About the author: Dr. Sai Krishna Gudi is a Ph.D. student at the College of Pharmacy, Rady Faculty of Health Sciences, University…
Authors: Sanjeev Kumar1 Anand Kumar2 Dr. Maryam3
Vaccination against COVID-19 is one of the critical tools to fight the Ongoing pandemic. Globally, It began on 31st December 2020, when WHO issued an Emergency Use Listing (EUL) for the Pfizer vaccine. In India, the Central Drugs Standard Control Organization (CDSCO), a regulatory body, has provided emergency use authorization to Covishield (AstraZeneca’s / Serum Institute of India) and Covaxin (Bharat Biotech Limited) on 3rd January 2021. Later, On 15th April 2021, the Government of India (GoI) provided restricted emergency approval to vaccines approved by US FDA, EMA, UK MHRA, PMDA Japan, or listed under WHO EUL. Under which, Sputnik – V has been granted EUA in April 2021. The Zydus Cadila vaccine for 12-18 years has also been received EUA on 20th August 21.
Vaccine Introduction is a complex process that needs careful planning to ensure the requisite infrastructure and technical support. The GoI issued COVID 19 Operational Guideline, considering the WHO advised Interim Guidance on developing a national deployment and vaccination plan for COVID-19 vaccines, on 28th December 2020. This Guideline provided architectural navigation for the Covid 19 Vaccination drive when it introduced pan India on 16th January 2021.
Regulatory Preparedness: National Disaster Management Act, 2005 was imposed in India to deal with the Covid Pandemic. Through this act, the GoI constituted multiple Empowered Groups with specific objectives. The Central Drugs Standard Control Organization was established as a regulatory body to approve new vaccines/drugs, clinical trials, import registration, licensing, and market surveillance. In August 2020, the GoI constituted the National Expert Group on Vaccine Administration for COVID-19(NEGVAC) at the national level to provide stewardship to the vaccine introduction. It includes regulatory guidance on vaccine trials, selection, equitable vaccine distribution, procurements, financing, delivery mechanisms, prioritization of population groups, vaccine safety surveillance, regional cooperation, communication & media response. A State Steering Committee (SSC) was formed to provide stewardship for Covid 19 vaccine introduction. To monitor the Vaccine introduction activities in State, District, Block, and urban settings, Taskforce was also established ( Please refer to Figure 1 COVID19 Vaccination, Administrative Framework).
Fig-1. COVID19 Vaccination, Administrative Framework
Planning and Coordination:
NEGVAC is the apex body that does all the planning at the national level and coordinates with State Steering Committees. The State Steering committee does the planning and coordinates with the State task force and control room. The state task force coordinates with the district task force and supports the district in planning & so on.
Costing and Funding:
The GoI has budgeted INR 35,000 Crores for COVID-19 vaccination in FY 2021-22 for free vaccination for the eligible cohort. Additionally, the Prime Minister’s Citizen Assistance and Relief in Emergency Situation fund (PM CARES) have contributed around 2200 Crores INR during the first vaccination phase. On 1st May 2021, the GoI implemented the “Liberalized Pricing and Accelerated National COVID-19 Vaccination,” in which the GoI provided 50% of the vaccine doses free of charge to the State, while the remaining 50 % was allocated to the State and private sectors through direct purchasing from the manufacturers. On 7th June 2021, The GoI revised the strategy and adopted “One Nation – One Price – One Vaccine Buyer” and introduced free Cost Vaccines to the eligible cohort.
Identification of target populations:
To ensure optimal use of available vaccines, On 13th November 2020, the WHO developed a Roadmap For Prioritizing Uses of Covid 19 Vaccines in the context of limited Supply. India embarked on the same strategy and divided the covid vaccination drive into phases. In the 1st phase, three priority groups were included: Health Care Workers (HCWs), Frontline Workers (FLWs), and the Population to 50 years of age and above and younger than 50 years with co-morbidities. In the early second phase, the population above 45 years of age having co-morbidities was prioritized; later, it extended to the entire population with 45 Years and above. On 1st May 2021, 3rd phase began for the people who are above 18 Years.
Vaccination Delivery strategies:
Covishield and Covaxin are both required to inoculate two doses. The time interval between the two doses for Covishield is 16-18 Weeks, while for Covaxin, it is 4 Weeks. For Vaccine delivery, the GoI had decided to use the Universal Immunization Program delivery framework.
Preparation of Supply chain and management of health care waste: India developed a COVID -19 Vaccine Intelligence Network (CO-WIN), an IT solution, an end-to-end solution for COVID 19 vaccination planning, implementation, monitoring, and evaluation. Apart from creating admins at Union, State and Districts, this platform creates databases for facilities/ planning units; Vaccinators and, Session sites. CO-WIN crashed multiple times, which led to holding the registration, but later multiple registration methods have been introduced, like through WhatsApp, Aarogya Setu App, and onsite.
Human resource management and training:
GoI identified and planned human resources in three categories: Vaccination officer 1 to 4 Vaccinator officer, and Supervisor. For capacitation of these workforces, multiple strategies were implemented, including the Use of Virtual training methods, traditional classroom training, Self-learning module to complement instructor-led training.
Vaccine acceptance and uptake (Demand): Aligned with WHO advised steps to increase vaccine acceptance, MoHFW developed Communication Strategies. The strategies include Vaccine information; Advocacy at National, State, and District; capacity building of crucial Stakeholders; Strengthening Mass Media, Social Media, Social Mobilization, and Community Engagement; Managing Crisis Emerging from AEFI; Monitoring & Evaluation, Documentation, and Knowledge Management. Despite these strategies’ implementation, a large proportion of the Indian population faces vaccine hesitancy.
Vaccine Safety Monitoring, Management of Adverse Events following Immunization (AEFI) and Injection Safety: To ensure robust pharmacovigilance, India had in place the National AEFI Surveillance and Response Guidelines for Immunization. Considering the new vaccination program in campaign mode, the MoHFW has made it mandatory to observe the beneficiary for 30 Minutes after Vaccination to detect the AEFIs. Until August 2021, India reported 0.006 % of AEFI cases reported against a total of 64,16,49,680 administered doses.
Conclusion: India took the first concrete step towards COVID 19 vaccine Introduction with the constitution NEGVAC in August 2020. Early preparations enabled the Government to initiate the vaccine inoculation in mid-January 2021, at the population level. Initially, vaccine wastage and the shortage have decelerated the vaccination drive significantly. Despite the interventions to reduce vaccine hesitancy, It is still a significant challenge to the vaccination drive. Target-based culturally appropriate with robust monitoring framework led Interpersonal Communications could be instrumental in fastening the COVID19 Vaccination across India.
Sanjeev Kumar1 works with the Health Systems Transformation Platform (HSTP) in Research Specialist Capacity. He has worked with multiple State Health Systems in India.
Anand Kumar2 Public Health professional. He has extensively worked in strengthening MCH Services and Urban health in Bihar, India.
Dr. Maryam Monir3 is IMPH Fellow at Tsinghua University, Beijing, China.