ARJUN KANG JOSEPH
WHAT IS THE STATE OF INDIA’S VACCINATION PROGRAM AS OF MAY 2021?
In October 2020, India’s minister of health and family welfare announced that the government planned to receive and use 400 to 500 million COVID-19 vaccine doses to cover 200 to 250 million people by the end of July 2021. As of May 16, 2021, India had reported administering 182 million COVID-19 vaccine doses, and 41.6 million people in India had received both doses of the vaccine. The original target appears to have been revised, as Indian Prime Minister Narendra Modi mentioned a vaccination target of 300 million people (which means 600 million doses)—focusing primarily on the elderly and those with comorbidities—during his address at the World Economic Forum’s Davos Dialogue earlier this year. As things stand, India is likely to fall short of either target.
The biggest cause for concern at the moment is the rapidly dropping vaccination rate. India began vaccinating its population on January 16, 2021. But the country has gone from a daily average of 3.65 million doses being administered from April 1 to April 10 to an average of 1.8 million doses a day in the month of May (calculated using data from the Ministry of Health and Family Welfare’s Cumulative Coverage Reports of COVID-19 Vaccination from May 1–16).
At the current rate of vaccination, India will only have given approximately 322 million doses of COVID-19 vaccines by the end of July 2021, according to my calculations. The drop in the vaccination rate can be directly attributed to the dwindling supply of vaccines.
The two main vaccine manufacturers, Serum Institute of India (SII), which makes Covishield (a local version of the Oxford-AstraZeneca vaccine), and Bharat Biotech, which makes Covaxin (an indigenously developed vaccine), have struggled to meet domestic and global demand. SII currently manufactures 65 million doses per month while Bharat Biotech manufactures 20 million doses per month. Both manufacturers had sought grants of approximately $400 million and $210 million respectively from the Indian government to increase production capabilities. The government granted these funds in the form of an advance payment for vaccines to be supplied in the coming months. However, the decision to do so was made in April 2021, when India had already been hit by the second wave. SII and Bharat Biotech claim that they will be able to produce 100 million doses per month and 78.2 million doses per month respectively starting in August 2021. But even if both companies succeed in meeting their production targets, it is important to remember that a portion of these doses will be used to fulfil their international commitments as well.
India has also granted emergency use authorization to a third vaccine, Russia’s Sputnik V vaccine, of which 210,000 doses have already arrived in the country. Dr. Reddy’s Laboratories is the Indian partner that conducted the clinical trials and holds the distribution rights for the vaccine in India. The Russian Direct Investment Fund has also signed manufacturing partnerships with five local companies, with the aim of producing 50 million doses per month.
Another, and perhaps greater, threat that vaccine manufacturers in India face is constraints on the supply of several components—such as the sterile single-use containers in which the vaccine cells are grown—that are crucial to produce vaccines. These constraints were brought about in part by measures taken by U.S. President Joe Biden’s administration to ensure the United States’ own public health supply chains. These restrictions have reportedly halved the number of doses of Covovax (which is SSI’s version of Novavax’s NVX-CoV2373 vaccine) that the institute can stockpile and may limit its ability to increase capacity to manufacture Covishield. Bharat Biotech’s chairman and managing director has also remarked that the restrictions have impacted supply chain logistics. India has taken this up with the Biden administration, which has promised to give the matter due consideration.
Given the vaccine supply crunch, India’s Vaccine Maitri initiative—under which the government provided vaccines manufactured in India to the world—has drawn significant criticism. India has distributed over 66.3 million doses of vaccines to ninety-five countries, either as aid or under commercial contracts. Approximately 10.7 million doses have been donated as aid, out of which 7.85 million doses were donated to India’s neighbours and 200,000 were given to UN Peacekeeping forces. A spokesperson for the ruling Bharatiya Janata Party (BJP) further clarified that 55 million doses were donated as part of SII and Bharat Biotech’s commercial and licensing liabilities.
One such liability is SII’s agreement with Gavi, the Vaccine Alliance, a public-private global health partnership with the goal of increasing access to immunization in poor countries. Under the terms of the deal, which was signed last year, Gavi provided funds that helped SII set up production facilities. In return, SII agreed to supply 200 million doses of vaccines to COVAX (a global collaboration that aims to accelerate the development and manufacture of COVID-19 vaccines and to guarantee fair and equitable access for every country in the world). SII was expected to deliver the first 100 million doses to COVAX by the end of May but reportedly has so far only delivered 30 million doses (including 10 million earmarked for India under COVAX).
HOW HAS THE GOVERNMENT DETERMINED WHO WILL GET THE VACCINE AND WHEN?
India’s national COVID-19 vaccine strategy was built on a systematic and scientific approach that prioritized the vaccination of more vulnerable or high-risk groups, according to the central government’s Ministry of Health and Family Welfare. The vaccination program has had three phases.
The first phase, which began on January 16, 2021, focused on vaccinating healthcare and frontline workers.
The second phase, starting on March 1, 2021, consisted of two parts. During the first part, people over the age of sixty and those above age forty-five with specific comorbidities were vaccinated. On April 1, 2021, the government decided to expand eligibility to everyone over the age of forty-five.
The third phase began on May 1, 2021, when anyone over the age of eighteen was eligible to get vaccinated. The vaccination numbers, as of May 15, 2021, are below.
Category First Dose Second DoseHealthcare Workers 9,642,077 6,640,753
Frontline Workers 14,423,966 8,186,165
People aged 60+ 54,467,664 17,798,573
People between the ages of 45 and 59 57,155,909 9,063,011
People between the ages of 18 and 44 4,821,550 -
While several other countries have followed a similar approach of prioritizing vulnerable groups, few have implemented it on the massive scale India requires. The decision to begin the third phase of the vaccine strategy seems to have been made to increase vaccination numbers. However, this has tripled the demand for doses, with 500 to 600 million people being added to the already eligible pool of 300 million and, thereby, further contributing to the vaccine shortfall.
WHO WILL SUPPLY VACCINES AND WHAT ADVANCE PURCHASE COMMITMENTS HAS THE INDIAN GOVERNMENT MADE TO DATE?
During the first two phases of the vaccination program, the central government was solely responsible for procuring doses of Covishield and Covaxin from the two Indian vaccine manufacturers SII and Bharat Biotech.
Ten days prior to the beginning of the third phase, the government released a new Liberalised Pricing and Accelerated National Covid-19 Vaccination Strategy. According to this strategy, vaccine manufacturers were expected to supply 50 percent of the doses they produced directly to the central government. These doses would continue to be used for the vaccination of healthcare workers, frontline workers, and people over the age of forty-five.
Vaccine manufacturers are free to sell the remaining 50 percent of doses directly to state governments, private hospitals, and industry at a pre-declared price.
Following media reports that the central government hadn’t placed fresh orders for vaccines since March 2021, when they ordered 100 million doses of Covishield from SII and 20 million doses of Covaxin from Bharat Biotech, the Ministry of Health and Family Welfare clarified that this was not the case. It said the government had made advance purchase orders on April 28, 2021 for 110 million doses of Covishield and 50 million doses of Covaxin, and that these doses would be delivered between May and July 2021. However, of the total 120 million doses ordered in March 2021, approximately 12.6 million doses of Covishield and 11.2 million doses of Covaxin from the order in March were yet to be delivered.
Even at the current lower rate of vaccination (1.8 million doses per day), the vaccines yet to be delivered would run out by the end of August once deployed. As discussed above, although SII and Bharat Biotech have received advance payments for more doses, it is unclear whether any further orders have been officially placed.
WHAT IS THE DIVISION OF RESPONSIBILITY BETWEEN THE CENTRAL GOVERNMENT AND STATES?
India’s central government has said that it is responsible for the vaccination of healthcare workers, frontline workers, and people over the age of forty-five. The central government provides these vaccines free of cost and the funds to pay for these vaccinations comes from the $4.8 billion the government previously allocated for the COVID-19 vaccine.
In April 2021, the central government announced that the states would be responsible for procuring vaccines for the eighteen-to-forty-five-year-old age group and that the prices for procurement would be pre-declared by the vaccine manufacturers themselves. The Indian central government’s decision to decentralize vaccine procurement and liberalize pricing was extremely controversial, especially in the face of a supply crunch.
The decision to decentralize vaccine procurement shifts the onus for vaccinating the population between eighteen and forty-five years old onto the states. In addition to making the states responsible for procuring the vaccines, states will have to pay higher prices than the central government (which pays approximately $2 per dose). SII has said it will sell Covishield to state governments and private hospitals at rates of approximately $4 and $8 respectively. Correspondingly, Bharat Biotech will sell Covaxin at the rates of $8 and $16. In spite of this, at least twenty-four state governments have decided to carry out free vaccinations. However, this places a tremendous financial burden on the state governments and in some cases may require them to spend up to 30 percent of their health budgets. The states also have to compete with the private sector to procure doses from domestic manufacturers.
Many states have been unable to begin their vaccination drives for the eighteen-to-forty-five-year-old age group because they have not been able to secure a supply of doses from Indian manufacturers. Thus far, at least twelve states have floated global tenders for additional doses of COVID-19 vaccines. Some states have run into some issues with the global tenders for vaccines that haven’t been approved by the central government. However, the central government did agree to fast-track approvals for vaccines that have been granted emergency approval for restricted use by the United States Food and Drug Administration, European Medicines Agency, UK Medicines and Healthcare Products Regulatory Agency, or the Pharmaceuticals and Medical Devices Agency in Japan or that are listed in the World Health Organization’s Emergency Use Listing. This move will allow more vaccines to come into the market, thereby easing the supply crunch, to an extent. The importer or local partner for the vaccine will still need to follow India’s Central Drugs Standard Control Organisation (CDSCO) guidelines in order to gain approval from the Drug Controller General of India.
However, as various state governments are navigating this complex process and how to fund it, it is unlikely that fast-tracking the approval of vaccines will completely alleviate the current supply crunch. Many states and officials have argued that centralized procurement of vaccines is necessary.
HOW ARE CITIZENS LOCATING VACCINES AND WHAT CHALLENGES ARE THEY FACING IN DOING SO?
The Indian government requires citizens over the age of eighteen to register themselves before they can be vaccinated. They have been provided the option of registering though the CoWIN website (a platform created to monitor vaccine delivery) or the Aarogya Setu app (a government-sponsored mobile application originally created for contact tracing that now also allows vaccine registration). After verifying their mobile numbers, citizens need to supply basic details such as their name, age, and photo identification. Once citizens are registered, they can search for vaccination centers based on postal codes and schedule an appointment at the most convenient location.
On April 28—the day when registration was opened for the eighteen-to-forty-five-year-old age group—people faced issues receiving one-time passwords required for the process, and shortly afterward, the servers crashed. In spite of the servers being quickly brought back online, many people could not schedule appointments as there were no slots for the eighteen-to-forty-five-year-old age group. Reports indicated that even if they managed to schedule appointments, many received notifications about cancellation of their booking slots, while others were turned away when clinics ran out of vaccines.
As things stand, there are two significant problems with this system of vaccine registration. First, it fails to consider that much of India’s population does not have access to digital services. Second, the online portal is in English. Given that only a small percentage of Indians can speak, read, and write English, that close to half the Indian population lacks internet access, and that only 20 percent of those who have access can use digital services, this is an important obstacle.
The Supreme Court took notice of this issue and questioned the central government’s decision to require online registration on the grounds that this may violate citizens’ fundamental rights. The central government responded that, in light of prevailing conditions, the registration requirement was an administrative necessity and that these citizens could register themselves with help from family, friends, nongovernmental organizations, and common service centers (which are access points for the delivery of essential public utilities, welfare schemes, and other services in rural areas). But in effect, this potentially excludes a large segment of the population and defers the responsibility onto other citizens.
WHAT ROLE DOES THE PRIVATE SECTOR PLAY, INCLUDING IN TERMS OF IMPORTING FOREIGN-MADE VACCINES?
The Indian government has allowed the private sector to procure vaccines directly from manufacturers. More importantly, they have allowed the private sector to import vaccines from other countries, as long as they follow the CDSCO guidelines and obtain an import license. These imports will have to take place based on the guidelines of the Liberalized Pricing and Accelerated National COVID-19 Vaccination Strategy.
For vaccines that have not been approved or licensed in India, either the importer (an Indian subsidiary) or the authorized agent of a foreign manufacturer is required to obtain three permissions or licenses from the CDSCO. These were welcome steps in the face of a vaccine supply-crunch.
The first foreign-manufactured vaccine to be approved in this way was Russia’s Sputnik V vaccine. The Indian pharmaceutical company Dr. Reddy’s Laboratories possesses distribution rights for the Russian vaccine in India and has applied for the permissions and licenses required to distribute the vaccine. About 210,000 of the total 250 million doses that Dr. Reddy’s plans to import from Russia have already arrived in India. The Russian Direct Investment Fund has signed a manufacturing pact with five Indian companies and has plans to gradually increase production to 850 million doses of the vaccine annually.
On the ground, smaller private hospitals have had difficulty competing with state governments and larger hospital chains for the available pool of domestically manufactured vaccines. It is likely that these private players will have to explore other options, such as foreign manufacturers, in order to procure vaccine doses. Critics of the decision to decentralize procurement and liberalize pricing have said that the policy enables a small group of hospitals to profit and will likely hamper universal vaccination.
WHAT ARE THE BEST ESTIMATES OF VACCINE TIMELINES?
At the current rate of vaccinations, India has a long road ahead. Rough calculations show that in order to vaccinate 945 million adult citizens, India will require 1.89 billion doses in total. At the current vaccination rate, it may take up to three years to vaccinate this population.
At a recent press conference, Vinod K Paul, a member of NITI Aayog (a central government think tank) stated that the government expects 2.16 billion doses to be produced between August and December. This expectation is ambitious as it is contingent on the successful completion of clinical trials and regulatory approval for five different vaccines. Below is a table summarizing the current state of vaccines in development in India.
Vaccine Developer/Manufacturer StatusZyCoV-D (second indigenously developed vaccine) Zydus Cadila Supply is likely to begin in June 2021
Covovax (SSI’s version of NVX-CoV2373) Developed by Novavax (USA) and manufactured by SSI The companies entered into an agreement in August 2020 and SSI is expected to test the safety of Covovax. The institute intends to begin stockpiling in April and is targeting production to reach upwards of 40 to 50 million doses per month.
Biological E Limited vaccine Biological E. The company is set to launch Phase III clinical trials after being granted approval from the CDSCO Subject Expert Committee.
HCGO19 Gennova Biopharmaceuticals The Department of Biotechnology in Ministry of Science & Technology announced in April 2021 that it has approved additional funding toward clinical studies of India’s “first of its kind” mRNA-based COVID-19 vaccine.
BBV154 Bharat Biotech The intranasal vaccine is currently undergoing Phase I trials in the cities of Patna, Chennai, Hyderabad, and Nagpur.
UB-612 Aurobindo Pharma in an agreement with COVAXX (USA) The collaboration expects to submit clinical trial data in July 2021 and expects approval within the financial year.
Of these 2.16 billion doses, 1.46 billion are expected to come from SII, Bharat Biotech, and the six companies that manufacture the Sputnik V vaccine. Additionally, three public sector companies are now allowed to produce Covaxin. This does not account for potential vaccine imports from foreign companies like Pfizer, Moderna, and Johnson & Johnson. The Indian Department of Biotechnology and Ministry of External Affairs have reportedly been in talks with foreign manufacturers. Thus far, an agreement has only been reached with Johnson & Johnson.
WHAT ROLE IS THE INTERNATIONAL COMMUNITY PLAYING IN GETTING INDIANS ADEQUATELY VACCINATED?
India has received significant aid from the international community, in terms of oxygen and other essential supplies. But it has not received vaccines from other countries, except Russia. Russia has also announced free technology transfer and financial support for capital expenditure to its COVID-19 vaccine manufacturing partners in countries including India.
India has technically received 10 million doses of vaccines from COVAX, but these doses are a part of the 200 million doses SII had previously committed to COVAX. The funds SII received under this agreement provided them the initial capital to scale up Covishield production.
The United States can potentially play a significant role in ensuring that Indians get adequately vaccinated in two ways. The first is with regards to the surplus 60 million doses of the AstraZeneca vaccine that the United States has committed to donating to other countries. India reportedly expects to receive a considerable share of this stockpile. The second is to remove or create exceptions to measures (imposed by the United States Defense Production Act) requiring manufacturers registered in the United States to prioritize supplies for their domestic market, thereby enabling the supply of products and raw materials essential for vaccine manufacturers to produce in countries like India.
When it has been able to, India has provided aid to other countries. That, along with the fact that efforts like COVAX expect supplies of vaccines from India (which are delayed due to excess local demand) should be reason enough for the international community to play a more active role in ensuring that Indians get adequately vaccinated. Any action to boost manufacturing of vaccines or bump vaccine supply by sending surplus doses to India will in turn benefit the rest of the globe.
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