A Long Shot
On June 27, Prime Minister Narendra Modi spent almost 10 minutes of his monthly 30-minute Mann Ki Baat address to the nation on a call with representatives of Dulariya, a village in the district of Betul, Madhya Pradesh. The interaction was about Covid-19 and carried a message the Prime Minister wanted to convey to his pan-Indian audience — the importance of vaccination. Modi emphasised that mass vaccination is the only way to arrest the spread of the pandemic that is destroying lives and livelihoods.
Weeks earlier, the Modi government had set a December 31, 2021 deadline to vaccinate approximately 94-crore citizens and provide Covid cover to all of India’s adult population. With each person requiring two doses, it meant administering close to 190-crore jabs in the next five and a half months — a herculean task given that only around 40-crore doses have been given since India began vaccinations early this year. To meet the target, around 150-crore doses of Covid-19 vaccines need to be administered (90 lakh jabs daily on an average till December 31) and the government has been struggling to create an ecosystem to make that happen.
Domestic manufacturing of Covid-19 vaccines are being ramped up, a liberal approval process for foreign vaccines okayed by developed countries is in place, quality testing facilities have been added, logistics and supply chain mechanisms have been strengthened and private healthcare providers have been roped in. However, all of these are in an evolving phase and what Modi’s Mann Ki Baat touched upon was just the last critical piece — public support — that needs to be in place to make India's universal adult Covid-19 vaccination programme a success.
Things look a bit difficult, at least for now. But, thanks to a Supreme Court (SC) order, the mission mode approach of the government, including Modi’s outreach, will see India go a long way in Covid-19 vaccination, from the slow and rocky beginning since its launch.
The Plan
On June 26, a day before Mann Ki Baat, Manohar Agnani, Additional Secretary, Ministry of Health and Family Welfare, filed an affidavit in the Supreme Court to clarify certain issues that were flagged by the apex court while hearing a suo motu writ petition initiated on April 22, against the perceived mishandling of the second Covid wave by the Centre. The SC had raised questions about the Centre’s vaccine policy, procurement and distribution, role of private hospitals, differential pricing, logistics, etc, indicating possible lapses. In an order on May 31, the apex court flagged three broad issues — vaccine distribution among different age groups, the procurement process, and the augmentation of vaccine availability in India. The government’s current Covid-19 vaccination plan, as spelt out in the affidavit filed by Dr Agnani, attempts to address all such concerns by introducing a revised vaccine policy to augment availability, vaccinate all adults by the year end, and to centrally procure 75 per cent of the jabs produced in the country for free distribution to states.
Producing More
Lav Agarwal, Joint Secretary, Ministry of Health and Family Welfare, says India has come a long way in enhancing its production capacity of Covid-19 vaccines. “From 2.5-lakh doses of vaccines given in a day we have come to 41 lakh. Vaccine supplies have been enhanced by regular handholding with manufacturers in the last six months. The whole process of vaccine logistics management is also done almost in just-in-time approach,” he adds.
What Agarwal means is that through the Centre’s vaccination management system, one can identify how much vaccines are going to be produced, by when, and as soon as each batch is tested and cleared for use, it can be sent anywhere in advance, giving each state an idea about the number of doses expected in the next 15 days.
“We have been working with states to ensure that 75 per cent of vaccines produced in the country is available for free delivery to states. When such consistent efforts are being done to increase production, we should not be bogged down by daily targets. The target is to work with manufacturers and make sure we are able to cover the required population as early as possible,” says Agarwal.
The just-in-time approach, which means real-time shipping and near-time vaccination (of the same number) of 75 per cent of vaccines produced in India, gives us an idea of monthly production. Match that with the capacity claimed by companies and you will get an idea of how far India’s daily vaccination numbers can be pushed upwards. For instance, the Serum Institute of India says it can produce 6.5-crore doses of Covishield per month by July. Bharat Biotech International Ltd will have the capacity to produce 5.5-crore doses of Covaxin a month, also by July. Since these are the only Covid vaccines that have been administered in India till now (apart from the negligible doses of imported Russian Sputnik V), the combined production capacity of India — 12 crore a month — can only support the current level of vaccination — 40 lakh a day —and not the 90 lakh per day target to meet the December 31 deadline.
The only way to achieve scale is to enhance production capacities of these two firms and get more vaccines supplies — produced domestically as well as imported. The government’s hopes hinge on this mix. It expects 51.6-crore vaccines doses (of which 40 crore have been administered and another couple of crores of doses are in the distribution chain) to be available in the country by July end. While Covishield supply has been more or less on track, companies supplying Covaxin and Sputnik V have not yet delivered the committed volumes. Another 135-crore doses, with which the government expects to complete adult vaccination, are expected to be available between August and December. The break-up includes: Covishield (50 crore), Covaxin (40 crore), Sputnik V (10 crore) and two new vaccines — Bio E Sub Unit Vaccine (30 crore) and Zydus Cadila DNA Vaccine (5 crore).
Sputnik vaccines are currently being administered through private channels, and the process is expected to gain strength as local companies such as Panacea, Hetero, Gland, Virchow and others start fill-finish of imported bulk doses of Sputnik V in the coming months. While only 25 per cent of local production can be supplied to the private sector, there is no such quota restriction for imported vaccines.
The status of Biological E’s and Cadila’s Covid vaccines are also promising. In fact, the health ministry has paid Rs 1,500 crore in advance to Biological E for manufacturing and stockpiling 30-crore doses of its vaccine currently undergoing final Phase III clinical trials in India. Once the vaccine gets approval for emergency use, the government can use these reserved doses. Zydus’ vaccine is in a more advanced stage and the company has already applied for emergency use approval on the basis of very positive interim Phase III clinical trial data. Even though the government has not reserved any doses, Cadila is planning to stockpile for supply at short notice. “We are planning to scale up and produce up to 5-crore doses this year. We have already procured all the required (raw material) and made the upfront investment to be able to produce 10-crore doses a year. Now we will start discussions with the government to see if they are looking for the entire 5-crore doses or part of it (for 2021),” Sharvil Patel, Managing Director, Zydus Cadila, told Business Today.
In addition, the government is in talks with Pfizer and Moderna, the manufacturers of two new-generation (mRNA) vaccines to get their products available in India. To facilitate import, the Centre has also eased the approval process by allowing foreign vaccines approved by regulators such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) for restricted use in emergency situations in India without pre-approved clinical trials. Moderna has already secured an emergency use authorisation from the Indian drug regulator through its local partner Cipla. “I want to thank the Government of India for this authorisation, which marks an important step forward in the global fight against the pandemic,” Moderna CEO Stéphane Bancel said in a statement in June.
Pfizer is also getting necessary clearances done. In a video statement, in May, Pfizer CEO and President Albert Bourla said the company is aware that access to vaccine is critical in the fight against the pandemic. “Unfortunately our vaccine is not registered in India, although our application was submitted months ago. We are currently discussing with the Indian government and expedite the approval to make Pfizer-Biontech vaccine available in the country,” Bourla had said. Both Moderna and Pfizer vaccines could also reach India through the COVAX facility, a global risk-sharing mechanism for pooled procurement and equitable distribution of Covid-19 vaccine.
Anticipating more supply of vaccines in the coming months, the government has set up two vaccine testing facilities at its autonomous research institutes — the National Centre for Cell Science (NCCS), Pune, and the National Institute of Animal Biotechnology (NIAB), Hyderabad — as the Central Drug Laboratory (CDL) for batch testing and quality control of vaccines. This will remove a major bottleneck as so far every batch of vaccine, imported or locally made, were getting tested from CDL in Kasauli, Himachal Pradesh, the only national laboratory for testing and pre-release certification of vaccines meant for human use in India.
Delivery Challenges
One of the recurring questions health ministry officials face during their Covid-19 press briefings week after week is the issue of non-availability of vaccines in some parts of the country or the other. Officials have been defending their position by saying that vaccine availability is not the problem, it is the planning that takes place at the micro level. They have always maintained that once sufficient volumes are made available, vaccination, at least in government centres, will turn smooth. But that alone is unlikely to suffice. Approximately, 55 per cent of India’s population is serviced by private hospitals, and the 25 per cent of Covid-19 vaccine doses that private channels can access and administer (at pre-fixed charges) should also function smoothly for the vaccination programme to be a success. “I urge the vaccine availability in the private sector to be utilised optimally. We should encourage people and also help them to seek vaccines from private channels as well,” says Dr V.K. Paul, Chairman, National Task Force on Covid-19, and Member, NITI Aayog. Unfortunately, private hospitals, apart from a few large ones, are yet to lay their hands on vaccine doses.
What troubled private hospitals most were frequent changes in sourcing procedures. While private hospitals were roped in to vaccinate the most vulnerable segments, including frontline workers, doctors and other employees in the healthcare profession during the Central government-controlled first stage of the vaccination process, they were asked to source vaccines directly from manufacturers in the second stage. “The government had announced that the private sector will be procuring 25 per cent (of the total production) directly from manufacturers from May 1. Soon, bigger groups, which had the money — the likes of Apollo, Max and Manipal — were smart enough to place orders with Serum, which was also happy because it was supplying bulk quantity at one place. In the process, smaller hospitals did not get any vaccine. So, in May and June none of the private hospitals were able to vaccinate, except some 15-20, in addition to the bigger ones,” says Dr. Girdhar Gyani, Director-general, Association of Healthcare Providers of India (AHPI).
Gyani’s organisation, which has a membership of 11,000 hospitals, including 2,900 with more than 100 beds, took up the matter with the vaccine manufacturer and submitted a collective demand from some 750 hospitals for around 30-lakh doses. “Serum picked 28 hospitals from the list — mostly in North-East and Eastern India — and said they will supply 3,000 vaccines each to these hospitals. Seven hospitals paid as well. In the meantime, the government issued a circular, which said that private hospitals will have to route their requirement through state governments. Serum supplied vaccines to only those hospitals that had paid the money. After the order of routing through state governments came in force from June 21, till July 4, when I last checked, no hospital has been given any confirmation by respective states. Forget about supply, they have not been given even the confirmation that should come from the government/district medical officer. Even these officials are not very clear how it is going to happen. So, there is a big confusion,” says Gyani. AHPI also tried to generate bulk orders for member hospitals from foreign vaccine manufacturers such as J&J, but that is also work in progress.
Siddhartha Bhattacharya Secretary-general, Healthcare Federation of India (Nathealth), a group representing the healthcare industry, including hospitals, is more optimistic. “The numbers suggest that at least in urban and semi-urban areas, the supply situation has improved. As the supply situation improves, on the private sector side, the uptick is also going to improve and will grow closer to 25 per cent. We are heading in that direction. With at least three or four more vaccines in the pipeline, Covid-19 vaccines are going to be available on the tap,” he says.
Hurdles On The Way
A survey conducted by community social media platform LocalCircles in June among the unvaccinated population showed that only 29 per cent of the 8,949 respondents were willing to take the vaccine soon, and 24 per cent would take it only if they are convinced about the efficacy or if more vaccines become available.
“Approximately 30 per cent of the adult population is hesitant to take vaccines. At least in Delhi, one can sense that from the crowd at the vaccination centres. If you consider the hesitancy part, and take out the 30 per cent who will not go for vaccination anyway, the rest of the adult population will be vaccinated by December 31,” says Gyani of AHPI.
Even if India does achieve what Gyani predicts, its positive impact on the country’s economy may be significant. Nomura Research says it expects enough supply to fully inoculate about 50 per cent of the total population (around 70 per cent of the adult population) by 2021 end. “Achieving this vaccine pivot point remains crucial to supporting the nascent recovery, especially with emerging concerns of a third wave and a new delta plus variant 2,” Nomura economists said in an investor note on June 24.
Massive infections and hospitalisation of children if a third wave happens can delay the fight. That may even compel the government to drop plans of adult vaccination using Zydus Cadila vaccine (the only vaccine currently being tested for the 12-18 age bracket) and instead open up vaccinations for that age group as well. An alternate would be to give advance purchase orders for children’s vaccines from manufacturers within and outside India. With 35-40 crore children in that age group, advance orders could mean that some of the large manufacturers would want to expedite clinical trials in India. Many countries did it for adult doses and were able to vaccinate bulk of their population before others. India missed that opportunity. Perhaps it can make sure that there is no vaccine shortage as and when the country readies for universal Covid-19 vaccination.
So, the country could miss the December 31 vaccination deadline, but by then the juggernaut would have begun rolling for sure.
@joecmathew
