In an interview with Outlook, Union health minister Dr Harsh Vardhan talks about the preparedness of the government’s vaccination programme—to be put to a stern test once a Covid vaccine is available. Emphasising that the government has been putting together all the disparate details of this humongous planning and logistical exercise at breakneck speed, he expresses confidence that all Indians shall get a COVID-19 vaccine.
India runs one of the world’s biggest universal immunisation programmes. Yet, by comparison, the COVID-19 vaccination effort will be more gigantic. What are the questions the government is considering right now? At what stage are the preparations?
Yes, we already implement the world’s largest immunisation programme of the world, with 26 million infants added every year. We have an established infrastructure for the supply, storage and delivery of vaccines to the last mile under our Universal Immunisation Programme, where we administer around 600 million doses to children annually. We have conducted largescale polio vaccination campaigns for over two decades now, and recently conducted the world’s largest measles-rubella campaign, covering more than 330 million children. We are augmenting this system to ensure that the massive national mission of vaccinating the identified priority groups with COVID-19 vaccine is achieved in a timely manner. India’s accomplishment in eradicating polio is the most impressive global health success story that the world has ever seen. I have no doubt that we will achieve any target that we set.
A national expert group on vaccine administration for COVID-19 (NEGVAC) has been constituted under the chairpersonship of Dr V.K. Paul, member, health, at NITI Aayog, to guide on all aspects of COVID-19 vaccine—implementation, selection of vaccine candidates, procurement mechanisms, financial resources etc. The national group has been reviewing the preparatory steps for vaccine delivery.
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We already have a robust system of electronic Vaccine Intelligence Network (eVIN) through which real time information of vaccine stock availability and their storage temperature across all cold chain points is available. Most importantly, Prime Minister Narendra Modi has been fully involved in the matter and has been personally monitoring it. With strong political will and immense ground-level work, I would say that our preparations are on track and we will be able to successfully provide a COVID-19 vaccine to all citizens in a phased manner.
Some of the vaccine frontrunners are hopeful of getting efficacy data by next month or year-end. Which are the candidates under consideration by the government?
The pace at which vaccines against COVID-19 are being developed is unprecedented. In India, nearly 30 groups, both in academia and industry, are actively involved in development, collaboration and trials for COVID-19 vaccines. Of these, about five vaccines are in the clinical stage of development. These include an indigenously developed DNA vaccine candidate, ZyCoV-D, by ZydusCadila; Covaxin, the inactivated whole virion candidate vaccine developed by Bharat Biotech International Ltd; ChAdOx1-S, a non-replicating viral vector vaccine developed by University of Oxford/AstraZeneca; Russian vaccine Sputnik V and Biological E of US origin, which is a protein subunit (recombinant) receptor binding protein. Given our huge population, we will explore multiple vaccine candidates subject to their licensing by the Drug Controller General of India.
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India has the highest vaccine manufacturing capacity in the world. What approach is the government taking to ensure availability? As chairman of the executive board of WHO, have you been able to play a pivotal role?
The government is deliberating with vaccine manufacturers and planning every detail for the availability of different COVID-19 vaccines. Our aim is to provide the COVID-19 vaccine to 30 crore Indians by August-September 2021. This is a good 22 per cent of our total population. Indian manufacturers who have vaccine candidates in various stages of clinical trials have been in talks with the government through NEGVAC to ensure timely supply.
WHO has launched Access to COVID-19 Tools (ACT) Accelerator to accelerate development, production, and equitable access to COVID-19 diagnostics, therapeutics, and vaccines. One of its pillars is the COVAX facility, which aims at securing two billion doses of COVID vaccine by the end of 2021. India, as a participating country in the facility, is likely to benefit. As chairman of WHO’s EB, I have the privilege of coordinating this humongous task.
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How shall we go about a vaccine roll-out? Can you elaborate on the various operational requirements in view of our current capacities?
Our eVIN tracks all vaccines in the country for stocks and storage temperature till the last facility. So, eVIN will be used for tracking COVID-19 vaccines too. It’s being modified to incorporate COVID-19 Vaccination Beneficiary Management System (CVBMS) for individualised tracking of all beneficiaries. It will generate electronic vaccination certificates. A database of healthcare workers has already been initiated. Subsequently, the session sites for vaccination will also be mapped.
Vaccines are thermo-sensitive products and require specified temperature ranges for their storage and transport. We have a robust cold chain and supply chain management system. We have carried out an assessment of additional cold chain requirements for COVID-19 vaccine across the country. Procurement has been initiated for ice-lined refrigerators, deep freezers, walk-in-coolers and walk-in-freezers. The NEGVAC expert group has mapped the necessary manpower needed to administer the vaccine. Online training platforms like ECHO and iGOT will be utilised for capacity building of our large workforce for administering the vaccine.
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The expectation is that initial doses of a vaccine will be available in mid-2021. How are priority groups being decided? How many people are we targeting in the initial year?
We are indeed prioritising certain occupational groups and age groups; it is being deliberated by the NEGVAC expert group. Our first priority will be healthcare workers. The second priority will be frontline workers of other departments. This will be followed by other priority groups. We must remember that 80 per cent of Covid deaths in India have been in the age group above 50 years.
What is the current estimate of the costs involved?
Our government is committed to providing the COVID-19 vaccine to each and every citizen of India and has enough resources to finance the same.
The ongoing routine immunisation is a critical component of healthcare in itself. How do we ensure that this is not affected by a COVID-19 vaccination effort?
Undoubtedly, routine immunisation programmes did suffer an initial setback. But we seized the first available opportunity to set it right. With the possibility of a COVID-19 vaccine, we have asked states to form high-level coordination groups at state and district levels. These must ensure minimal disruption of routine immunisation and other health services by Covid vaccination.
A second wave has resulted in lockdowns in Europe. How worried are you about the current situation in India given the festival season, elections and bypolls in many states and the approaching winter?
We recognise the fact that there is enhanced survivability of viruses in colder environments and the propensity of viral infections to peak in winter months. We have issued standard operating procedures on preventive measures to contain the virus’s spread during the festive season. For polls, the Election Commission has issued guidelines. We are in continuous touch with all states and UTs and have asked them to penalise those flouting the pandemic rules of safety. We have also advised states to keep a strict watch on all festive activities.
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Kerala had been singled out as a state that responded efficiently to COVID-19. However, its infection numbers have been rising rapidly. What could have gone wrong?
Between January 30 and May 3, Kerala reported 499 cases and only two deaths. Later, phased unlocking and increased movement of people across borders led to more cases. In July 2020, cases initiated largely from a fishing colony in Thiruvananthapuram, followed by clusters in Ernakulam, Alappuzha, Kasargod, Kollam and Malappuram etc. This changed the case trajectory of the state. Spikes were seen in the state’s epidemic curve due to Onam festivities in August and September 2020. Unchecked movement of people due to trade, tourism, festivities etc. increased the risk of transmission. Other states should learn that the coming festivities, if not properly managed, may see a sudden spurt in cases.
With the healthcare system engaged in the COVID-19 response, what has been the impact on other illnesses?
Like in every nation, COVID-19 has posed a public health challenge in India and has strained the public health delivery system. For example, there has been a drop in TB notification rates (almost 45 per cent) in the initial months. A similar drop was observed in notification rates of seasonal influenza and non-communicable diseases like hypertension and diabetes. With sustained focus in the past four months on non-Covid health services, the situation is improving. Regular reviews are being conducted with states/UTs to ensure that essential non-Covid services do not get adversely impacted. Funding to ensure the same has also been provided.
Has the FELUDA COVID-19 testing kit been rolled out? Is it true that it is as good as qRT-PCR, and much faster?
The reason that the FELUDA technology is similar to qRT-PCR (quantitative reverse transcription polymerase chain reaction), while being much faster, is that only the q (quantitative) part has been replaced. This quantitative part that gives Ct values during detection needs a qPCR machine that measures fluorescence of the product with every cycle of PCR. This makes it very specific, but also slow. Techniques that use RT-PCR without the qPCR machine have been non-specific because a wrong PCR reaction will also be detected. Otherwise, a simple RT-PCR run takes 30 minutes. The FELUDA technology has the sensitivity and specificity of qRT-PCR, but reduces the time and eliminates the need for 20-30 lakh qPCR machines. It is premature to say if it will replace RT-PCR and rapid antigen tests.
Is the virus mutating in India? You have earlier said that no mutation of coronavirus has been detected in the country.
Let me give you the ancestry of the circulating SARS CoV-2 in India. As many as 2,276 virus samples across the country were taken, sequences from other institutions retrieved from GISAID network were used and genome sequencing was done. We found the variation in clades less than 1 per cent, which is not really significant for virulence. We believe the virus is genetically stable so far. The pan-India 1000 SARS-CoV-2 RNA consortium sequences viral whole genomes of 1,062 Covid-positive individuals. Whereas haplotype diversities peaked between March and May, during the early part of the outbreak, A2a (20A/B/C) emerged as predominant haplotype. The temporal haplotype diversities landscape appears to be spread across India.
Union minister Dr Harsh Vardhan visits a Covid shelter in Delhi.
In India are we only using antigen kits or are we conducting antibody testing as well?
RT-PCR and antigen-based tests are mainly being used for providing laboratory diagnosis of the disease, primarily for treatment and contact tracing. Molecular closed system platforms like TrueNat and CBNAAT are also used for disease diagnosis. Antibody-based IgG ELISA/ CLIA tests are being used for repeated serosurveys, which are being conducted by various states as well as by ICMR. ICMR has conducted two nationwide serosurveys using antibody tests in 24,000 and 28,000 individuals respectively, in 70 districts.
How can the government give Bharat Biotech Phase 3 clinical trial approval when its Phase 1 and Phase 2 vaccine trials are not available for peer review?
Peer review is neither prescribed in NDCT Rules nor mandatorily required before allowing the subsequent phases of clinical trial for any new drug, including vaccines. The safety and efficacy results of Phases 1 and 2 clinical trials generated by Bharat Biotech were evaluated in consultation with subject expert committee for consideration for a grant of Phase 3 clinical trial. Based on the results and the recommendation of the panel, CDSCO has granted permission for conduct of Phase 3 clinical trial.
How does the Phase 1 and Phase 2 clinical trials compare for various vaccines under trial in India—size,end points, participant, demographics, etc?
Vaccines are heterogeneous; thus vaccines from different manufacturers may differ in respect of technology/platform used. If the platform used is a new one, it is treated accordingly to ascertain its safety and efficacy. In India, for example, permission was granted to conduct Phases 1 and 2 clinical trials of Covid vaccines to Bharat Biotech and Cadila Healthcare Ltd wherein the technology used by the firms are different. However, primary end points and secondary endpoints, sample size, population etc. of the two studies are comparable. Primary end point in both Phase 1 clinical trials are safety assessment while that in phase 2 clinical trials are immunogenicity assessment. The secondary endpoint in both Phase 1 clinical trials are immunogenicity while that in the Phase 2 clinical trials are safety assessment. Details of the trials of both are available on the Clinical Trials Registry of India website (www.ctri.nic.in).
What uncertainties do you face in your mission to provide a vaccine to each Indian citizen?
The biggest uncertainty is that the vaccine may not work. The next challenge could be that vaccine availability could be slower than we calculated. Vaccines may have to be imported, which will then throw up a need for reprioritisation. Then vaccine efficacy may wane after 6-12 months. However, I am an optimist, seeing that there are so many candidate vaccines, where the whole world is collaborating. Once a part of the population is vaccinated, cases will decline, making it far easier for us to contain the virus. There could be a good chance that we may not even need to vaccinate the entire population!
What have been your lessons from the pandemic?
We have learnt immensely from this catastrophe. The pandemic has taught us that therapeutics, diagnostics, and vaccines for the whole world are the only way out. Global collaboration is paramount. We need to also focus on creating effective health systems for improved pandemic preparedness. The pandemic is underscoring the critical role of international collaboration on the frontiers of science and technology. Now that we are on the threshold of a COVID-19 vaccine, this is the time to ensure that access to diagnostics, therapeutics, and vaccines is fair and equitable. Access to protection from a dreaded pandemic should not—and cannot—be a factor of the ability to pay.
There has been a spiritual lesson from the pandemic. India has once again shown the world that when its people set an ambitious goal, more than a billion minds get ignited and India’s promise on delivery against social responsibility can be endless!
