Responsive COVID-19 Vaccines for Recovery Project under the Asia Pacific Vaccine Access Facility (IND RRP 55082-001)

NATIONAL DEPLOYMENT AND VACCINE ALLOCATION PLAN

I. BACKGROUND

1. The World Health Organization (WHO) declared the coronavirus disease (COVID-19) infection a pandemic on 11 March 2020.1 The first case of COVID-19 in India was reported on 30 January 2020. However, a rise in number of cases was observed from March 2020 onward. The country has had two “waves” of the pandemic. It is currently recovering from a devastating second wave which peaked with a record high of 414,188 new COVID-19 cases on 7 May 20212. Cumulatively 34.37 million confirmed cases3 and 461,3894 deaths were reported as of 10 November 2021. The Government of India, recognizes vaccination as a crucial public health intervention in response to the pandemic, especially to minimize mortality and initiated the COVID-19 national vaccination program on 16 January 2021. Three vaccines—Covishield (manufactured by Serum Institute of India [SII]), Covaxin (manufactured by Bharat Biotech),5 and Sputnik V (developed by Gamaleya Research Institute)6—are currently deployed as part of the COVID-19 national vaccination program. In addition, three additional vaccines—Moderna, Janssen, and ZyCoV-D—have received emergency use authorization by the Drug Controller General. India aims to vaccinate 944.7 million eligible beneficiaries (68.9% of population) by December 2021. Domestic manufacturing capacities, the COVID-19 Vaccines Global Access (COVAX) facility, and bilateral vaccine deals are the key sources of vaccine supply in India. As of 9 November 2021, more than 1.09 billion vaccine doses have been administered in more than 11.07 million sessions.7 2. The government has established governance mechanisms across all levels for efficient planning and coordination of the COVID-19 national vaccination program, which are clearly delineated within the National Deployment and Vaccination Plan (NDVP) for COVID-19 Vaccines. At the central level this mechanism includes the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC). Guided by the principles detailed within the NDVP and informed by the recommendations of the World Health Organization (WHO) Strategic Advisory Group of Experts on Immunization (SAGE), NEGVAC is responsible for advising the government on all aspects of COVID-19 vaccine program.8 This includes (i) providing regulatory guidance on vaccine trials; (ii) prioritization of population groups and ensuring equitable vaccine distribution; (iii) advising on vaccine selection, procurement arrangements, vaccine financing, and delivery mechanisms; (iv) vaccine safety surveillance; and (v) assisting neighboring countries.9 NEGVAC is further supported by the National Technical Advisory Group on Immunization (NTAGI). A COVID-19 working group is constituted within NTAGI to provide recommendations on selection of COVID-19 vaccines, advising on issues related to contraindications, and other technical issues related to COVID-19 vaccination. The NDVP also outlines the country's comprehensive biomedical waste management (BMWM) arrangements while implementing the vaccination program. The Governor's Letter (Appendix 1) confirms the government's commitment to implement its COVID-

1 World Health Organization (WHO). Virtual Press Conference on COVID-19 – 11 March 2020. Geneva. 2 Press Information Bureau. Ministry of Health and Family Welfare (MOHFW) official release. Delhi. 3 Government of India. MOHFW. Delhi. 4 Government of India. MOHFW. Delhi. 5 Press Information Bureau. MOHFW official release. Delhi. 6 Press Information Bureau. MOHFW official release. Delhi. 7 Press Information Bureau. MOHFW official release. Delhi. 8 NEGVAC is chaired by the member (health) of NITI Aayog and co- chaired by the secretary of MOHFW with

representatives from various ministries, departments and five state governments. NEGVAC serves as both the technical working group and the coordination committee for national vaccine program.

9 Press Information Bureau. MOHFW official release. Delhi.

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19 vaccine allocation plan, and its compliance with policies and regulations on BMWM as detailed in NDVP (Appendix 3). 3. Prioritization of target groups for COVID-19 vaccination in India is informed by the recommendations of SAGE,10 emerging epidemiological evidence, and global best practices.11 The recommendations are provided by two key technical bodies including NTAGI and NEGVAC, for incorporation in the COVID-19 national vaccination program implemented by the Ministry of Health and Family Welfare (MOHFW). The government, in its course of implementing the COVID-19 national vaccination program, has followed a dynamic mapping model based on availability of vaccines and coverage of vulnerable priority groups in deciding vaccination among various age-groups.12 The government allocates vaccines to states and union territories based on (i) pro-rata target population, (ii) progress of vaccination in the area, and (iii) vaccine wastage.13 Around 40% of the available vaccines is given to states and union territories on a pro-rata basis of target population, with higher allocation to areas with larger populations. Meanwhile, 5% of the available vaccines is provided to states and union territories based on active case load, with higher allocation to areas with greater number of active cases. Finally, 5% of the available vaccines is given to states and union territories with wastage rates less than national average. Such allocation is on pro-rata basis of consumption. 4. India has thus far implemented four phases of the COVID-19 national vaccination program for the identified priority population groups. In line with the recommendations of NDVP, health care workers constituted the first target group at the launch of the program on 16 January 2021. This was followed by extension of the vaccination to frontline workers on 2 February 2021. From 1 March 2021, vaccinations were opened to those aged 60 years and above, and those aged 45–60 years with selected comorbidities.14 From March 2021 onward, an upward tick in the reported number of COVID-19 cases prompted the government to expand the vaccine eligibility to additional population groups. Consequently, all citizens above 45 years of age were included as eligible beneficiaries from 1 April 2021;15 further, all above 18 years were included in the vaccination program from 1 May 2021. In addition, upon the recommendation of NTAGI and NEGVAC, the government on 2 July 2021 further approved vaccination of pregnant women against COVID-19.16 India currently aims to vaccinate 68.9% of its population by December 2021. Table 1 details the vaccine prioritization plan for India.

10 WHO. 2020. WHO SAGE Roadmap for Prioritizing the Uses of COVID-19 Vaccines in the Context of Limited Supply.

Geneva. 11 Press Information Bureau. 2021. COVID19 Vaccination: Myth vs. Facts. News release. 1 July. 12 Press Information Bureau. 2021. Government of India announces a Liberalised and Accelerated Phase 3 Strategy

of Covid-19 Vaccination from 1st May. News release. 19 April. 13 Government of India, Ministry of Health and Family Welfare. Lok Sabha Unstarred Question No. 912: Procurement

of COVID Vaccines. New Delhi. 14 Press Information Bureau. 2021. Registration for Next Phase of Vaccination. News release. 28 February. 15 Press Information Bureau. 2021. Update on COVID-19 Vaccination. News release. 1 April. 16 Government of India, MOHFW. 2021. Pregnant Women now eligible for COVID-19 Vaccination. News release. 2

July.

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Table 1: India – Priority Population Groups for Various Phases of Vaccination Against the Coronavirus Disease

Phases Timing Priority Group Estimated

Populationa % of Total

Population b

No. of Doses

Required (M)c

1a 16 Jan 2021 Healthcare workers 10,000,000 0.73 21.05

1b 2 Feb 2021 Frontline workers 20,000,000 1.46 42.10

2a 1 Mar 2021

Senior citizens (≥ 60years) and those aged 45–59 years with defined comorbidities 138,060,681 10.07 290.7

2b 1 Apr 2021d

Population 45–59 years of age 209,316,946 15.27 440.7

3 1 May 2021

Population 18–44 years of age 597,331,969 43.57 1,257.5

Total 944.709596 68.91 1,988.9 a Remaining population (population below 18 years of age) is not being considered for the vaccination at present. b Total Population = 1,370.88 million. c Assuming a two-dose regime and 5% wastage based on past vaccination trends. d Population aged 45–59 years with co-morbidities were made eligible for vaccine access on 1 March 2021 along

with the priority group of senior citizens (60 years and above) followed by extension of vaccine access to all citizens aged 45 years and above from 1 April 2021.

Source: Ministry of Health and Family Welfare.

5. COVID-19 vaccine service delivery is available in private hospitals as well. The NDVP and MOHFW COVID-19 Vaccines Operational Guidelines, 202017 delineate the broad contours of private sector participation. Initially, the government permitted the empaneled private health facilities within various national and state health insurance schemes to function as COVID-19 vaccination centers (CVCs). This included 10,000 hospitals under Ayushman Bharat - Pradhan Mantri Jan Arogya Yojana and 687 hospitals under the Central Government Health Scheme.18 However, from Phase 2 (which began in March 2021), all private sector hospitals were allowed to act as private CVCs.19,20 To ensure that access to vaccination continues to remain affordable, the private sector is permitted to charge up to a maximum of 150 rupees (₹) ($2.1) per dose as service charges. Apart from hospitals, MOHFW has allowed for COVID-19 vaccination sessions at private sector workplaces. The overall service delivery through the private sector, has however, stayed low at 7% of total vaccinations.21 6. India has a robust digital mechanism for registration of vaccine beneficiaries through the Winning Over COVID-19 (Co-WIN) online technology platform. The platform, which is an extension of the existing electronic Vaccine Intelligence Network (eVIN)22, acts as an end-to-end solution for managing the vaccination program. At the program level, Co-WIN provides real time information on total registrations and vaccinations (split by age, gender, first or second doses,

17 Government of India, Ministry of Health and Family Welfare. 2020. COVID-19 Vaccines Operational Guidelines. New

Delhi. 18 Press Information Bureau. 2021. Update on COVID19 Vaccination. News release. 2 March. 19 Press Information Bureau. 2021. COVID19 Vaccination: Myth vs. Facts. News release. 1 July. 20 Press Information Bureau. 2021. Centre issues Guidance Note to Operationalize COVID Vaccination Centres at

Work Places (Govt. and Private). News release. 7 April. 21 Government of India. 2021. Rajya Sabha Unstarred Question No.252. Delhi. 22 eVIN is an innovative technological solution developed and implemented by United Nations Development

Programme (UNDP) in partnership with MOHFW and supported by the Global Alliance for Vaccines, the vaccine alliance to support India’s Universal Immunization Programme (UIP). eVIN was introduced by MOHFW in 2015 across 12 states to strengthen immunization supply chain systems across the country by providing real-time information on vaccine stocks and flows, and storage temperatures across all cold chain points in the country.

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vaccines used, and urban or rural); along with providing state-specific information, and overall vaccination trends. At the beneficiary level, Co-WIN allows for booking of vaccine slots (by type of vaccine and type of provider) and further facilitates generation of vaccine certificates for those completing the two doses.23 The Co-WIN is supplemented by the e-VIN for COVID-19 vaccine delivery and logistics in the country. 7. Approximately 11% of the total COVID-19 cases in the country have been reported in persons aged less than 20 years in the country.24 Currently, the three-dose ZyCoV-D vaccine has been provided emergency use approval by the Drug Controller General of India for administration in the 12 years and above age group. On 12 May 2021, the Drug Controller General of India had permitted Bharat Biotech to conduct Phase II and Phase III clinical trials of Covaxin in 525 healthy volunteers in the age group of 2–18 years.25 SII has also received recommendation from the Subject Expert Committee of Central Drugs Standard Control Organization to conduct Phase II and Phase III trials of Covovax on 920 children aged 2–17 years across 10 sites.26 In addition, Janssen has sought permission to conduct trials in the 12–17 years age group. Any recommendation on initiating COVID-19 vaccination in additional age groups, along with issues such as provision of booster doses and interchangeability of vaccine doses, will be based on SAGE recommendations and scientific evidence (including from in-country research studies). 8. ADB considers the proposed prioritization of vaccine access indicated in the NDVP consistent with international norms and safeguards against the exclusion of marginalized and vulnerable groups.

II. MEDICAL WASTE MANAGEMENT PLAN

9. The Central Pollution Control Board (CPCB), under the Ministry of Environment, Forest and Climate Change is the technical agency responsible for enforcing the regulatory provisions and providing technical guidance on BMWM in the country. It is assisted through a network of state pollution control boards and pollution control committees. The government has a robust regulatory framework to ensure safe and efficient management of biomedical waste (BMW). The Biomedical Waste Management Rules, 2016 issued by CPCB (henceforth BMWM Rules, 2016) and its subsequent amendments comprise key regulations that require registration of health facilities and details the necessary compliance requirements related to BMW generation, storage, transportation, disinfection, along with treatment and disposal. In addition, the BMWM Rules, 2016 also outlines the provisions for obtaining authorization for BMWM, and provides monitoring and reporting requirements for health care facilities (HCFs) involved in BMW generation and management. As per these guidelines, the responsibility of waste segregation lies with the health care facility (HCF), while waste collection, transportation, and treatment lie with the common biomedical waste treatment facility (CBWTF) operator (in cases where the captive disposal facility is not available with the health facility). Other roles and responsibilities of both have also been specified. All BMW-related aspects of COVID-19 national vaccination program are required to comply with this regulation. In addition to the BMWM Rules 2016, other important regulations in relation to the BMWM activities are provided in Appendix 2.

23 Press Information Bureau. 2021. COVID-19 Vaccination Update- Day 222. News release. 25 August. 24 Government of India. Lok Sabha Unstarred Question No. 855: Corona Vaccines for Children. Delhi. 25 Press Information Bureau. 2021. DCGI approves Phase II/III clinical trial of COVAXIN in the age group of 2 to 18

Years. Press release. 13 May. 26 The Indian Express. 2021. Govt Panel Recommends Nod to SII for Phase 2/3 Trials of Covovax on Children Aged

2-17. News Release. 27 July.

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10. In addition to seeking compliance on various BMW-related regulations, MOHFW and CPCB have coordinated closely to ensure that consistent guidelines are made available to implementers, health facilities, and other stakeholders on the management of BMW generated during the COVID-19 national vaccination program. These guidelines aim to address emerging issues related to management of incremental generated due to the COVID-19 pandemic and the national vaccination program. Key guidelines in this regard include the following:

(i) Guidelines for Handling, Treatment, and Disposal of Waste Generated during Treatment, Diagnosis, and Quarantine of COVID-19 Patients, 2020 (revised in 2021). These guidelines are required to be followed by all facilities engaged in COVID-19 management including isolation wards, quarantine centers, sample collection centers, laboratories, urban local bodies, and CBWTFs. It also provides recommendations on disposal of personal protective equipment, which are to be followed for the COVID-19 national vaccination program, as well.

(ii) Guidelines on Management of Bio-medical Waste under Universal Immunization Programme (initially released in 2004, revised in 2016, 2017, 2018, 2021). These guidelines provide step-by-step directions for management of BMW generated from the Universal Immunization Programme, including provisions for training of health care workers, segregation, labelling, record-keeping, transportation, packaging, treatment, and disposal of biomedical and solid waste generated from vaccination programs. It is applicable for waste generated from the COVID-19 national vaccination program and is to be complied with in conjunction with BMW Rules 2016.

(iii) MOHFW COVID-19 Vaccines Operational Guidelines, 2020. These guidelines provide guidance for management of BMW generated specifically during the COVID-19 national vaccination program. It recommends for ensuring training of waste handlers specifically on risks associated with COVID-19 related BMWM; proposes mechanisms for transportation logistics and methods of waste treatment; and expounds on the role of BMW disposal facilities. In addition, the guideline outlines the role of vaccination officers in management of BMW generated during the COVID-19 national vaccination program. Specifically, state and district authorities (district immunization officer, chief medical officer or the block medical officer) are required to ensure the availability of hub cutters, red and yellow bags, blue puncture proof containers and bags for municipal waste, and other essential BMWM supplies prior to initiation of vaccination program.

11. The NDVP also details key steps to ensure vaccine safety and responsible BMWM. It specifically recommends the following measures to be followed during the vaccination program: (i) hub of the auto-disposable syringe should be cut immediately after administering the injection using the hub cutter; (ii) puncture proof containers should be used for collecting cut needles and the plastic portion segregated and stored in red bags; (iii) plastic wrapper and cap of the syringe should be treated as municipal general waste; (iv) hub cutters should be treated with sodium hypochlorite before reuse; (v) broken vials to be stored in puncture-proof blue containers; and (vi) waste generated during the outreach session to be handed to the nearest primary health centers for further disposal. 12. Regarding the reverse logistics of vaccines, it is recommended that all vials (including empty, unused, and partially used vials) should be returned through alternate vaccine delivery to the vaccine distribution and/or ice-lined refrigerator point, maintaining a reverse cold chain. It is

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further clarified that (i) returned unopened vials be properly marked and stored immediately at the correct temperature; (ii) marked vials should be supplied and used first; and (iii) all used or empty COVID-19 vaccine vials, at the end of the session, should be kept in a separate zip lock bag and returned to the ice-lined refrigerator point. The Co-WIN provides information on stock and consumption patterns to ensure that all vaccine vials are fully accounted for in all vaccine stores. All public and private vaccination centers are required to maintain a daily vaccine utilization report, under which every vaccinator reports on metrices such as vials received, vials opened, and vials used completely or partially. Figure 1 illustrates the BMW plan proposed for the COVID-19 national vaccination program.

Figure 1: Immunization Waste Segregation, Transportation, Treatment and Disposal under the COVID-19 National Vaccination Program

BMWM = biomedical waste management, CBWTF = common biomedical waste treatment facility, CPCB = Central Pollution Control Board. Sources: Government of India, Ministry of Environment, Forest, and Climate Change. 2016. Bio-Medical Waste Management Rules. New Delhi: Central Pollution Control Board; and Government of India, Ministry of Health and Family Welfare. 2020. COVID-19 Vaccines Operational Guidelines. New Delhi.

13. ADB has further undertaken an assessment on COVID-19 immunization waste management plan as part of its due diligence. The assessment has indicated that the amount of BMW expected to be generated from the COVID-19 national vaccination program is nominal (approximately 4.21% increase in capacity utilization requirements of CBWTFs) in comparison to the overall BMW generated within the country. Further, the total BMWM capacity is 1,200 tons/day (of which incineration capacity is 814 tons/day); and the BMWM in APVAX program states27 is

27 These include Uttar Pradesh, Maharashtra, Bihar, West Bengal, Tamil Nadu, Andhra Pradesh, Madhya Pradesh,

Rajasthan, Karnataka, Gujarat, Odisha, Kerala, Jharkhand, Assam, Punjab, Telangana, Haryana, Chhattisgarh, and Delhi.

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1,158.8 tons/day. The average amount of COVID-19-related BMW is reported as 203 tons/day for the country and derived to be about 191.5 tons/day in APVAX program states per CPCB Report January–May 202128. It is estimated that cumulative BMW generation (COVID-19 + non-COVID-19 BMW) will be 816 tons/day for India and 773 tons/day for APVAX states. Against the total existing capacity for BMWM of 1,200 tons/day across the country and 1,158.8 tons/day in APVAX states, the utilization capacities are approximately 68% and 66.6% in country and APVAX states, respectively. While there are interstate variations in the utilization capacity of CBWTFs, it is estimated that all 19 APVAX program states will be adequately able to manage the additional BMW through existing facilities or through ongoing infrastructure enhancement. The current infrastructure for BMWM includes 202 CBWTFs; 18,015 captive treatment facilities (installed at HCFs); 136 captive incinerators (operated by HCFs); 15,745 deep burial pits at HCFs, and 33 deep burial pits at CBWTFs. BMW infrastructure in APVAX project states include 190 operational CBWTFs; 8,337 captive treatment facilities (installed at HCFs); 84 captive incinerators (operated by HCFs); 7,290 deep burial pits at HCFs; and 31 deep burial pits at common biomedical waste treatment facilities. 14. To better track, monitor, and manage the incremental BMW due to COVID-19 treatment and vaccination program, a COVID-19 BMW tracking app named “COVID19BWM” available as a mobile app as well as a web portal, for use by waste generators, transporters, CBWTF operators, state pollution control boards, pollution control committees, and urban local bodies.29 In May 2021, 186 out of 198 CBWTFs reported COVID-19 BMW generation on the app. Further, trainings on the processes to be followed at the vaccination sites, including those related to BMWM, have been conducted for various categories of staff such as vaccination officers, supervisors, cold chain handlers, data entry operators, medical officers, and program managers. Some 2,360 participants have been trained during the national level training of trainers. As of 31 December 2020, more than 57,000 participants have been trained in district level trainings across 719 districts.30 WHO is also supporting the government in conducting trainings for COVID-19 vaccine introduction and safe BMWM; and has reported conducting cascaded trainings for nearly 260,000 vaccinators and 475,000 vaccination team members officers across the country.31

III. VACCINE PROCUREMENT PLAN

15. The government aims to vaccinate 944.7 million beneficiaries by December 2021 (68.9% of the total population). Under the COVAX facility advanced market commitment (AMC) arrangement, allocation approved for India by the Global Alliance for Vaccines and Immunization board is 20.0% of total AMC doses. Initially, as COVAX's target was to secure 1.3 billion doses for 92 AMC countries, 260 million doses (20.0%) were allocated for India. COVAX has now however, secured 1.8 billion doses; therefore, India’s country allocation is now increased to 360 million doses (20.0%). The government, however, does not plan to avail of additional doses from COVAX in 2021 (apart from the 10 million doses already received). This is in consideration of the export ban placed and needs of other developing countries. In addition to donation from COVAX,

28 Government of India, Ministry of Environment, Forest and Climate Change. 2021. Generation of COVID-19 Related

Biomedical Waste in States/UTs. January–May. New Delhi: Central Pollution Control Board. 29 National Green Tribunal. 2020. Consolidated Status Report in the matter of O.A. NO. 72 of 2020 In re: Scientific

Disposal of Bio-Medical Waste Arising out of Covid-19 Treatment – Compliance of BMWM Rules, 2016 before Hon’ble National Green Tribunal, Principle Bench. Delhi.

30 Press Information Bureau. 2020. Centre asks States/UTs to gear up for roll out of COVID19 Vaccine. Press release. 31 December.

31 World Health Organization. 2021. India Shares Vaccination and Clinical Research Know-how for Countries to Customize and Adapt. Geneva.

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the Prime Minister's Citizen Assistance and Relief in Emergency Situations Fund has also funded 66 million doses in the phase 1 of the COVID-19 national vaccination program. 16. While implementing the COVID-19 national vaccination program for more than half a year, several scenarios have evolved beyond the anticipations within the NDVP. A key change has been the less than anticipated wastage in vaccine doses and extraction of additional doses per vial as against those declared by the manufacturer. Thus, while NDVP assumed a wastage of 10% vaccine doses, implementation experience has shown that India is reporting significantly less vaccine wastage (with several states reporting zero wastage at different points of time during the national vaccination program). For instance, between 1 May 2021 to 13 July 2021, only eight states and union territories reported vaccine wastage (including, among others, Bihar, Delhi, Manipur, Meghalaya, Puducherry, Tripura, and Uttar Pradesh). Meanwhile, 411,516 additional doses were extracted from allotted supplies across states.32 Assuming a two-dose regimen and 5% wastage—as observed in the COVID-19 national vaccination program thus far—India is estimated to require 1,988.9 million doses to vaccinate its 944.7 eligible population. The total vaccine financing requirement is estimated to be $7,532.28 million. This includes vaccine cost of $6,272.06 million as vaccine cost and $1,260.22 as operational costs (Table 2).

Table 2: Sources of Vaccine Procurement and Estimated Financing Need for India’s COVID-19 National Vaccine Program

Financing Sources Eligible Population Coverage (million)

Doses Requireda (million doses)

Vaccine Costb ($ million)

APVAX ADB 237.50 500.00 1,500.00

AIIB 79.50 167.00 500.00

GOI GOI 559.67 1,178.60 4,542.51c

Others Private Sector 31.96 67.29 756.65 COVAXd 4.75 10.00 30.00

PM-CARESd 31.35 66.00 203.12

Total 944.73 1,988.89 7,532.28 ADB = Asian Development Bank, AIIB = Asian Infrastructure Investment Bank, APVAX= Asia Pacific Vaccine Access Facility, COVAX= COVID-19 Vaccine Global Access, COVID-19 = coronavirus disease, PM-CARES= Prime Minister's Citizen Assistance and Relief in Emergency Situations. Note: The national COVID-19 vaccination program is financed through the government’s own resources, development

partners and other donors. Total program cost was estimated assuming 5% vaccine wastage. Total vaccine costs are estimated at $6.27 billion and total operational costs of $1.26 billion.

a Assuming 5% wastage. b Includes operational costs. c Including central (remaining outside of APVAX) and state governments contributions, including vaccines, ancillary

supplies, and operational costs. d Donation. Source: Asian Development Bank estimates. . 17. The government has provided two COVID-19 Emergency Response & Health System Preparedness Packages, with the Phase 1 of package amounting to $2.05 billion (₹15,000 crores) and the phase 2 package amounting to $3.16 billion (₹23.123 crore). Further, approximately $4.79 billion (₹35,000 crore) is budgeted for implementation of COVID-19 Vaccination Programme in the fiscal year (FY) 2021–2022. As of July 2021, approximately $1.10 billion (₹8071.09 crore) has been reported to be spent on purchase of COVID-19 vaccines;33 and the country has already

32 Government of India. Lok Sabha Starred Question No.68: COVID-19 Vaccination. Delhi.

33 Government of India. Lok Sabha Unstarred Question No. 786. Delhi.

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deployed approximately 738.2 million doses.34 To support the government in meeting the costs of doses already deployed, the APVAX support will provide 30% in retroactive financing. 18. Financing needs and ADB support. The APVAX facility will finance the eligible expenditure for procurement of vaccines for a period of 3 years from 2021 to 2024 to ensure COVID-19 vaccine access for the country. Under the Responsive COVID-19 Vaccines for Recovery Project of APVAX, ADB will provide financing for eligible expenditure, presently for vaccine procurement only. The APVAX project will cover vaccine financing needs for 26.34% of the total population and 38.24% of the eligible population within the 19 project states. The financial envelope for support is of $2,000 million (including $500 million co-financing from Asian Infrastructure Investment Bank). The summary cost estimates is provided in Table 3 and the financing plan in Table 4.

Table 3: Summary Cost Estimates

Item Description Amount ($ million)

Share of Total (%)

A. Base Costa

Safe and effective COVID-19 vaccines suppliedb 1,930.15 93.80

B. Contingenciesc 69.85 3.39

C. Financial charges during Implementationd 57.77 2.81

Total (A+B+C) 2,057.77 100.00

COVID-19 = coronavirus disease. a In September 2021 prices, at an exchange rate of $1 = ₹73.00. b Including 5% tax on vaccines procured. c Includes physical and price contingencies, and a provision for exchange rate fluctuation. d Includes interest, commitment charges, and front fee. Source: Asian Development Bank estimates.

Table 4: Summary Program Financing Plan Project National Vaccination Programa

Source Amount

Share of Total

Amount Share of

Total

($ million) (%) ($ million) (%)

Asian Development Bank Ordinary capital resources 1,500.00 72.89 1,500.00 19.91

Asian Infrastructure Investment Bank 500.00 24.30 500.00 6.64

Government of India 57.77 b 2.81 4,542.51c 60.31

Other sources d - - 989.77 13.14

Total 2,057.77 100.00 7,532.28 100.00 a The national coronavirus-related vaccination program is financed through the government’s own resources,

development partners, and other donors. The total program cost was estimated assuming a 5% vaccine wastage. Total vaccine costs are estimated at $6.27 billion and total operational costs at $1.26 billion.

b The government will finance the interest, commitment charges, and front fee. c Includes central and state government contributions, vaccines, ancillary supplies, and operational costs. d Contributions from the private sector and donations. Source: Asian Development Bank estimates.

34 Press Information Bureau. MOHFW official release. Delhi.

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19. ADB is also supporting the Government of India with a $4 million technical assistance (TA)

to support the COVID-19 national vaccination program in several areas.35 The TA will strengthen

BMWM through capacity building of health care and frontline workers and various civil society

organizations. It will also support development of demonstration sites implementing best practices

in BMWM in select states. The TA will help in strengthening monitoring mechanisms and enhance

evidence-based policy inputs for improved preparedness in future pandemics. Further, the TA

would support the capacity building of providers within the private sector and support improved

quality of care and adherence to the vaccine guidelines in the private sector. To address the

needs of vulnerable and rural population groups, the TA will support enhanced risk

communication, community engagement and outreach activities, and engage newer structures

such as rural banks, and frontline staff beyond health sector to broaden the reach of vaccine

services to poor, women, older people, persons with disabilities and other disadvantaged groups.

20. Currently, the vaccines deployed for COVID-19 national vaccination program are

Covishield, Covaxin, and Sputnik V. However, in April 2021, the government fast-tracked the

regulatory system for COVID-19 vaccines approved for restricted use by the United States Food

and Drug Administration, European Medicines Agency, United Kingdom’s Medicines and

Healthcare Products Regulatory Agency, Japan’s Pharmaceuticals and Medical Devices Agency

(PMDA), and those that are listed in the WHO Emergency Use Listing. This was done to

encourage imports of bulk drug material and optimal utilization of domestic fill and finish capacity

(which in turn is expected to provide a fillip to vaccine manufacturing capacity). The government

continues to seek access to additional vaccines that can be supplied within a reasonable

timeframe and can be deployed through infrastructure available in the public or the private sector.

In addition to three vaccines that are already deployed, India has provided emergency use

approval to Moderna, Janssen and ZyCoV-D vaccines as well. Table 5 summarizes the COVID-

19 vaccines that are currently being considered by the government and their respective regulatory

status:

Table 5: COVID-19 Vaccine Candidates Considered by the Government

Vaccine Indian Manufacturers Indian NRA status COVAX APVAX

Covishield Serum Institute of India (licensure)

Approved for emergency use

Eligible Eligible (C1, C2)

Covaxin Bharat Biotech (licensure), Haffkine BioPharma, BIBCOL and IIL (contracts)

Approved for emergency use in clinical trial mode Phase II and Phase III clinical trials in the age group of 2–18 year ongoing

Eligible under WHO EUL

ZyCoV-D Zydus Cadila (licensure) Three dose schedules approved for emergency use in 12 years and above age group

Sputnik-V Dr. Reddy’s, Panacea Biotech, Virchow Biotech, Stelis Biopharma, Gland Pharma, Hetero Biopharma, and Serum Institute of India (contracts)

Approved for emergency use (Phase II trial ongoing)

35 ADB. 2021. Technical Assistance to India for Supporting COVID-19 Response and Vaccination Program. Manila.

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Vaccine Indian Manufacturers Indian NRA status COVAX APVAX

Janssen Biological E (contract) Approved for emergency use Application filed with regulator for conducting trial in 12–17years age group

Eligible Eligible (C1)

Moderna NA (to be imported by Cipla) Approved for emergency use

Eligible Eligible (C1, C2)

Corbevax Biological E (licensure) Phase III trial ongoing Approval granted for Phase II and Phase III study in children and adolescents

Covovax Serum institute of India (licensure)

Phase II and Phase III trials ongoing Phase II and Phase III trials for those aged 2–17 years recommended by regulator

Eligible (C1)

BBV154 Bharat Biotech Phase I trial ongoing

HGCO19 Gennova Biopharma (licensure) Phase I and Phase II trials ongoing

UB-612 Aurobindo Pharma and Vaxxinity Not yet approved for trial

APVAX = Asia Pacific Vaccine Access Facility, BIBCOL = Bharat Immunologicals and Biologicals Corporation Limited, COVAX = COVID-19 Vaccines Global Access, EUL = Emergency Use Listing, IIL = Indian Immunologicals Ltd., NRA = National Regulatory Authority, WHO = World Health Organization. Note: C1 and C2 refer to the APVAX eligibility criteria 1 and criteria 2 Source: Discussions with MOHFW, Updates made available by Indian Council of Medical Research and Vaccine manufacturing firms

21. The Government of India has requested ADB to support the COVID-19 vaccination

national program and the NDVP (Appendix 3). This includes support for forthcoming vaccine

procurement along with retroactive financing of doses procured thus far, and provision of a $4

million TA (footnote 35).

12 Appendix 1

GOVERNOR’S LETTER

Appendix 2 13

IMPORTANT REGULATIONS FOR ENVIRONMENTAL AND BIOMEDICAL WASTE MANAGEMENT

Regulation Key Feature

1. Environment (Protection) Act, 1986 subsequent amendmentsa

This is an ‘umbrella’ legislation providing general guidelines for prevention of environmental pollution.

2. Solid Waste Management (SWM) Rules, 2016b

These guidelines are applicable for disposal of plastic coverings used for syringes; empty paper/cardboard boxes and other packaging material used during the vaccination program.

3. Water (Prevention and Control of Pollution) Act, 1974 and subsequent amendmentsc

These guidelines are applicable for segregation of liquid chemical waste at source and ensuring pre-treatment or neutralization prior to mixing with other effluents generated from health care facilities during the vaccination program.

4. The Air (Prevention and Control of Pollution) Act. 1981 and subsequent amendmentsd

Provisions related to monitoring of gaseous emissions, emission of dioxins/ furans from incinerators and emission from diesel generator sets apply to the coronavirus disease (COVID-19) national vaccination program.

5. Hazardous and Other Wastes (Management and Transboundary Movement) Rules, 2016e

These guidelines are applicable for disposal of incineration ash; and for disposal of ash or vitrified material generated during treatment of waste generated from the vaccination program at health centers with inhouse /captive waste management facilities.

6. Plastic Waste Management Rules, 2016 and amendmentf

Plastic waste generated during the COVID-19 national vaccination program is required to be segregated at source and handed over to authorized recyclers as per the provisions under this regulation.

7. Guidelines for Bar Code System for effective management of bio-medical wasteg

These guidelines provide the technical specifications of a bar code system and guidance to implement the system.

8. Guidelines for Handling of Biomedical Waste for Utilizationh

These guidelines provide guidance to health care facilities as well as to industry/vendors for the purpose of management of biomedical waste to ensure handling of biomedical waste with adequate safeguards to protect community health and the environment

a Government of India. Ministry of Environment and Forests (Department of Environment, Forest and Wildlife). 1986. The Environment (Protection) Rules. New Delhi.

b The Gazette of India. 2016. Ministry of Environment, Forest, and Climate Change Notification. New Delhi. c Government of India. 1974. The Water (Prevention and Control of Pollution) Act. Delhi. d Government of India. 1981. The Air (Prevention and Control of Pollution) Act. Delhi. e The Gazette of India. 2016. Ministry of Environment, Forest, and Climate Change Notification. New Delhi. f The Gazette of India. 2016. Ministry of Environment, Forest, and Climate Change Notification. New Delhi. g Central Pollution Control Board. 2018. Guidelines for Bar Code System for Effective Management of Bio-medical

Waste. New Delhi. h Central Pollution Control Board. 2019. Guidelines for Handling of Biomedical Waste for Utilization. New Delhi.

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