As the country, and especially urban areas like the National Capital Region reels under threat of a winter spike in Covid-19 cases, the Centre and state governments are activating the government machinery to procure, store, transport and distribute potential vaccines to India's 1.3 billion inhabitants.
In Delhi and state capitals, meetings are being held at various levels. Prime Minister Narendra Modi is holding virtual meetings with state Chief Ministers, like the one on Tuesday. He is also attending briefings by his seniormost bureaucrats from the Cabinet Secretariat and various ministries like Home, Finance, Health and others. Additionally, these central bureaucrats are also in constant touch with their state counterparts.
The government is also planning regulatory changes to quicken the procedure of transporting vaccines for Covid-19 from and into the country. It is considering setting up air freight stations (AFS) to enable direct movement of vaccines from pharmaceutical factories to the aircraft. Export and import clearances for cargo, including customs activities like assessment, examination, and duty payment, would be provided at the AFS, which would be built near vaccine factories.
"The central government has told the states to identify the most-at-risk sections of their population, including the elderly and the infirm, as well as essential frontline workers. The plan is to vaccinate them first," said a top government official who has been part of aforementioned meetings.
"The brief has been to reduce mortality as far as possible and provide protection to the most exposed. The necessary logistics required for the vaccine have to be readied by the states and capacities ramped up," the official told Moneycontrol.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
On November 24, Modi held a meeting with chief ministers and representatives of various states to review India’s response to the Covid-19. He said that the distribution strategy for Covid-19 vaccines will be chalked out in collective coordination with the states. States should have a Steering Committee on vaccines and that distribution should be done according to scientific parameters. The prime minister also urged states to focus on adding more cold storage facilities.
The committee would be headed by the chief secretary and there would also be district-level groups that would be headed by district magistrates, the official said.
The health ministry has developed digital content for training and orientation of vaccinators. Electronic Vaccine Intelligence Network, a digital platform, tracks vaccine procurements and informs before stocks run out. This platform is being strengthened with a Covid-19 module. The system can digitally track those who have been vaccinated and when they are required to take the next doses.
Presently, there are several vaccine candidates at various levels of development. Three are in human clinical trials and two will shortly enter human clinical trials.
British-Swedish drugmaker AstraZeneca and the University of Oxford on November 23 said their coronavirus vaccine was 70.4 percent effective in preventing Covid-19. The vaccine - called 'Covishield' - was found to be about 90 percent effective in a dosage regime that involved a half-dose first and then a full dose later.
The positive data makes a strong case for AstraZeneca's India partner Serum Institute of India to seek Emergency Use Approval (EUA) from the Indian government, thereby raising hopes about the availability of the vaccine at the earliest.
"Pfizer and Moderna are out of the reckoning in India because of the cold chain requirements and possibly the price also. Pfizer is totally out of the question because of the minus 70 degrees requirement of both storage as well as transport. Moderna at minus 20 is possible, but would be costly for widespread use," said K Srinath Reddy, president, Public Health Foundation of India.
ZyCov-D from Zydus, Covaxin from Bharat Biotech and the mRNA candidate by Gennova are the other possible candidates.
The candidates that have been announced so far have to prove themselves to be safe and efficacious. Appropriate regulatory review of not just the interim results but preferably of completed trial is necessary before a widespread immunisation drive begins. All announcements so far have been media announcements with regulator approval still pending.
"If the results are spectacular, then in the interim trial itself, the regulator may give emergency use authorization. The question is, given the fact that regulatory review is still pending, all that we have seen is media announcements, and not seen the regulator getting the data. So we have to wait and watch," Reddy said.
It is essential to have some data as to whether all these vaccines work in the Indian context. "We have the Bharat Biotech vaccine coming up, the Oxford one is also there. Even in the US, vaccines will be available only on an emergency basis because we haven't seen the whole data set," Jayaprakash Muliyil, noted epidemiologist and former principal of Christian Medical College, Vellore, said.
Before going about with large-scale immunisation drives, it is essential to practice caution about the vaccines because many of them use new technologies that have little familiarity. "The mRNA vaccine is such that you're unlikely to have any serious side effects. Because of the very nature of the technology used," Muliyil said.
Distribution and immunisation
The immunization programmes currently run by the health ministry are mostly meant for children. Historically, there haven't been many examples in India or elsewhere, where the entire population, from the newborn to the old, has been immunised.
Depending on which vaccine gets the final approval, there would be a requirement for a specific number of doses. "There are certain vaccines that require two doses. Then we are not just talking about a population of 130 crores, but twice that. To do this, there needs to be a health system that has facilities and has human resources," said Amar Jesani, a consultant on bioethics and public health.
As per an assessment by Niti Aayog, health outlay by central and state governments in 2019-20 was 1.26 percent of gross domestic product (GDP).
"For decades now, the public healthcare system has been neglected, whether the public hospital at the level of cities, the smaller hospital and dispensaries in the city and then rural area district hospital, community health center and then primary health centers," Jesani said. For an immunisation programme to cover the entire population, investment in public health should have been upped.
"There are massive vacancies which need to be filled. For serious work, you cannot have people on short-term contracts," Jesani said.
Vaccines require a storage system and a distribution chain that can deliver it everywhere, from primary health centers or sub-centres in cities to villages. "You require vaccine carrier refrigeration. These logistics need to be worked out. Is there an estimation of how many syringes would be required, whether they are available and at what price would they be made available?" Jesani said.
The immunisation programme is likely to happen in phases. The government has said it would prioritize health and other essential workers.
"So, it is possible that the initial first phase is not going to require a very large volume in terms of mass vaccination. We will be immunizing some pre-identified prioritised groups. And it is not difficult again to identify those people in terms of logistics, because those workers are known, they're listed," Reddy said. The problem would be in identifying co-morbidity because not everybody who has a co-morbidity is aware of it, especially in the districts. "There age has to be the criteria, go with 60+ first and then 50+ next, etc."
According to Reddy, it is the middle phase that would be the most challenging to immunise, as one moves towards the general population. In the middle phase there would be a need for more vaccines and also the logistics become more difficult.
According to Muliyil, a lot of people in India have already been infected with Covid. This could help in reducing the burden of immunisation, depending on the scientific findings about the vaccine.
"Tamil Nadu is recording very, very few cases in most districts. These districts, remember, have a population of more than a million, and many districts are reporting single-digit cases. So if it is due to the fact that they are approaching herd immunity, then there is no emergency need for a vaccine in those sort of situations," Muliyil said.
According to him, many people would not need a vaccine, because they have been infected already and that is one factor that could be advantageous for a hugely populous country like India. "At the moment, we don't have any easy technology. If in Delhi, it doesn't come down by the time the vaccine is available, I would focus on people above the age of 50," Muliyil said.
Cold storages and last-mile connectivity
The prime minister himself and health experts and officials have highlighted the need to focus on adding more cold storage facilities. According to a Crisil Research report, the present cold storage network in India is pegged at 226.7 lakh tons. Approximately, there are about 7,645 cold storages in the country with 68 percent of the capacity being used for potatoes, while 30 percent is used for multi-commodity cold storage. However, the organized part of it is considered to be lesser than 10 percent.
"Other than the Pfizer vaccine which needs -70 degree celsius, all others (announced so far) can be stored in latest cold storages," said Sunil Nair, CEO, Snowman Logistics. Snowman has a presence in 15 cities with facilities equipped to store up to -30 degree celsius.
Snowman is in deliberations with vaccine manufacturing companies for storage solutions. "While the discussion is healthy, it is inclusive as there is still lack of clarity on what role the government and its policies are going to play in the vaccine distribution. It may take a couple of months for all the stakeholders to get clarity on this," Nair said.
There would be last-mile challenges in villages and talukas. The government already has an immunization programme in place, where it reaches up to primary health centres and community health centres."Considering the volume involved and the urgency, it will be a challenge. Private operators will have to be roped in for storage and transportation right up to these vaccination points," Nair said.