India's COVID-19 Vaccine Rollout: Development, Approval and Implementation of the World's Largest Vaccination Program - RUDRA SAIGAL - Policy Brief
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Policy Brief Rudra Saigal
India’s COVID-19 Vaccine Rollout:
Development, Approval and
Implementation of the World’s
Largest Vaccination Program
RUDRA SAIGAL
2021
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Policy Brief Rudra Saigal
India’s COVID-19 Vaccine Rollout: Development,
Approval and Implementation of the World’s Largest
Vaccination Program
ABSTRACT: On January 16th 2021, the Government of India (GOI) began the largest inoculation
program in history. With the goal to vaccinate 1.5 billion people living in India, the GOI had chosen two
vaccines, Covaxin (manufactured by Bharat Biotech) and Covisheild (manufactured by Serum Institute of
India) to be distributed amongst prospective beneficiaries in the fight against COVID-19. This policy
overview tracks the lead up to Phase I of the vaccination drive, covering the formation of NEGVAC and
other nodal oversight agencies that have devised the framework for inoculation, the requirements for
licensing approval and the specifications of who would receive the doses and when and where they would
receive them. The paper also summarizes the results so far and what it might mean for India as the year
goes on.
1. Introduction
Even before the first case of the novel Coronavirus (COVID-19) was detected in the country, the
Government of India (GOI) began exploring preventive and curative measures to ensure effective
management of the pandemic. Starting with a series of travel restrictions, lockdowns, social-distancing,
sanitation and hygiene-related measures in March 2020, the government simultaneously expanded
infrastructure for testing and encouraged the scientific exploration of potential cures to the virus. With a
decline in rate of infection and a host of vaccine suppliers seeking emergency approvals for distribution,
the GOI began exploring vaccine distribution in November 2020. After a detailed process, carried out by
the Central Drug Standard Control Organisation (CDSCO), on 17th January 2021, the GOI announced
the implementation of a nation-wide COVID-19 vaccination drive, the world’s largest vaccination
program. The drive focused on inoculation via two government approved vaccines; ‘Covishield’ and
‘Covaxin’.
In this paper, I will be providing an overview of the GOI’s efforts towards curative solutions to COVID-
19, with a focus on the process of vaccine development, approval and plans for a nation-wide inoculation.
I will pay particular attention to the policy considerations, infrastructure concerns and levels of
organizational and federal control in this process.
2. Background and Vaccine Development
Following the enforcement and awareness dissemination of various preventive measures, from mask-
wearing etiquette to strict lockdowns, in July 2020 the GOI initiated the formation of a National Expert
Group on Vaccine Administration for COVID-19 (NEGVAC). Under the stewardship of the National
Secretary for the Ministry of Health and Family Welfare and a health expert from NITI AYOG, India’s
central policy planning body, NEGVAC sought a top to bottom, inter-department and expert view on
the nation’s vaccination plans. To appropriately represent diverse perspectives and create guidelines for
vaccine approval, inoculation and communication, the NEGVAC consulted with the Ministry of External
Affairs, Department of Biotechnology, Department of Health Research, Department of Pharmaceuticals
and the Ministry of Electronics and Information Technology. Additionally, the Director of General
Health Services, the Director of India’s leading public health Care provider, AIIMS Delhi, and
representatives from the National Technical Advisory Group on immunization (NTAGI) were also
involved in the process. (Ministry of Health and Family Services, 2020)
As an advisory and oversight committee, NEGVAC subscribed to the WHO mandated Vaccine
Development Stages, deciding to entertain approval requests once developers had completed Phase III of
Clinical Trials on an Indian population (having tested Vaccine efficacy on 30,000 to 50,000 willing
participants). In December 2020, the GOI compiled a list of 9 COVID-19 Vaccines being developed for
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Policy Brief Rudra Saigal
India, featuring various Indian manufacturers and scientific collaborators. Each of these identified
vaccines were across various stages of development.
Image 1: Vaccines being developed in India as of December 2020; Source: Department of Health and Family Planning
Simultaneously, in consultation with state government representatives, the NEGVAC began creating a
decentralised system of state level and district level oversight and planning bodies that were prepped and
briefed for effective implementation. Considering the planning, infrastructure, storage and
communication demands of a nation-wide vaccination campaign, the NEGVAC delegated a system of
responsibilities across state level Steering Committees which in turn would oversee state, block and
district level task forces and control rooms. The responsibilities for these organisations were divided into
two phases; i) Preparatory (pre-vaccine availability) and ii) Implementation (post-vaccine availability).
Image 2: The decentralized Vaccine Planning and Information structure, overseen by NEGVAC; Source: Department of
Health and Family Planning
Utilizing pre-existing positions of decentralized power, the NEGVAC was able to bypass systemic delays
to fast-track setting up a system for implementation at various levels. Additionally, the NEGVAC
formalized the vaccine roll-out process by enabling remote registration and delegation through digital
means. Digitalizing the database of administration, applicants and venues, the COVID-19 Vaccine
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Policy Brief Rudra Saigal
Intelligence Network (Co-WIN) was set up to register, identify, enlist and track beneficiaries of the
vaccine. Developing the network as a website and an application, the main aims of the Co-WIN are;
a. Creation of State and District level admins;
b. Creation of facility/planning unit databases;
c. Creation of vaccinator, and supervisor databases;
d. Manage material relevant to COVID-19 Vaccination and its allocation;
e. Creation of session sites;
f. Bulk upload of beneficiary data for registration;
g. Self-registration by general population;
h. Session management for linking session sites, vaccinators, supervisors, and beneficiaries;
i. Rights for viewing sessions and beneficiary allocated to these sessions for Block Admin and Facility
Medical Officer In charge; and
j. Monitoring and Reporting.
(Ministry of Health and Family Planning, 2020)
The early and formation and appointment of an expert, inter-department oversight body in the form of
the NEGVAC allowed the GOI to effectively use pre-existing structures of decentralized governance to
prepare for the eventuality of a COVID-19 vaccine, paving the way for other departments and bodies to
administer the approval process in a reasonable time.
3. Emergency Order and Approvals
Despite having relatively weak legal frameworks for drug development and regulation (Negi 2021), the
GOI has identified the laws that are essential to the process of drug development and distribution in the
country. Clinical trials in India are governed by the Drugs and Cosmetics Act, 1940, Medical Council of
India Act, 1956, Central Council for Indian Medicine Act, 1970 and the revised Central Drugs Standard
Control Organisation (CDSCO) Act, 2019.
The GOI appointed the Central Drugs Standard Organisation (CDSO) as the central planning and
regulatory authority on approvals and considerations, and the Indian Council for Medical Research was
asked to represent itself in ethics committees overviewing the trial process. Additionally, for developers to
gain permissions for Clinical trials, they were required to register with the ICMR, and gain permission
from the Drugs Controller General of India (DCGI). Each of the 9 vaccines identified by the NEGVAC
in the previous section underwent this process and were asked to keep the ICMR staffed ethics
committees updated with clinical trial data (PRS, 2020).
Fast-tracking the regular process in the face of an unprecedented pandemic, in December 2020, the GOI,
via the CDSO, began reviewing clinical trial data post the completion of Phase III trials. Four registered
manufacturers; Pfizer, Moderna, Serum Institute of India and Bharat Biotech applied to have their data
reviewed on an emergency basis. Of these applicants, the CDSO approved Serum Institute’s ‘Covishield’
and Bharat Biotech’s ‘Covaxin’ subject to certain regulatory conditions. While details about the approval
process are scantly available in the public domain, the CDSO revealed that approval for Serum Institute’s
‘Covishield’ was granted approval based on available global Phase I, Phase II, Phase III efficacy data and
bridging data focused on an Indian descent control group. The approval process for Covaxin in
particular, has been controversial as the manufacturers hadn’t completed Phase III trials at the time of
approval. Bharat Biotech’s MD, Dr. Krishna Ella shed some light on the process by revealing that the
government had that everyone who got shots of the Bharat Biotech vaccine would be treated as
“participants in an open-label clinical trial” (Vasudevan, 2021).
Upon gaining approval from the CDSO, both vaccine manufacturers were given dose requirements in
preparation of Phase 1 of the GOI’s implementation program, which began on 16th January 2021.
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Policy Brief Rudra Saigal
4. Implementation
The GOI negotiated an affordable rate for the acquired vaccines. Unlike other produced vaccines both
Covaxin and Covisheild can be stored between 2°– 6°C, requiring readily available cold storage
infrastructure. Both vaccines also require two doses to be given in order to successfully inoculate willing
citizens.
Based on the demographic statistics and population data, the GOI divided the population into groups,
based on which the vaccine roll-out is being implemented. The first of these groupings, Phase I of the
inoculation process, to be completed by August 2021, was reserved for three categories; a) Health Care
Workers b) Front line Workers and c) Prioritized Age group and people with comorbidities. Of these
groups, healthcare workers and frontline workers were to be inoculated free of cost. This accounts for
300 million people, or 20% of the nation’s 1.5 billion population. Within this, Health Care Workers
would be inoculated first, followed by Front Line Workers and the Prioritized Age Group would
complete the Phase I inoculations.
Image 3: Groups included in Phase I of the vaccination process which began on 16th January 2021; Source: Ministry of
Health and Family Planning
In order to effectively administer vaccines to the first of the three categories in Phase I, the government
acquired 11 million Covishield doses and 5.5 million Covaxin doses. As of 6th February (based on latest
available figures) approximately 5.7 million health care workers and frontline workers, of the planned 30
million, had been vaccinated.
As designed by the NEGVAC, the vaccination is being carried out in selected public and private
hospitals, with a combination of the two selected vaccines (Covaxin and Covishield) being sent to state to
be distributed at the district and block level. The allocation of vaccines is being carried out based on the
certain universal considerations. The standard calculations in use for estimation of total vaccines is
calculated by considering area covered, population inoculated and the potential wastage of doses based on
human error and infrastructure failures, such as cold storage, opened vials etc.
Thus, the number of COVID-19 vaccines required for 1 month = [(Total population to be covered in the
relevant catchment area (state/ district/ block/ sector) x % of population to be covered in this catchment
area/no. of months of the campaign) x 2 doses x WMF
Where WMF = Wastage Multiplication Factor = 1.11 for the COVID-19 vaccine, assuming an allowable
programmatic wastage of 10% [WMF = 100/ (100 – wastage) = 100/ (100-10) = 100/90 = 1.11)
Healthcare workers initiated the vaccine roll-out with heads of various hospitals publicising their first
dose to encourage others to turn out in big numbers. To enable safe, socially distant vaccination, the
NEGVAC divided Heathcare workers and Frontline workers into actionable chunks. 10 million health
care workers were divided in nine categories, based on role, specalization and area.
5Policy Brief Rudra Saigal
Image 4: Categories of Healthcare workers to be inoculated in Phase I; Source: Ministry of Health and Family Planning
The same process was followed with the 20 million Frontline workers, who were subcategorized based on
jurisdiction, specialisation and the ministry they reported to.
Image 5: Categories of Frontline workers to be inoculated in Phase I; Source: Ministry of Health and Family Planning
As the GOI works through these pre-decided categories, the Co-WIN app will soon be open for
registration of people falling into the vulnerable age group of 50+ and people with comorbidities.
5. Conclusion
India’s COVID-19 vaccination drive is set to be the largest ever in a nation. With a target of 1.5 billion
citizens, many challenges lie ahead as the roll-out moves forward. Despite having the third highest
vaccination number sin the world, as of 6th February 2021, the rate of inoculation in India was slowing
down. This can be attributed to certain kinds of vaccine hesitancy, whereby people are choosing to opt
out of the current drive in hopes for more efficient vaccines in the future.
However, India is better placed than other countries in terms of its falling COVID infection and death
rate, which continues to follow a downward trend. The GOI continues to communicate with beneficiaries
and hold regular meetings to tweak the delivery process.
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Works Cited
1) NDTV. ‘57 Lakh Get Coronavirus Vaccine Shots In India, 3rd Highest After US,
UK’. NDTV.Com, https://www.ndtv.com/india-news/coronavirus-57-lakh-get-covid-19-
vaccine-shots-in-india-3rd-highest-after-us-uk-2364980. Accessed 7 Feb. 2021.
2) Ministry of Health and Family Welfare, Government of India. Covid 19 Vaccine - Operational
Guidelines . Dec. 2020, p. 1-148.
3) Ministry of Health and Family Welfare, Government of India. Covid 19 Vaccine – Communication
Strategy . Dec. 2020, p. 1-148.
4) PRS. ‘September 2020’. PRSIndia, 1 Oct. 2020, https://www.prsindia.org/policy-
review/monthly-policy-review/september-2020.
5) Vasudevan Mukunth . ‘India’s Vaccine Approvals Had One Problem. It Gave Rise To the Other
Two.’ The Wire, https://thewire.in/health/indias-vaccine-approvals-had-one-problem-it-gave-
rise-to-the-other-two. Accessed 22 Jan. 2021.
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