine in the context of a pandemic, she says.
The world is also facing the problem of “vaccine nationalism”. Developed countries have pre-booked a lion’s share of the vaccines that would be developed. Rich countries with just 13 per cent of the world’s population have already purchased over 50 per cent of the scheduled vaccine production, says a position paper by the All-India Peoples Science Network.
As these are confidential agreements, the terms and conditions are not in the public domain. For India, this is a cause of major concern as several Indian vaccine manufacturers too have signed agreements to manufacture leading vaccines developed elsewhere that are bound by confidential agreements made with COVAX, a global collaboration that aims to guarantee fair and equitable access to COVID-19 vaccines, and also with their corporate partners as regards to prices and supply schedules.
Voluntary licences granted by vaccine developers to Indian manufacturers prevent the latter from transferring the technology to other Indian companies or from exporting to countries not covered by COVAX. India’s public health experts fear that it would be difficult for Indian vaccine manufacturers to scale-up vaccine production and supply to the levels required by India, quickly.
COVID-19 vaccines have potentially changed the way the world looks at vaccine development. This is now the fastest vaccine to be developed, much faster than the five years it took to develop the mumps vaccine. Here, it is important to remember that the vaccine for human immunodeficiency virus (HIV) is still not ready despite nearly four decades of work.
Researchers working on the COVID-19 vaccines have been able to fast-track work using technologies, including artificial intelligence that allows quick identification of vaccine candidates. The process could also be fast-tracked because these could use technologies that were developed for other vaccines, but remained in experimental stages because of lack of funds.
For instance, the use of mRNA for the vaccine is one such experimental technology which has been revived by fresh funding. Shahid Jameel, director of the Trivedi School of Biosciences at the Ashoka University, Sonipat, explains that though mRNA-based technology is not used in any approved human vaccine, the platform has been developed over the years.
This technology turned out to be an easy and scalable platform for COVID-19 vaccine. In contrast, the tried and tested vaccine technologies such as the live attenuated vaccines take years to develop. Similarly, protein vaccines are unpredictable as proteins are hard to make and fold properly, Jameel adds.
Faced with the urgency to find a vaccine, researchers have even fast-tracked the clinical trials. Many steps carried out sequentially earlier have now been carried out in a parallel manner. For example, Moderna did not wait till the final results of the animal trials and started planning for the next phase of clinical trials. There have also been cases of overlapping phase 1 and phase 2 trials, and phase 2 and phase 3 trials and even these phases have been shortened.
Also, regulators around the world have cut down their dossier review and approval time from months to days. This used to happen between every phase of human testing. Experts feel that this is a good development.
“Fast-tracking of regulatory timelines is a very positive outcome of vaccine development which ought to be extended to drugs as well,” says Kiran Mazumdar-Shaw, executive chairperson, Biocon, an Indian biotech company. Science and data analytics have enabled these compressed timelines through risk-benefit analysis. We need rapid responses to viral pandemics as well as to other diseases as the current regulatory timelines are too lengthy and slow to reach life-saving drugs or vaccines to people in time, she says.
“The COVID-19 vaccines have made people realise the importance of vaccines both globally and nationally,” says Lahariya. This understanding of the importance of vaccine and new technologies could have long-lasting impacts. For years, researchers have tried to find vaccines for neglected diseases, but never had enough funds. Now as neglected diseases become mainstream and money is available, researchers can finally find a way to reduce the burden.
“We learn from every vaccine,” says Jameel. For example, a company called Codagenix is using a novel technology called codon deoptimisation to make live attenuated COVID-19 vaccines. “If it is successful, it will show a new way to make highly efficacious vaccines for emerging pathogens. New ideas and technologies are constantly needed to tackle new emerging pathogens,” says Jameel.
A Mexican soldier at a vaccination drill. Photo: Reuters
As more and more countries start vaccinating, there is pressure to provide emergency licence to one of the vaccines quickly. Even Prime Minister Narendra Modi visited all the vaccine manufacturers in the last week of November. But India has to be patient and license a vaccine only when the industry provides foolproof data. To build trust, there must be complete transparency on the results of the clinical trials.
More importantly, the government must ensure that the selected vaccine is distributed rationally, equitably and ethically in the country. Already, there are fears that it will be first launched in the private market, and this will create inequities between those who have purchasing power and those who are eligible, as per WHO recommendations.
To avoid this, the government should run the immunisation programme only in public health institutions. “The government must consider the COVID-19 vaccine as a public good, which is above commercial competition for access, availability and affordability,” says Antony Kollannur, a public health expert based in Kerala.
In this effort, India’s lack of a robust public health system is a hurdle. Due to this, the country has not reached a satisfactory level of immunisation even in children. In the case of polio immunisation, which has an immunisation rate of above 98 per cent, it has been possible only because it is administered orally. This is different from the COVID-19 vaccines which have to be injected and require experienced health personnel.
“In my experience in piloting the JE Vaccine in Bellary in 2006-07, the biggest challenge was getting adequate nurses,” says Kollannur. Jameel agrees, “Our challenge will be to chart out the distribution network and ensure trained human resource to vaccinate. Our current capacity to deliver vaccines is about 1.5 million doses per month or 18 million doses per year. At this capacity, vaccinating 800 million people (or 1.6 billion doses) will take 89 years!”
The world is watching India as many of the vaccine manufacturers are based here and it will play a critical role in ensuring that other developing countries have access to the vaccine.
Some vexed questions remain. We could save precious vaccines if we could figure out whether to go for universal immunisation or whether there is a need to vaccinate people who have survived the infection. Till the time these questions are answered, one may try to find solace in what has been told to us till today: That the pandemic might end naturally in February. Or will it?
This was first published in Down To Earth’s print edition (dated 1-15 January, 2020)
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