IndiaSpend unpacks the infrastructural and administrative issues that may arise for a COVID-19 vaccination plan; and the tension between the child vaccine programme and a mass adult vaccination effort. (Read our complete coverage of the COVID-19 pandemic here).
India’s vaccine infrastructure
India’s Universal Immunisation
Programme (UIP) targets 26.7 million newborns and 29 million pregnant women every year (55 million people in total, or 4% of the total population), with about 390 million doses of vaccines, over nine million sessions. To administer 400 to 500 million doses of a COVID-19 vaccine by the first two quarters of 2021, India will have to nearly double the total number of vaccinations given in the public sector programme.
This will entail ramping up capacity to administer vaccines, including the vaccine cold-chain (infrastructure and process of storing and transporting vaccines safely) and logistics, ancillary items such as syringes and glass vials, and training of healthcare workers. Without this, even if there is a life-saving vaccine available for COVID-19, people will not be able to access it.
Government runs vaccine cold chain, little private role
While private players make most vaccines, the entire cold-chain for India’s child immunisation
programme is publicly funded and managed, with few ‘Made In India’ contributions by private companies. This could prove costly for a COVID-19 immunisation programme.
A lot of India’s existing walk-in freezers and coolers that are part of the cold chain have been imported from Danish companies, said Prabir Chatterjee, a public health professional who worked to implement India’s vaccine programme with both the United Nations Children's Fund (UNICEF) and the World Health Organization (WHO).
“A major part of India’s vaccine programme has been triggered, funded and thus designed by foreign organisations like UNICEF, WHO and GAVI, the Vaccine Alliance. A few European companies were the only ones who met UNICEF’s standards for equipment and are thus the only ones who’s machines were installed in the UIP under supervision of these agencies. Hence, there has been a very little role for Indian companies in supplying hardware or servicing the cold chain,” Chatterjee told IndiaSpend.
This dependence on foreign companies at the expense of Indian ones parallels what has happened with the availability of ventilators and personal protective equipment (PPE) in India. The shortage of ventilators and PPE was met by imports until a massive effort by the government and private companies began to design, test, manufacture and sell these items domestically. Various news
reports have highlighted that some of these hurriedly-made ventilators and PPE have proved faulty.
Currently, the UIP has over 27,000 cold-chain points and 76,000 items of cold-chain equipment, with 95% located in primary health centres, community health centres and sub-centres. There are also 55,000 staff to run the cold-chain, according to government data. By 2014, the government added five new vaccinations to the basket of routine vaccines, and had to ramp up cold-chain equipment. By 2017, 28,340 new items of cold-chain equipment were purchased for vaccines. The cold chain will be vital to the new COVID-19 vaccine too.
“There is some spare capacity in the existing cold-chain network because India has been scaling back its polio vaccinations,” Gagandeep Kang, member of the WHO’s working group on COVID-19 vaccines, told IndiaSpend.
“But for 500 million COVID-19 vaccines which the Indian government is talking about, we don’t even know yet whether there will be those many doses available to India, and who the priority groups are who will need it. Only when the government discloses this, can we look into whether India’s existing cold chain capacity is really enough,” said Kang.
IndiaSpend has reached out to the Ministry of Health and Family Welfare (MoHFW), Indian Council of Medical Research and NITI Aayog for comment. We will update this copy when we receive a response.
Most vaccines provided under India’s government programmes are stored at 2°C to 8°C in the cold chain (except polio and rotavirus vaccines). Some of the current COVID-19 vaccine candidates, such as those from AstraZeneca/Oxford, Johnson and Johnson and Novavax, will also be stored in the same temperature range. The vaccines being tested by MNCs including Moderna and Pfizer, however, will need to be stored at sub-zero temperatures. If such vaccine candidates emerge as optimal, India’s cold chain will not be able to stock them without affecting the existing children’s vaccines.
Syringes and vials
“Selling vaccines in India is like selling traffic lights--the government is the primary or only client,” Rajiv Nath, managing director, Hindustan Syringes and Medical Devices Limited (HMD), and coordinator of the Association of Indian Manufacturers of Medical Devices, told IndiaSpend.
In May, American philanthropist Bill Gates told the media he was worried that a shortage of specialised glass vials used to store vaccines could hinder vaccine delivery worldwide (the Gates foundation plans to spend over $350 million (Rs 2,560 crore) on its COVID-19 response, including accelerating the development of vaccines).
So far, no public tender has been put out by India’s government for procuring syringes and glass vials for a potential COVID-19 vaccine. Companies that supply these to the government also say they have not yet been contacted for orders. This could trigger a scramble, much like the scramble for PPE, ventilators and drugs like remdesevir which IndiaSpend reported on in July.
HMD currently supplies millions of syringes to the government’s vaccine programme, Nath says, adding that the lack of surety from the Indian government “is putting [HMD] in a tricky situation.”
First, Nath explained, if Indian companies are required to massively ramp up production, they will need to import new equipment (unlike with stitching extra PPE, where regular garment companies could be repurposed). For this, syringe and vial companies need a commitment from the Indian government that their stocks will be bought up. Millions of syringes ordered by the government from HMD for this year’s routine immunisation programme are still lying uncollected and have not been paid for, Nath alleged. (Hundreds of thousands of children missed their vaccine shots in March and April, IndiaSpend reported in August based on government data.)
Second, Nath said, if the Indian government does not stockpile vaccination equipment well in advance, they may instead suddenly ban exports later, as they did for PPE, face masks and sanitisers, as IndiaSpend reported in June. This would mean that Indian manufacturers like HMD will not be able to sell such items abroad and meet global needs either.
“We think governments should work with companies in peace-time, not in war-time,” Prashant Amin, managing director of Borosil Klasspack, which makes glass vials for vaccines, told IndiaSpend. “It will be a really sorry state if the vaccine is ready, but the supply chain is not.”
It is not enough to develop a working vaccine in lab conditions, Amin explained, adding that testing vials is also integral to the approval process for vaccines: After a vaccine is placed in a glass vial, the complete package including the rubber stopper is studied for the vaccine’s stability. Only after this do companies prepare a full dossier to send to national drug regulators for approval, he said. The actual number of vials needed will also depend on whether an approved COVID-19 vaccine will be administered as a single dose or multiple doses per vial, he said.
India makes vaccines for the world
Indian vaccine-makers supply the bulk--40%--of the global capacity of about 5.7 billion doses annually, according to a recent report by Bernstein Research, a global analytics firm. Home to some of the world’s biggest vaccine makers, India produces 2.3 billion doses of vaccines yearly, with 74% for export, said the report.
At present, 42 COVID-19 vaccine candidates under different stages of trial around the world are being monitored by the WHO. Indian vaccine-makers are either doing research and development for COVID-19 vaccines themselves, or have tied up to manufacture a vaccine when one is ready.
For instance, Pune-based Serum Institute of India is slated to mass produce the vaccine being jointly developed by the University of Oxford and the British-Swedish company AstraZeneca, when ready. “SII is the largest [Indian vaccine maker] by far with a capacity of ~1.5 bn [around 1.5 billion] doses. Biological E and Bharat Biotech follow with ~0.5 bn doses each,” said the report.
Focus on COVID-19 vaccine could eclipse child immunisation
Many experts on vaccination are worried that the COVID-19 vaccine effort could hijack the focus from immunisation of children and pregnant mothers. India’s UIP is already dealing with a birth cohort of 26 million children every year, and “it should not be stretched”, said Kang.
India doesn’t have a universal adult vaccination programme, for example for flu shots, the human papillomavirus (commonly known as HPV) or the pneumococcal vaccine. If the COVID-19 vaccination programme hopes to ride on the children’s programme, then it will be burdening an already creaking system.
Routine immunisation has already been stretched during the COVID-19 lockdown. Between January and August 2020, only 12 million children were vaccinated, a coverage of 68.5% in eight months, according to data from the Union health ministry. But 17.8 million children should have been vaccinated in these months to meet the UIP 2019 goal of vaccinating 26.7 million infants every year. This means 5.8 million fewer children could have been vaccinated during this period.
India’s routine vaccination programme has struggled to meet its goal of vaccinating 55.7 million people annually over the past five decades, according to the UIP five-year plan, 2018. From 44% coverage in 2005-06, 62% of children and mothers were fully immunised in 2015-16--a decadal growth of 18 percentage points, but still far short of target. Vaccination also dropped among vulnerable communities, depending on wealth status, caste or tribal status and level of education. For instance, just under half of India’s Scheduled Tribes’ children and mothers (44%) have not received full immunisation coverage, according to the UIP five-year plan. Less than 10%, or 54, of India’s 718 districts had immunisation coverage over 90%; 91 had less than 50% immunisation coverage, according to UIP 2019.
Routine immunisation could fall further if the focus shifts heavily to the COVID-19 vaccine in 2021. “India has celebrated great success at eradicating polio because of the intense, focussed vaccination programme,” Thomas Abraham, author of ‘Polio: The Odyssey of Eradication’, told IndiaSpend. “But the years spent with nearly single-minded focus on polio also meant that other routine vaccinations suffered.”
Rakesh Kumar, former joint secretary in the MoHFW who oversaw India’s vaccine programme in the 2000s, agreed: “India’s routine immunisation programme for children has been built up by decades of hard work. It should not suffer at any cost now.” He recalled the frenetic pace of the programme during 2001-11 when resources and attention were trained on polio, and warned that a similar situation should not recur with the COVID-19 vaccine.
The reasons for failing to meet national immunisation targets are varied, including failure to adequately inform parents about when and where immunisation is happening. There is also “vaccine hesitancy and public mistrust”, the MoHFW said in 2019, as well as “rumours, myths and misinformation” about vaccines. Many are unaware of the benefits or adverse effects of vaccines.