This will be the world’s largest immunisation programme, where 30 crore Indians will be vaccinated.
NEW DELHI: In what is going to be the world’s largest immunisation programme ever carried out at one go, more than 30 crore, or about one-fourth of India’s total population will be administered Covid-19 vaccines. For this the Narendra Modi government has finalised an extensive, targeted strategy, which will be implemented with the active involvement of various levels of administrators and healthcare and other professionals—right from the top-most office of India to the ground level workers who will administer the Covid-19 vaccines to Indians in a phased manner.
To ensure that a humongous exercise of this nature is carried out without any glitch, the Union government has created a National Expert Group on Vaccine Administration for Covid-19 (NEGVAC) under the chairpersonship of Member (Health) NITI Aayog and Co-chairpersonship of Secretary (Health and Family Welfare), with representation from Secretaries from Ministry of External Affairs, Department of Biotechnology, Department of Health Research, Department of Pharmaceuticals, Ministry of Electronics and Information Technology and Director General Health Services, Director of AIIMS Delhi, Director NARI and representatives from NTAGI, Ministry of Finance and five state governments representing all the regions of India.
NEGVAC will be the nodal agency for guidance on all aspects of Covid-19 vaccine introduction in India, including regulatory guidance on vaccine trials, vaccine selection, equitable distribution of vaccine, procurements, financing, delivery mechanisms, prioritization of population groups, vaccine safety surveillance, regional cooperation and assisting neighbouring countries, communication, media response, etc.
Official sources say that a lot of homework has been done on the entire exercise, considering the scale of the exercise and the fact that something like this was happening for the first time in the country.
Under NEGVAC, 20 Union ministries are converging at the national level to support various aspects of Covid-19 vaccination. Each of these ministries has been given a separate role. International organisations, including the World Health Organization (WHO), UNICEF, UNDP, John Snow, Inc. (JSI), a US based-public health research and consulting firm, and Bill and Melinda Gates Foundation, too, are going to play important roles in the rollout of the vaccine.
“Right from training those who will administer the vaccine, to vaccine logistics, a lot of thinking has gone into it. A system has been put in place for effective tracking mechanisms at every step, ensuring field visits and desk review of data at national and state levels, monitoring of vaccination activities which will be done through daily evening meetings, standardized monitoring tools, mobile based apps and collation of real-time data from planning units to the national level. We have tried to ensure that no blind spot is left,” a senior health ministry official said.
HOW COVID-19 VACCINES WILL BE ADMINISTERED
TARGET POPULATION, PHASE 1 VACCINATION: The Covid-19 vaccine, once available in India, will be distributed in a phased manner so that the most needy and vulnerable get the vaccine before others. In the first phase, the government has targeted to vaccinate about 30 crore people, who will be further divided into three priority groups.
According to the “Covid-19 Vaccines Operational Guidelines”, an extensive 112 pages of guidelines prepared by the Ministry of Health and Family Welfare, the first phase of vaccination will focus on healthcare workers, frontline workers and high-risk population groups.
While about one crore health care workers will be targeted in the first phase, approximately two crore frontline workers have also been identified for vaccination in the first phase. The first phase will also include the immunisation of around 27 crore people from the prioritised age group.
The high-risk population group will consist of people above the age of 50 years. The Ministry has further divided this high-risk population into two groups where the first priority under this group will be the population who are above 60 years of age. The next target population will be people of 50 years and above and those who have co-morbidities such as diabetes, cancer, hypertension, lung diseases, etc.
Healthcare workers would consist of medical professionals working in the field of healthcare, both at private and public healthcare institutions—including nurses, paramedics, support staff and medical students and ICDS workers.
Frontline workers would consist of all the three wings of the Indian Army, the paramilitary forces, municipal workers and state police personnel.
The government has decided to prepare the list of names from the prioritised age group using the latest electoral rolls of the Lok Sabha and Legislative Assembly elections in each state. The age will be calculated based on the cut-off date of 1 January 2021 and anyone born on or before 1 January 1971 will be in this category.
Respective state governments and the ministries concerned have been given the responsibility to collect the data of healthcare and frontline workers and to upload them on a dedicated website for this activity, www.cowin.gov.in. This digital platform will keep the relevant data updating in real time. A mobile application is also going to be introduced through which individuals will register themselves for the vaccine; this will also authenticate their identity and record their identity once they have got the vaccine.
The target population, who will be registered for the vaccination, will receive an SMS on their respective mobile numbers, which would inform them about the address of the vaccination centre and the time slot they have been given for their vaccination.
ADMINISTRATION OF VACCINES: A state steering committee headed by the Chief Secretary with the convener being the Principal Secretary, Health and a state task force for Immunisation headed by Additional Chief Secretary/Commissioner/Principal Secretary, Health and the Member Secretary being the state Immunisation Officer (SIO), has been created in every state and Union Territory to implement the vaccination programme.
A State Control Room, too, is going to be set up which will have a 24×7 telephone helpline.
At the district level, a District Task Force (DTF), consisting of the District Magistrate, District Immunisation Officer (DIO) and Chief Medical Officer (CMO), has been created. At the block level, a Block Task Force (BTF), consisting of Sub-Divisional magistrate/Tehsildar/BDO and the Block Medical Officer, too, has been put in place.
The required training for vaccination officer, supervisors, cold chain handlers, data entry operators, medical officer and programme, which usually takes 3-4 months to be completed, has been fast-tracked so that it can be done within 3-4 weeks.
For the administration of the vaccine, vaccination centres will be created at every district in the country and will be headed by the respective District Collectors. The vaccination site would consist of healthcare centres, schools, colleges, community halls, municipal halls, marriage halls, panchayat bhavans, railway hospitals and such other places.
Keeping in mind the difficult terrains in different parts of the country, the government has also prepared to deploy special mobile vaccination teams at those places where it is otherwise difficult to reach and set up vaccination centres.
The entire process of vaccination has been prepared in a way similar to the election process that the country undergoes. Each vaccination centre will be managed by a five-member team.
This five-member team will consist of a vaccinating officer who will be a doctor and will legally authorised to administer an injection. Another member will be vaccinating officer 1—either a police official, Home Guard, civil defence personnel or similar—who will be responsible for pre-checking the registration of the beneficiary along with their photo ID before letting them into the vaccinating centres. Vaccinating officer 2 can be anyone from the ICDS, health or government department and will be responsible for authenticating the documents of the beneficiary as uploaded in the Ministry’s vaccination site. Vaccinating officers 3 and 4 will be responsible for crowd management, guidance and monitoring symptoms.
The government will also appoint a supervisor for every three to five vaccination centres for effective coordination and management of these centres.
According to “Covid-19 Vaccines Operational Guidelines”, each vaccine site will vaccinate about 100 people each day and the vaccination time will be between 9 am and 5 pm based on the list created by respective district offices.
The Ministry has also given a detailed layout of how the vaccination site will look, once the vaccination process starts. According to the layout plan of the vaccination site, each site will have three demarcated rooms—waiting room, vaccination room and observation room.
Each room is advised to be well lit and ventilated, with preferably two doors and ensuring that social distancing is maintained.
The waiting room will consist of people seated before their vaccination and get their documents verified, while the vaccination room will be the place where one will be vaccinated and according to the guidelines, the vaccination room will be a place where secrecy is maintained and will be well-partitioned.
The third room will be the observation room, where people who have been vaccinated will be seated for at least 30 minutes to ensure that no adverse reaction is observed in anyone. And those who experience adverse reactions will be given medical attention immediately.
Once vaccination is completed, the candidate who has received the vaccination, will be sent an SMS on his/her mobile phone with a link through which they will be able to download the vaccination certificate.
Each vaccine site will have the following items: 1. Three printed copies of beneficiary list (wherever feasible); 2. Vaccine carrier with ice packs and additional vaccine carrier; 3. Adequate Covid-19 vaccine; 4. Adequate numbers of AD syringes and reconstitution syringes (if needed); 5. Hand sanitizer and masks; 6. Vaccine vial opener; 7. Hub cutter; 8. Screen for privacy (if room is not separate); 9. Anaphylaxis kit; 10. Red, yellow and black bags, puncture proof blue container, waste basket; 11. Cotton wool; 12. Tally sheet, IEC material, hand washing facilities
LOGISTICS RELATED TO THE VACCINE
The vaccines that are currently under development and those already available will require a robust cold chain for their effective transportation. Keeping this in mind, the government and the Ministry of Health and Family Welfare have brought out a detailed guideline on cold chain management and the method through which the vaccine will be distributed in the country.
Certain vaccines that have been developed or are under development require a cold chain facility, ranging from 2 degree Celsius to -80 degree Celsius.
Multiple cold chain equipment has been identified for the effective storage and distribution of Covid-19 vaccines. Electrical cold chain equipment will be used for the storage of the vaccine at the regional level, while non-electrical cold chain equipment like cold boxes and vaccine carriers will be used at the vaccination centres for the effective storage of the vaccine.
As per ministry officials, a total of 28,932 cold chain points are available across the 36 states and Union Territories in India, while a total of 310 walk-in coolers and freezers together are available and 44,226 ice-lined refrigerators, 40,792 deep freezers and 294 solar units are available with different states and Union Territories.
For transportation, the vaccines will be placed in insulated vaccine vans with all vaccines stored in cold boxes packed with the required number of conditioned ice packs.
The Ministry has also advised officials to ensure that all measures are taken to avoid exposing the vaccine carrier, vaccine vials or ice packs to direct sunlight and the vaccines and diluents should be kept inside the vaccine carrier with the lid closed until a beneficiary comes to the centre for vaccination.
“There may not be VVM (Vaccine Vial Monitors) and Date of expiry on the label of Covid-19 vaccine; this should not discourage vaccinators from using the vaccine. The vaccinator should take out one ice pack from the vaccine carrier to place the Covid-19 vaccine on the ice pack (in case the Covid-19 vaccine is very heat sensitive) or keep the Covid-19 vaccine on the table (in case the vaccine is not very heat sensitive). At the end of the session, the vaccine carrier, with all ice packs and unopened vaccine vials, should be sent back to the distributing cold chain point,” the guidelines state.
Apprehending that there could be some leakages of the vaccine during transportation and storage at the cold chain storage, the Ministry has also advised the state to ensure that there is no such leakage. Each district has to also update the vaccine stock records on a daily basis in the centralised vaccine monitoring system developed by the Central government.
COVID-19 VACCINE INTELLIGENCE NETWORK (CO-WIN)
Co-WIN has been developed as an extension of the existing electronic Vaccine Intelligence Network (eVIN) module for it to be a comprehensive cloud-based IT solution for planning, implementation, monitoring, and evaluation of Covid-19 vaccination. The Co-WIN system is an end-to-end solution that utilities the entire public health system from the national level to the level of the vaccinator. The system allows for the creation of users (admins, supervisors, vaccinators), registration of beneficiaries (bulk upload and individual registration), facilities or planning unit and session sites followed by planning and scheduling sessions and implementation of vaccination process. The Co-WIN system on a real-time basis will track not only the beneficiaries, but also the vaccines, at the national, state and district levels. This will allow the system to monitor the utilization, wastage, coverage of Covid-19 vaccination at the national, state, district and sub-district levels.
The Covid-19 vaccine will be provided only to beneficiaries pre-registered in Co-WIN. The general population can also get themselves registered for vaccination on this website by providing his/her demographic details like name, date of birth, permanent and current address and details of co-morbidities, if any. The individual interested to register her/himself will be required to provide her/his photo identity in PDF, JPG or PNG format on the website.
ADVERSE EVENTS MONITORING SYSTEM
Since there is limited data available on the safety of Covid-19 vaccines, the government has also prepared itself for adverse reaction monitoring and addressing systems in case anyone, who has been administered a vaccine, faces any issue.
An adverse event following immunisation (AEFI) is an untoward medical occurrence which follows immunisation, and may not be necessarily directly related with the usage of the vaccine. The adverse event may be any unfavourable or unintended disease, symptom, sign or abnormal laboratory finding. Reported adverse events can either be true adverse events, which are actually a result of the vaccine or immunisation process, or coincidental events that are not due to the vaccine or immunisation process but are temporally associated with immunisation.
The AEFI can be categorised into minor, severe and serious; where minor symptoms could include the common side effects like pain, swelling at injection site, fever, irritability, malaise etc., while Severe AEFI could include some disabling and rarely life-threatening symptoms that do not lead to long-term problems like severe reactions include non-hospitalised cases of anaphylaxis (severe allergic reaction) and high fever. The more severe AEFI could include symptoms like persistent or significant disability requiring hospitalisation and sometimes death.
Keeping in view such a situation if it arises at all, the Ministry has prepared a broad guideline to handle any such cases. The guideline says that vaccinators and supervisors at the vaccination site will provide primary treatment of all AEFIs. If needed, cases should be immediately referred to the nearest AEFI management centre/health facility and reported to the appropriate authority.
The guideline further says that all beneficiaries must be counselled about adverse events which may occur after Covid-19 vaccination. These are expected to be minor events such as local pain and swelling and mild to moderate fever, etc. In case of any type of discomfort or illness following Covid vaccination, the vaccine recipient should visit the nearest health care facility for treatment. At fixed session sites, an AEFI management kit or an emergency tray should be available for use.
Anaphylaxis kits are also to be present at the vaccination sites and all vaccinators must be trained to suspect signs and symptoms of anaphylaxis and to use the contents of the anaphylaxis kit to provide a single, age-appropriate dose of injection, adrenaline and arrange transportation of the patient to the nearest AEFI management centre/hospital for further treatment. This is crucial for saving lives in case of rare but life-threatening anaphylactic reactions. It has also been advised to keep adequate transportation to transfer persons with serious adverse reactions to the nearest identified AEFI management centre or health facility.