A vaccine for Covid-19 is knocking on India’s doors. On Wednesday, December 30, the U.K. gave the go ahead to the AstraZeneca-Oxford Covid-19 vaccine. It is believed, India will approve the vaccine soon, after the U.K. regulator, Medicines and Healthcare products Regulatory Agency (MHRA), gave the nod for emergency use authorisation. In India, the vaccine is called Covishield and it is being manufactured by the Pune-based Serum Institute of India. In fact, the country has already begun a dummy vaccination drive in a few states, to prepare for an eventual roll-out, touted as the most ambitious mass immunisation programme in the country’s history.
In India the nod for the vaccine has to come from the regulator, the Drugs Controller General of India (DCGI). “The expert committee is trying its best to approve the vaccine at the earliest. However, they have to complete safety profiling with efficacy and stability of the system,” a source at the DCGI says.
But when will the vaccination drive begin? According to sources, it could start as early as mid-January. Besides Covishield, the vaccine candidates of Pfizer BioNTech and Bharat Biotech (Covaxin) have also applied for emergency use authorisation in India.
How prepared is India for the massive vaccination drive? Fortune India accessed government documents to examine in detail the structure of the mechanism to roll out the vaccine. The Government of India set up the National Expert Group on Vaccine Administration for Covid-19 (NEGVAC)—headed by member (health) NITI Aayog V.K. Paul—to prepare a plan for the roll-out of the vaccine. The secretary (health and family welfare) is also a part of the body.
Tasked with ensuring the vaccine reaches the grassroots level, NEGVAC also has representation from 20 ministries of the Government of India, including the secretaries from the Ministry of External Affairs, Department of Biotechnology, Department of Pharmaceuticals, Ministry of Electronics and IT, Ministry of Finance, and the state governments. The Director General of Health Services, director, National AIDS Research Institute (NARI), and the director of the All India Institute of Medical Sciences (AIIMS) are also part of the body.
NEGVAC's aim is to guide all aspects of introduction of the Covid-19 vaccine, including regulatory guidance on trials, vaccine selection, distribution, procurement, financing, delivery mechanisms, prioritisation of population groups, safety surveillance, communication and media responses. It is also responsible for regional co-operation and helping neighbouring countries implement the roll-out.
The state of preparedness
At the state level is the state steering committee, chaired by the chief secretary and convened by the principal secretary, health. More than 19 government departments are part of the team, including paramilitary and defence establishments. There are also more than 10 development partners from civil society including WHO, UNICEF, UNDP, John Snow India, and the Bill and Melinda Gates Foundation, etc.
Till the vaccine is made available, the state governments are training their personnel. A database of healthcare workers is also being prepared using the digital database Co-WIN in phase 1 of the roll-out.
The responsibilities of the state steering committee include coordination, identification and deployment of human resources with expertise in medical/health for vaccination, while other staff are being identified for operational support, IEC (information, education, communication), resource mobilisation as well as community mobilisation.
Work is also on for cold-chain preparedness, operations planning, communication planning, strategies for state-specific challenges in terms of geographical terrain, network connectivity, and accessing hard to reach areas.
The job of the state steering committee includes financial planning for the introduction of the vaccine among priority groups, including CSR for financing activities related to Covid-19.
The state may also use common service centres (CSC) and other public infrastructure as well as direct the planning of the state and district task forces. A significant job is to ensure that state and district adverse event following immunisation (AEFI) centres are set up and strict surveillance is conducted.
Once the vaccine is available, the state steering committee will begin micro-planning the roll-out with different departments. This will include storage, transportation and delivery under police protection and encouraging districts to plan for an efficient and smooth vaccination programme, with proper monitoring of AEFI.
Each state has set up a State Task Force (STF) for immunisation under the commissioner/principal secretary of health or additional secretary, and will have as members the mission director of the National Health Mission, along with implementation officials and civil society working in the healthcare space. The task force has already listed the beneficiaries in the first phase and have given their guidance on vaccine introduction. It is also reviewing cold-chain preparedness and identifying and training vaccinators without disrupting routine immunisation.
The planning and mapping of vaccination sessions in coordination with the district authorities and AEFI surveillance will be done with urban and rural local bodies.
The state control room will operate 24x7, with a clear chain of command, communication, and accountability framework.
At the district level, the task force is headed by the district magistrate and has the district immunisation officer and chief medical officer on the team, along with members of key departments. Their key duties include identifying vaccinators, session planning, and beneficiary identification, along with surveillance of AEFI.
Similarly, there is an urban task force, chaired by the municipal commissioner and a district/municipal control room. At the block level, there is a block task force under the sub divisional magistrate, tehsildar or block development officer with a block control room.
A total of 20 ministries are involved in the planning and implementation of the roll-out with WHO, UNICEF, UNDP, Bill and Melinda Gates Foundation and John Snow Foundation in India.
All in all, India seems ready with a framework for vaccine deployment.