vaccinating a population of 940 million: The story so far, Many States have announced their intention to import COVID-19 vaccines through a global bidding process, and several tenders inviting Expression of Interest have been issued, including by Uttar Pradesh, Tamil Nadu, Odisha, Karnataka, Andhra Pradesh and Uttarakhand, and also by the Brihanmumbai Municipal Corporation for Mumbai.
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Is the onus on States to procure vaccines?
The Centre is currently pursuing a ‘Liberalised Pricing and Accelerated National Covid-19 Vaccination Strategy’, under which it has left vaccination of people in the 18-44 years age group to the States from May 1. State governments have to call for vaccine bids in an open market in the case of international imports and buy a limited domestic supply at prices fixed by the manufacturer.
Vaccine makers in the country are required to provide 50% of their production to the Centre to meet the needs of the 45-plus priority age group, besides 25% to the States, and leave the rest open for purchase by the private sector. The strategy was submitted in the Supreme Court by the Centre in the suo motu case as a step taken in an effort to incentivise and grow vaccine manufacturing. Earlier, the Drugs Controller General of India issued guidance on April 15 stipulating the conditions for the import of vaccines for restricted use in emergency situations.
What is the state of vaccine availability?
For the 18-plus age group, India has a population of about 940 million, and Census-based projections put the 18-44 age group at over 591 million. This makes up a total requirement of about 1.9 billion (or 190 crore) vaccine doses, at two doses each.
Union Health Minister Harsh Vardhan said on May 12 that India’s domestic vaccine production in May is likely to be 8 crore doses and about 9 crore doses in June. Considering that over 18 crore doses have been administered as of May 15, of which around 14 crore are only the first dose, there is a requirement of 172 crore doses more to cover the target population.
NITI Aayog member V.K. Paul has said that overall, 216 crore doses of vaccines could be available in India between August and December 2021. But this optimistic estimate includes 130 crore doses of Covishield (75 crore) and Covaxin (55 crore), and 15.6 crore doses of Sputnik V, while the rest — Bio E sub-unit, Zydus Cadila DNA, SII-Novavax, BB Nasal and Gennova mRNA — represent vaccine candidates in trials. In addition, Dr. Paul said Indian authorities were actively encouraging Moderna, Pfizer and Johnson & Johnson to apply for emergency use authorisation (EUA) for their vaccines. Pfizer had applied for EUA in India but withdrew it in February this year as the regulatory authority sought additional information on its vaccine.
For those not eligible for free immunisation and others who go to a private provider, prices range from ₹600 to ₹1,200 a dose for the two available vaccines, besides any hospital charges. Dr. Reddy’s Laboratories has announced a price of ₹995.40 per dose for the new entrant, the imported Sputnik V vaccine. The rule for private hospitals receiving vaccines from the government, which capped the price at ₹250 a dose, has been discontinued.
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vaccinating a population of 940 million:
Why do States need to import?
While the States will continue to get vaccines under the Central quota for those above 45 years, they must prepare for beneficiaries in the 18-44 years age group using their own resources; private hospitals will sell to the better-off sections, mainly in urban areas, using imports. States are allowed to order only an approved number of domestically manufactured doses for the 18-44 years group, on a pro-rata basis fixed by the Central government based on a population estimate. Imports, therefore, come into play to meet the demand early.
Pressure for vaccines continues to mount on governments amid the wildfire spread of the infection, with the country seeing around 400,000 cases and almost 4,000 deaths a day. This has led to several decisions that the Centre claims will improve availability. These include direct import of vaccines by States and private entities for immediate use, promoting wider domestic manufacture of Covaxin, and, if intellectual property restrictions are relaxed, domestic manufacture of foreign vaccines, which experts say will take time.
At the same time, there is a demand for a free, central vaccine procurement programme to cover every citizen. Leaders from 12 political parties, including four Chief Ministers, asked the Centre to procure vaccines, domestic and international, for universal immunisation. West Bengal Chief Minister Mamata Banerjee had recently appealed to the Prime Minister for speedy import of approved vaccines and help to set up franchised production units in India, for which her State would provide land and all support.
How do vaccine imports work?
In the Centre’s scheme, an “incentivised” market will increase the number of manufacturers, and thus, the availability of vaccines, although the counter view is that the decentralised, unregulated procurement system will push up costs due to weak bargaining power, and with global shortages, only pave the way for profiteering.
Imports have to meet the norms stipulated by the Centre. As per the Central Drugs Standard Control Organisation (CDSCO) guidance of April 15, which is based on the recommendations of the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC), foreign-produced vaccines granted emergency approval for restricted use by specified regulators such as the United States’s Food and Drug Administration (FDA), the European Medicines Agency (EMA) in Europe, United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA), Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, or which are listed in the World Health Organization’s (WHO) Emergency Use Listing, may be granted emergency approval in India. After approval, these vaccines must be subjected to a bridging clinical trial in place of a local clinical trial, as per the New Drugs and Clinical Trials Rules, 2019.
Also, the first 100 beneficiaries must be assessed for safety outcomes for seven days, before a vaccine is rolled out as part of the vaccination programme. To speed up the availability of more vaccines, the CDSCO will process applications for restricted use in three days and registration and import formalities will be completed in three days thereafter. Every batch of a vaccine would have to be tested and released at the Central Drugs Laboratory (CDL), Kasauli, says the order.
Have States issued tenders under the new plan?
A number of States have constituted committees to finalise import modalities and many official tenders have been published. Uttarakhand said it would import 2 million doses of Sputnik V over two months.
The Uttar Pradesh tender for 40 million doses, which closes on May 21, specifies that the “goods supplied must be as per the guidelines of the ICMR”. The State seeks six to eight million doses every month, starting seven days from the issue of the purchase order, and requires the bidder to have an import licence and import registration certificate as well as the necessary transport cold chain infrastructure. U.P. Medical Supplies Corporation, the importer, has specified a vaccine storage temperature of 2°C to 8°C in nine warehouses.
Tamil Nadu has issued a tender for 50 million doses of vaccines to be delivered progressively in 90 days from the date of order, with the bid closing on June 5. Odisha has invited bids for 38 million doses, with online bids closing on May 28. Karnataka has announced that it will procure 20 million doses, while Andhra Pradesh has identified 20.4 million people for coverage in the 18-44 years group.
The Brihanmumbai Municipal Corporation (BMC) in Mumbai has floated a tender for 10 million doses from COVID-19 vaccine manufacturers, their Indian partners, wholesalers of manufacturers or authorised distributors of manufacturers, but barred applicants from “countries sharing borders with India”. This condition, in effect, rules out China’s two-dose Sinopharm vaccine that was approved by the WHO earlier this month. Moreover, the responsibility to maintain the cold chain and supply the vaccine at the main storage facility, any hospital or vaccination centre, is that of the applicant. In addition, taking into account the very low storage temperatures required for some vaccines such as Pfizer (-80°C and -60°C up to expiration date but refrigerated at 2°C to 8°C up to 120 hours), the tender says the responsibility to maintain such infrastructure up to the vaccination point would be that of the bidder. The Mumbai civic body currently has 20 hospitals and 240 vaccination centres.
Given the complexities, States feel it is the Centre that should negotiate prices, set terms and get vaccines delivered to them from international and domestic companies, to meet the challenge of universal coverage and get the country back on its feet.(vaccinating a population of 940 million)