300 million target in Phase I: How will India’s COVID-19 vaccination plan work?

Kolkata: Back in the last week of March, 2020, India were subjected to what was termed as the ‘largest lockdown’ in the world. Nine months down the line, there seems to be light at the end of the tunnel as the world’s second-most populous country readies for what could be the biggest immunisation programme yet against COVID-19 virus.

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In a significant announcement on the last day of a traumatic year, the Indian Health Ministry announced that all states will be conducting a dry run of the vaccination programme on Saturday (January 2) in all state capitals in at least three session sites. This exercise is in line with a two-day dry run conducted on December 28-29 in Andhra Pradesh, Gujarat, Punjab and Assam to test the readiness of the mechanism and take feedback on how such a humongous exercise could be conducted in a country with a population of 1.3 billion throughout 2021.

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The challenges of the initiative, under which 300 million people will be vaccinated in the first phase by July, is a daunting one – to say the least. If the endorsement of two of the main vaccine candidates: Serum Institute of India’s ‘Covishield’ and Bharat Biotech’s ‘Covaxin’ is the news the country is waiting to hear, the bigger hurdle will be identification of the groups who would require the vaccine and gain access to them.

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Any vaccine has to be administered in two to three doses, spaced out over a gap of three to four weeks, and the dynamics of a country like India makes it doubly difficult to complete the dosages and follow up on any possible side effects.

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Who needs a vaccine?

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The Indian Health Ministry has done its number-crunching among their initial target of 300 million and prioritised the groups as follows:

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Healthcare Workers (government and private): 10 million

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Frontline workers (personnel from state and central police department, armed forces, home guards, civil defence organisations including disaster management volunteers and municipal workers): 20 million

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Priority age groups: 270 million (above the age of 50 years and less than 50 years with comorbidities)

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Co-WIN, the app at the heart of the drive

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The states and Union Territories have collected the data from both government and private healthcare facilities from their platforms and are uploading them on digital platform ‘Co-WIN,’ an app which will be at the heart of the vaccination drive.

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CoWIN (COVID-19 Vaccine Intelligence Network) is a re-purposed version of eVIN (Electronic Vaccine Intelligence Network), an indigenously developed platform in partnership with the United Nations Development Programme (UNDP) and the Ministry of Health and Family Welfare.

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The ministry, in partnership with the UNDP, has been running the Universal Immunisation Programme through eVIN since 2015. Its functions include digitisation of vaccine stocks and offering real time monitoring of cold chains through an app.

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Over the last five years, eVIN has digitized stocks in 27,000 vaccine storage centres across all districts of 29 states and seven union territories in the country. It also monitors storage temperatures of nearly 50,000 temperature loggers. These capabilities should come in handy as the platform is now re-purposed for the COVID-19 vaccination drive. Data collection for the first round of the vaccination drive has already begun.

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The Co-WIN beneficiary management platform will help track the beneficiary, vaccination session planning and management. Within the beneficiary management platform, there is an administrator module – one can create a vaccination session with details of how many people could be vaccinated together in one day in one block and place and time and who will be the vaccinator.

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Registration module: One can also register at common service centres at the block level. Managers can also upload bulk data. Vaccination details can be verified when the dose was given and when the second dose is to be given.

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Beneficiary acknowledgement: A certificate to be given with QR code after vaccination, tracking of dropouts as well. Sessions planned vs sessions held report will also be monitored.

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How will the vaccines reach the states?

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An umbrella body, the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) has been formed for the purpose, which will oversee the work done by each state’s steering committee for vaccine distribution. The state committee will be led by it’s state Chief Secretary and a state-level task force will be led by the Principal Secretary (Health) which shall look at logistics and human resource management.

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States will also have a control room that will work 24/7 when the process of vaccination begins. The district-level task force will be led by the district collector and urban task force for big municipal corporations such as Mumbai, Pune, Chennai etc will have an urban task force chaired by the municipal commissioner. Around 96,000 vaccinators have been trained for the vaccination programme throughout the country.

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Asked about their state of readiness, Riten Roy Chowdhury, Health Commissioner of West Bengal government told Gulf News: ‘‘The spadework is being done from December and we are in sync with the Union Health Ministry’s guidelines. The country has been witnessing a steady decline of cases since September – which will help us narrow down our focus in building the data.’’

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The Vaccine options

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There is a distinct change in the mood of the country from August-September, with December recording the lowest number of new infections in six months and the light and the vaccines looking to be round the corner. A government-appointed panel of experts met on Friday to consider requests for emergency use approval of two contenders: ‘Covishield,’ developed by Oxford University and pharma major AstraZeneca and being manufactured by the Serum Institute of India and ‘Covaxin’ developed by Bharat Biotech along with the Indian Council of Medical Research.

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If the vaccines are cleared by the expert panel, the applications will then move to the regulatory body Drugs Controller General of India (DGCI) for final approval – paving the way for the vaccination process to start by this month.

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Serum Institute of India, incidentally, has already produced around 50 million doses of the Oxford-AstraZeneca jab and plans to scale it upto 100 million by March next year, according to it’s CEO Adar Poonawalla earlier this week. The UK, only recently, had given the green signal for AstraZeneca for human use, the second coronavirus vaccine to be cleared for rollout in Britain after the Pfizer-BioNTech jabs. Pfizer, incidentally, has sought more time to make their case for approval of the Indian authorities.

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‘Covishield,’ like the Pfizer-BioNTech jabs, requires two doses but is believed to be easier to deliver as it does not need extremely low temperatures for storage. Covaxin, meanwhile, showed it was safe and triggered immune responses in an ongoing early-stage trial and is currently part of a late-stage trial.

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Speaking to the media, Dr Randeep Guleria, Director of All India Institute of Medical Sciences (AIIMS) said on Wednesday that India will have the Covid-19 vaccine within days. Terming the approval for the Oxford-AstraZeneca vaccine for use in the UK as a “big step forward,” he said: “This is very good news that AstraZeneca got approval for its vaccine by UK regulatory authorities. They have robust data and in India and the same vaccine is being developed by the Serum Institute of India. This is a big step forward not only for India but many parts of the world.”

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“This vaccine can be stored at two to eight degrees centigrade. Therefore it would be easy to store and transportation. Storage can be done using a simple fridge rather than what is required in the Pfizer vaccine of minus 70 degrees centigrade,” he said.

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Following are the nine vaccine candidates in India:

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1. Covishield (chimpanzee adenovirus platform): manufactured by Serum Institute of India in collaboration with AstraZeneca; Currently in clubbed Phase 2/3 trials. The company has applied for emergency use authorisation.

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2. Covaxin (inactivated virus platform): manufactured by Bharat Biotech in collaboration with ICMR: Currently in Phase 3 trials in India. Applied for emergency use authorisation.

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3. ZY-Cov-D (DNA platform): being developed by Cadila Healthcare (Zydus Cadila) in collaboration with the Department of Biotechnology. Phase 2 trials currently underway.

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4. Russian vaccine Sputnik V (human adenovirus): Gamaleya National Centre Russia developing it in collaboration with Dr Reddy’s Lab in India. Phase 3 trials underway.

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5. NVX-COV-2373 (protein sub-unit platform) by Serum Institute of India in collaboration with Novavax. Phase 3 trial under consideration.

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6. Recombinant protein antigen-based vaccine by Biological E Ltd, Hyderabad in collaboration with MIT USA: Phase 1,2 trials have started.

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7. HGCO 19 (mRNA vaccine similar platform to Moderna and Pfizer in the USA) by Gennova, Pune with Thomas Jefferson University, USA. Phase 1, 2 to start.

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8. Inactivated rabies vector platform (re-purposed vaccine) by Bharat Biotech and Thomas Jefferson University, USA – in pre-clinical advanced stages of trials

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9. Vaccine by Aurobindo Pharma which is also in the initial stages of trials in India.

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