The following is the second part of a two-part analysis by Neeta Sanghi. Read the first here (‘How the Modi Government Overestimated India’s Capacity to Make COVID Vaccines’).
Prime Minister Narendra Modi announced earlier this month that people older than 18 years would be eligible to receive Covaxin or Covishield, India’s vaccines against COVID-19, from May 1. As heartening as this sounds, multiple points of concern, many of them subtle, undercut this announcement to the extent that they could render the Indian government’s words empty.
Their existence also raises doubts about whether the government is aware of their existence, and if so, what it plans to do to manage their implications for India’s already flagging vaccination drive.
Until April 22, 132.8 million doses of COVID-19 vaccines had been administered in India, according to the Co-Win dashboard. A little over 8% of the Indian population had received at least one dose and 1.4% had received both doses. With a population of 1.38 billion, India needs a very large number of doses to achieve vaccine-induced herd immunity, and that in itself may not suffice to quell the epidemic.
India commenced its vaccination drive on January 16, 2021, with a target to vaccinate 30 million frontline workers by March 31. Earlier that month, regulatory authorities had provided accelerated approvals for two vaccines – Covishield, made by Serum Institute of India (SII), and Covaxin, made by Bharat Biotech. The government decided to bear the full costs of the vaccination of frontline workers.
However, Times of India reported on April 19 that only 37% of the 30 million frontline workers had received both doses (of either vaccine), and an additional 30% had received only the first dose. Vaccine hesitancy – manifest in the form of fewer than 80% of eligible frontline workers having registered to be vaccinated – and diversion of vaccine doses to people eligible under the second phase from March 1 are possible explanations for this underperformance.
In the last week of February, the Centre announced the start of the second phase, in which people older than 60 years and those older than 45 years with comorbidities would become eligible to be vaccinated, from March 1. It allowed a few private hospitals to provide vaccination services in order to increase the pace of the drive. The people had a choice: to visit a government hospital for free vaccination or a private hospital for Rs 250 per dose.
In parallel, the number of COVID-19 cases began to increase in February; by March 20, India was reporting around 40,000 new cases a day, with the surge concentrated in a few states. At this time, Union health minister Harsh Vardhan categorically ruled out the need for “universal immunisation”. Nevertheless, just a few days later, the government decided to extend the vaccination drive in a third phase to include all above 45 years of age, effective April 1.
Vinod K. Paul, a member of NITI Aayog and chairperson of India’s COVID-19 task force, expressed confidence that the public delivery system was robust enough for the task and that the government had adequate supplies. And although the B.1.1.7, B.1.351 and P.1 strains of the virus had been found among Indian samples, Paul was sure that extending the vaccination to include all above 45 years would ensure coverage of India’s high-risk populations.
The number of daily vaccinations crossed a million in the first week of March and showed an upward trend throughout the month. As the third phase, which included everyone older than 45, opened on April 1, there was a big jump on the first day, when over 3.5 million doses were administered. The daily vaccination number touched a high of 4.5 million doses on April 5 – but since then, the number has only been falling, thanks to vaccine shortages.
A cascade of shortages
On average, SII produces 60-70 million doses of Covishield a month and Bharat Biotech, some 5 million doses of Covaxin a month. So with a daily production average of just 2.5 million doses, a vaccination rate higher than this number is obviously unsustainable.
Maharashtra, Punjab and Odisha, among others, started complaining of shortages first, followed by others. Social media, TV channels and news portals highlighted multiple instances of centres being temporarily closed due to a dearth of vaccines, including in states ruled by the Bharatiya Janata Party, like Uttar Pradesh.
As is its wont, the government vehemently denied any shortage at first. But when the paucity became hard to deny, it took some steps to address shortages and enhance production, especially this month.
At the same time, the number of new daily cases has been rising rapidly – crossing 1 lakh on April 1, 2 lakh on April 14 and 3 lakh on April 21. Notice that the time taken for the second lakh was two weeks and for the third, one week. The virus also appears to be spreading faster and, according to anecdotal reports by medical practitioners, is affecting “paediatric to geriatric” people.
In this scenario, many states wanted flexibility in vaccine procurement and to decide who could be vaccinated.
On April 19, the government announced that the drive would be opened up to everyone older than 18 years from May 1. This “liberalised and accelerated phase 3 strategy” has accompanied some other measures that the government expects to calm anxieties about vaccine availability and, ostensibly, to provide more flexibility to states on pricing, procurement, eligibility and administration.
However, the new strategy shifts the responsibility for vaccinating people younger than 45 years to state governments, while still requiring vaccine manufacturers to give half of their output to the Centre.
The manufacturers will be free to negotiate their prices and sell a corresponding amount to state governments and private entities. To this end, they have also received financial support from the Centre and have in turn promised to increase supplies as soon as possible.
Remember at this point that SII is required to share at least half of its production with other countries — an obligation that it has been defaulting on for the last month or so. At some point in the near future, it will have to meet it, thus reducing the quantity available for India.
State governments as well as private entities can import foreign vaccines, once the regulators have approved them, directly — and a couple are on the horizon. Sputnik V, imported by Dr Reddy’s from Russia, may be available by May/June in small quantities to begin with. In another welcome move, Pfizer has offered vaccines on a no-profit basis for the Indian market.
However, the chance of sufficient increase in supplies within the next couple months – either from indigenous manufacturers or through imports – is not very high. The government will of course continue vaccinating people older than 45 years according to its prior strategy. It has also said it will prioritise people who have received one dose and are waiting for the second.
From May 1, around 60% of the population, some 840 million people, will become eligible to receive the vaccines. That this comes at a time when most of those older than 45 years have yet to be vaccinated, when there is an acute shortage of vaccines and when the virus is spreading faster than wildfire could create a perfect storm of chaos across the country, as people scramble to get their shots.
In numbers: 1.68 billion doses are required to vaccinate all adults in India. At current production levels, this will require 22 months, up to February 2023, to achieve. Even 70% coverage, related to the notion of herd immunity (notwithstanding its limited usefulness to containing the epidemic), will take up to August 2022. These numbers don’t include children, who will have to be included as and when safe, efficacious vaccines are available for them.
Another point of complexity is that people older than 45 years – 18.3% of the population – still require 371 million doses for full coverage. This in itself will consume the full production from both SII and Bharat Biotech for the next five months, until September 2021.
Note also that vaccine manufacturers are likely to prioritise this part of the drive over the demands of state governments and private hospitals because it’s a wholly Central government initiative. This in turn could effectively scuttle any efforts by the states to procure the vaccines for those younger than 45 years in the next one to two months.
So although the Indian government has announced that all people older than 18 years can start getting vaccinated from May 1, it hasn’t given the states sufficient time to procure stocks for this exercise.
The Centre’s plan for now seems to be to have multiple entities vie for the same vaccines – already in short supply – amid a sudden, sharp increase in demand, in a wider environment of desperation, all likely on the path of a price war whose sole beneficiaries are likely to be the vaccine manufacturers.
We shouldn’t be surprised if there’s a black market in vaccines the way there is already one for repurposed antiviral drugs like remdesivir. And just like the manufacturers are likely to win big, India’s poorer people are likely to lose big, as doses become concentrated in the hands of those who want it instead of those who need it. Such an outcome, which the Centre’s announcement supports, lies 180º from the government’s stated aim earlier this month.
The money problem
Funds to procure the vaccines pose another challenge for state governments. In the 2020-2021 Union budget, finance minister Nirmala Sitharaman said the government would allocate Rs 35,000 crore for the COVID-19 vaccination programme. T.V. Somanathan, the expenditure secretary in the finance ministry, has also said that this amount will cover the full cost of vaccinating 500 million Indians.
Aside from the prospect of a price war, vaccine expert and Christian Medical College professor Gagandeep Kang has provided another compelling reason to rethink making vaccines available for purchase in the free market. She has contended that the vaccines still only have ‘restricted’ or ’emergency use’ licenses, based on which the extent to which their safety and effectiveness has been assessed, as well as that no other country (except perhaps Russia) has allowed such vaccines to be sold on the free market.
Indian states’ health infrastructure is already crumbling under the increasing COVID-19 load. In these circumstances, expecting the state governments to manage the vaccination of people belonging to two different age groups via two independent processes of procurement and distribution is unreasonable.
States ruled by opposition parties have already criticised the government and accused it of abdicating its responsibilities. Even if one were to discount this to some extent as being politics as usual, the actions of the government do beg the question: how serious is it really about vaccinating Indians?
It’s inexplicable that in the second half of 2020, when countries in the west were scrambling to order vaccines for their people, the Indian government neither demonstrated the same urgency in booking capacities with manufacturers for potential vaccines nor discussed ways to enhance capacities in any meaningful way.
Throughout the COVID-19 crisis, in fact, the Government of India has exhibited a complacency on the back of its mistaken belief that India’s vaccine needs can be met by the indigenously manufactured vaccines alone.
With the novel coronavirus’s spread attaining frightening proportions in the country, the government has finally decided to hand over the responsibility of vaccinating young Indians to the states while hoarding all the power for itself. In effect, its latest announcement, in its big-bang approach and lack of thoughtful preparedness, is only reminiscent of Modi’s demonetisation and complete lockdown announcements in 2016 and 2020.
This isn’t to say that the Centre has a magic wand and can just order shots for all Indian arms – but it should make amends for its errors of governance in the last few months at least. Nothing else can improve our current situation.
First, the government should assume responsibility, along with the states, for vaccinating Indians. It should source vaccine supplies for India with a degree of urgency beyond what it has displayed thus far, and negotiate rates and quantities with potential suppliers. It should remember at all times that its word will carry far more heft with a manufacturer than that of any state government.
(Negotiations with Pfizer may be a good place to start since the company has already demonstrated its willingness to sell its vaccine in India.)
Second, the Centre should leave the details of the actual delivery schedule to a coordination panel comprising officials from the Centre and states. This panel should allocate the available stock equitably and transparently. The Centre should also monitor the panel’s activities, probe allegations of bias and nip these and similar problems in the bud.
Third, the government should step up to bear, say, half the purchase price for all vaccines intended for people younger than 45 years. The remaining half should be borne either by the state government or passed on to the people – a decision to be left to the states.
Overall, the Government of India should fairly treat – and should be seen to fairly treat – all state governments simply because that’s what India deserves at this time.
Neeta Sanghi has over three decades’ experience in managing pharmaceutical supply chains. She is currently working on a book about the industry.