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Over a Billion COVID-19 Vaccine Doses: How Did India Do It?
Ananya Chakraborty
Vydehi Institute of Medical Sciences & Research Centre

anuary 16, 2022, was a proud day for India. The country achieved the milestone of completing one year of the world’s largest vaccine drive and celebrated delivering 1.56 billion COVID-19 vaccine doses in the previous year. The health ministry reported upon the completion of this year-long drive that most adults (93%) had received their first COVID-19 vaccine dose, and more than 77% of the adult population had been fully vaccinated. More than half (52%) of children in the permissible age group (15 to 18 years) have received their first dose. One might wonder: How did India do it?

It started with the planning at a national level. The challenges included developing an effective vaccine (R&D), deploying production to distribution (requiring effective collaboration and communication among stakeholders from the pharmaceutical industry and setup facilities), prioritization, administration, and most importantly: trust, confidence, and acceptance from beneficiaries. How did India overcome these challenges?

Scientific and epidemiological evidence, WHO guidelines, and global best practices built the framework. The vaccination program incorporated recommendations from experts in the field of immunization, public health, disease control, and information technology, and was supported by the United Nations Development Programme (UNDP). Various stakeholders proactively strengthened this program, and the government of India set up expert groups to plan and oversee various aspects:

  • A task force headed by the Principal Scientific Adviser to the Government of India was created to encourage domestic R&D of COVID-19 drugs, diagnostics, and vaccines.
  • The National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) was constituted to formulate a comprehensive action plan for vaccine administration. It was co-chaired by the National Institution for Transforming India Aayog (NITI Aayog), the apex public policy think tank of the Government of India, and Union health secretary.
  • Committees were formed, under the umbrella of NEGVAC, at the state level (State Steering Committee, State Task Force, State Control Room), district level (District Task Force, Urban Task Force, District/Municipal Control Room), and block level (Block Task Force, Block Control Room).
  • The central government also set up an empowered group on COVID-19 vaccine administration to facilitate optimal utilization of technology to make COVID-19 vaccination all-inclusive, transparent, simple, and scalable.

What other factors led to the success of India’s vaccination program?

  1. Public-private partnership: The first indigenous vaccine was a result of public-private partnership. The vaccine was developed following the successful isolation of the SARS CoV-2 virus at the Indian Council of Medical Research (ICMR)-National Institute of Virology (NIV). ICMR entered into a public-private partnership with Bharat Biotech International Limited (BBIL) to develop the isolated virus into an effective vaccine candidate. Completing development in less than eight months was possible due to teamwork between various stakeholders and expedited approvals from regulatory authorities. The vaccine was developed on the WHO pre-qualified Vero cell platform. Pre-clinical studies were conducted on small animals, hamsters, and rhesus macaques. Phase 1 and phase 2 clinical trials, conducted in 755 participants, demonstrated the candidate vaccine’s high safety profile, with seroconversion rates of 98.3% and 81.1% on days 56 and 104, respectively. Preliminary phase 3 trial results have demonstrated an 81% efficacy rate. The phase 3 trial studied 25,800 volunteers across 25 sites in India. Thus, it is India’s largest clinical trial of a COVID-19 vaccine ever conducted.
  2. Integrated platform for vaccine supplies and storage: Identifying beneficiaries and a vaccine distribution network were made possible by the electronic Vaccine Intelligence Network (eVIN) in India. eVIN is an indigenously developed technology that digitizes vaccine stockpiles and monitors the temperature of the cold chain through a smartphone application. It was first launched in the country in 2015 and fortunately provided a ready-made stable platform. In association with the UNDP, eVIN helped maintain an error-free record of vaccine supplies and storage. UNDP also helped set up well-trained human resources, efficient functional and operational guidelines, and a system to check and resolve ground-level issues. This ensured adoption, adherence, and coordination across stakeholders in every state and union territory.
  3. Communication strategy: Communication strategy, based on the learnings of previous national immunization campaigns (Mission Indradhanush/Intensified Mission Indradhanush/Measles Rubella), was another important aspect of this successful vaccination program. The communication strategy had five key elements: advocacy packages, capacity building, media engagement, community engagement, and standard operating procedures for Adverse Events Following Immunization (AEFI) crisis management and communication.
  1. A National Media Rapid Response Cell (NMRRC) was established to capture the pulse of discussions about vaccines and their safety across India. NMRRC extensively and constantly monitored topics (and rumors) related to vaccine eagerness, vaccine hesitancy, and any misreporting or false information regarding vaccination. Vaccine advocacy packages included printed leaflets and factsheets; interviews, discussions, and opinion pieces by scientific experts and other credible voices; and multimedia materials, all translated into specific local languages.
  1. Digital platform to track vaccination: The government also launched the unique citizen-centric Co-WIN (COVID-19 Vaccine Intelligence Work) portal to effectively manage registering for vaccine appointments, administering the vaccine, and generating certificates of vaccination throughout India.
  1. There were worries of a “digital divide” because most of rural India lacks infrastructure, internet technology, and smartphones, compared to their urban counterparts. But the government created an accessible, inclusive system for people to register for their vaccines through common call centers (Panchayat headquarters) and other call centers set up for this purpose and allowed four different people to register from one mobile device.
  1. After rollout, a new policy also enabled third-party integration in the registration process implemented through the application programming interface of the Co-WIN platform. Third-party applications offered vaccination services directly to patient consumers (B2C) or to private vaccination centers (B2B). These applications streamlined the registration and vaccination processes and offered additional features such as sharing vaccination certificates to stakeholders during travel.
  1. Awareness campaigns included a vaccine mobile call line which delivered pre-recorded messages urging the caller to trust the safety and disregard rumors about the COVID-19 vaccine. Public spokespersons were trained, and press releases and conferences were carefully planned, in advance.
  1. Vaccination drives conducted at housing or office complexes, religious compounds, community halls, and other locations outside of traditional healthcare organizations also increased the speed of vaccination. Mobile vaccination vehicles were also employed, and rural delivery challenges were addressed by door-to-door visits.
  1. Monitoring of AEFI: The government strongly put forward an active COVID-19 vaccine surveillance process. Guideline documents included plans for AEFI surveillance and management through the Co-WIN portal. A vaccine beneficiary was to be observed by the vaccination team for 30 minutes after vaccination for immediate AEFI. Guidelines suggested updating AEFIs through VigiFlow. Suspected nonserious reactions could be reported on the Adverse Drug Reaction (ADR) reporting form in the form of ICSRs through VigiFlow. Suspected serious reactions should be reported to the Pharmacovigilance Programme of India (PvPI) through ADR forms submitted through VigiFlow, and also by email to the National Coordination Centre (NCC)-PvPI after submitting the AEFI case notification form.
  1. The PvPI issued circulars to Adverse Drug Reaction Monitoring Centers (AMC) at various healthcare organizations to guide their active monitoring and reporting of vaccine-related AEFI.
  1. AMCs were also directed to report the suspected reaction cases to the District Immunization Officer (DIO) or State Expanded Programme on Immunization Officer (SEPIO). Multidisciplinary AEFI committees were established at the local, state, and national levels to review causality assessment, and shared their data through the ministry of health and welfare website on a regular basis.
  1. Emergency use authorization and vaccine rollout: Two COVID-19 vaccines, each in phase 3 clinical trials at the time, received emergency use authorization in India on January 3, 2021: Covishield,TM AstraZeneca’s vaccine manufactured by the Serum Institute of India; and Covaxin,TM manufactured by Bharat Biotech Limited, India.
  1. After this authorization, the Ministry of Health and Family Welfare, India, led a three-phased vaccine rollout starting on January 16, 2021: In the first phase, CovishieldTM was made available for people at highest risk of exposure, such as healthcare and front-line workers, for whom CovaxinTM was added later. The second phase, vaccinations for persons with comorbidities age 45 and older and for everyone age 60 and older, began in March 2021. In April 2021, this was expanded to cover all patients age 45 and above (with no comorbidities). The third phase began in May 2021 with vaccinations for the age group 18 to 45.
  1. The vaccination drive for children in the 15-18 age group began January 3, 2022 with CovaxinTM.
  1. Clinical trials and fast-track approvals: In a major shift in vaccine approval policy, and based on recommendations from NEGVAC, the government decided to fast-track approvals for COVID-19 vaccines developed outside India and vaccines that received EUA by other drug regulatory agencies to hasten the pace of vaccine coverage in the Indian population. This fast-track approval process required bridging studies (in 100 beneficiaries monitored for safety outcomes for seven days) to take place in parallel with public vaccination.
  1. During the past year, eight COVID-19 vaccines were approved for use in India in addition to CovaxinTM and CovishieldTM.
  1. Allocation of vaccines and free vaccination policy: The Central Government allocates vaccines to each State based on population size, level of disease, vaccination progress, and vaccine wastage. The Central Government procures 75% of all vaccines manufactured in the country and provides them free of charge to beneficiaries at government hospitals and primary healthcare centers.
  1. Recently, India became the first country to administer the painless, needleless DNA ZyCoV-D vaccine, the second home-grown vaccine to receive EUA. An innovative intranasal vaccine is also being researched in a clinical trial.
  1. It would have been impossible for India to reach this vaccination milestone without such a highly coordinated approach. As we move toward WHO’s strategy to achieve global COVID-19 vaccination by mid-2022, we hope these efforts will hasten the weakening and fading of the pandemic.