ANALYSIS COVID VACCINE
KS Shankar / IHN-NN
NEW DELHI: India this week crossed a major milestone in the fight against the Chinese-induced Covid-19 pandemic as it released a detailed guideline for start of the vaccination process that will last some six or more months. The aim is to vaccinate the entire population in stages, starting with health workers and those above age 50 first.
Hopes for an early end to the pandemic’s spread are soaring. There already is a downward trend in the daily Covid tally and the recovery rate has reached impressive levels. The vaccines developed by major pharma firms are getting ready for regulatory approvals, roll-out and distribution. The New Year will see India beginning distribution of vaccines while a similar exercise has already started in the worst-hit United States. Vaccines are ready for use in Europe and the rest of the affected regions as well. Notably, China has come up with its own vaccine to rein in the virus it spread around the world, and this will be distributed to other countries too.
India on Monday released detailed guidelines for distribution, storage and administration of the vaccine to select groups first and the general public next. By the middle of 2021, the scenario would return to near-normal, say health specialists tracking the virus’ course.
Companies manufacturing the vaccine have entered the final phase of the production and are seeking approvals from the central drugs regulators. They expect to get this on an emergency basis later this month itself from the Drug Controller General in India (DCGI) and scientists. Thereafter, the mammoth exercise to inculcate the first group of 30 crore citizens will start.
India, the world’s largest vaccine-maker, is expected to roll-out its first vaccines in the next few weeks with at least three candidates under active consideration of the drug controller.Pune-based Serum Institute of India and Hyderabad-based pharmaceutical firm Bharat Biotech have already applied to DCGI seeking emergency authorization for their Covid-19 vaccines. No significant health hazard is likely from the jabs.
Notably, the Bharat Biotech International Ltd, the Biological E Ltd, the Cadila Healthcare Ltd, the Serum Institute of India Pvt Ltd (SII) , Dr Reddy’s Laboratories and Wockhardt are involved in the Covid vaccine development and manufacturing. Of them, two have applied for Emergency Use Authorization (EUA), the Union Health Ministry has stated.
Pfizer was the first company to apply for distribution of vaccine in India for emergency use authorization of the vaccine developed by it and BioNTech. Apart from Pfizer’s application, the Subject Expert Committee (SEC) meeting in India also looked at Bharat Biotech’s application for its Covaxin, based on data from Phase 1/2 trials and Serum Institute of India’s application for Covishield, based on Phase 3 trial data conducted outside India, and the Phase 1/2 trials data conducted in India.
Researchers and drug-makers have been working tirelessly for months to find an effective and safe jab against the virus. While the whole world has been trying to find ways to tackle the pandemic, India has emerged as one of the important countries in the race for vaccine development. Indian pharmaceutical sector enjoyed a high global reputation in recent years. Three of the most-popular vaccines that are being tested and developed in the country include – Serum Institute of India’s Covishield, Bharat Biotech’s Covaxin, and Zydus Cadila’s ZyCoV-D.
Prime Minister Narendra Modi has visited three cities on November 29 to conduct an extensive review of the vaccine development, touching down at the Zydus Biotech Park in Ahmedabad, the Bharat Biotech in Hyderabad and the Serum Institute of India in Pune. The first two are proceeding with developing their own vaccines, while Dr Reddy’s has tied up with Russia to conduct trials of its Sputnik vaccine.
SERUM INSTITUTE LEADS THE WAY
The Covidshield vaccine is being developed jointly by Oxford University, AstraZeneca and the Serum Institute of India (SII), which is the world’s largest vaccine manufacturer. Currently, the SII is producing around 50-60million doses, and the manufacture would be scaled up to to 100million by January 2021, SII CEO Adar Poonawalla said. He added: “Covishield should be ready by the end of this month.” SII has already produced about 40 million doses of the vaccine and Indians will get priority when it comes to meeting the current demand.
Bharat Biotech, along with the Indian Council of Medical Research is developing India’s first home-grown vaccine. Known by the name Covaxin, the vaccine candidate is currently going through phase 3 trials at several locations, including AIIMS Delhi. According to recent reports, the company said that they aim at least 60 per cent efficacy for the vaccine, after which it is expected to be rolled out mid of 2021. Bharat Biotech will manufacture the Covid-19 vaccine Covaxin, in Odisha, along with nine other vaccines.
Zydus Cadila’s vaccine is currently under phase 2 of human trials. The vaccine is expected to be ready by March 2021. In July, the firm had said that they aim to complete human trials of the vaccine within seven months. Russia’s much-talked-about Sputnik V is undergoing trials at Dr Reddy’s Laboratories in Hyderabad. The vaccine showed 95 per cent efficacy in trials so far. NVX-CoV2373 is being developed by Serum Institute of India in collaboration with Novavax and its phase-three trials are under consideration of the drug regulator.
HEALTH MINISTRY GUIDELINES
Meanwhile, the Union Ministry of Health has sent its operational guidelines to states and Union territories for distribution of the vaccines as and when they are ready. The document shared with all states says that only 100 people per “session” at each site per day are likely to be vaccinated against Covid-19. However, the number of people per “session” might go up to 200 if logistics allowed. “If in any case, more than 200 people are being vaccinated within a session, then a whole team of 5 people will have to be deployed separately (one vaccine officer and four vaccination officers),” the SOP read.
The government, in a document that explores how best to deploy the vaccine whenever it is available, says that the states and Union Territories can fix the days for the vaccination. “Conduct of the vaccination process [will be] similar to the election process.” As per the government’s new SOP on Covid-19, a vaccination site should have three rooms or areas including a waiting room, a vaccination room and an observation room.
The vaccine will be first given to health care workers (1crore), frontline workers (2crore), and people above 50 years (26 crore). After this, vaccines will be given to those below 50 years of age who are suffering from a chronic critical illness (1 crore). Thus, a total of 30 crore people will be vaccinated in phase-1), as per the health ministry’s plan.”One session for 100 beneficiaries. While most of the healthcare and frontline workers would be vaccinated at fixed session sites, vaccination of other high-risk populations may require outreach session sites, and mobile sites and teams,” it said.
Based on the voters’ lists, people above age 50 will be identified and vaccinated in the first phase. After this, the rest of the population will be given the Covid-19 vaccine, whenever it is ready for public use, based on the spread and availability of this disease. “The beneficiaries will be tracked through a digital platform called Co-WIN. All information on this platform will be updated in real-time,” the draft SOP stated.
Union Health Minister Harsh Vardhan earlier said that the country will look to vaccinate 250 to 300 million people against coronavirus in the first phase on priority by July next year.
STATES GET SET
States have started preparing for vaccinating the people in phases as advised by the Union Health Ministry. Haryana health minister Anil Vij said that the state government had written to the Centre to have public representatives including MLAs and MPs listed among the priority groups for vaccination once the vacination begins. He added that the government was making all preparations such as building a database of priority groups, cold chain infrastructure and training of vaccinators for rolling out the Covid-19 vaccine.
Kerala’s Chief Minister Pinarayi Vijayan has announced that vaccines to combat the coronavirus disease will be given free of cost to the state’s population adding that the government will take care of all expenses. Vijayan also pointed out that vaccines would be first administered to the frontline health workers.
The Telangana government has formed committees at the state, district and mandal levels for planning and executing the distribution with first priority to high risk groups followed by other people. According to a government order, the committees would also undertake a structured review of all factors related to the preparedness and implementation of vaccines.
The BJP-led government in Uttar Pradesh has started training vaccinators for injected vaccine doses before the vaccine is available. Two batches from the state had participated in an online session ‘training-of-trainers’, which was conducted by the Union health ministry. The state will have 35,000 vaccination centres and vaccinators will record the data of people who are administered doses on an online platform.
While the Chandigarh administration is already identifying health care workers for vaccination, residents willing to receive doses will have to register in advance on the CoWin-20 mobile app. The health department of the Union Territory would be giving doses to healthcare workers first, followed by people over 50 years of age and those having comorbidities.
Being one of the worst-hit states, Maharashtra is preparing to vaccinate over 30 million residents over three phases in six months. The first phase will be focused on administering doses to health care workers. Frontline workers would be vaccinated in the second phase while people above the age of 50 and having comorbidities will be given vaccine shots in the third and final phase.
The preparations are being undertaken on a war-footing in Uttarakhand. The vaccination will start as soon as vaccines are made available by the Centre, said state health minister Amit Negi. The Drone Application and Research Centre (DARC) under the Information Technology Development Agency (ITDA) is setting up its devices to supply the vaccine in the remote areas of the hill state.
VACCINATION IN CAPITAL DELHI
Delhi state government has ramped up its preparedness to vaccinate residents. The government has identified cold chain storage points, beyond training thousands of healthcare staff on technical details. Around 609 cold chain points have been identified in Delhi. Cold chain points will be present from major hospitals such as Rajiv Gandhi Super Specialty Hospital, Loknayak Hospital, Kasturba Hospital, Babasaheb Ambedkar Hospital, GTB Hospital to Urban Public Health Center and Mohalla Clinics.
Dr Sunila Garg of Maulana Azad medical College, who has been appointed as the public health expert under the vaccination programme in Delhi, said that the training of all senior officers associated with the immunisation has been done by the central government. Around 3500 health workers have been identified in Delhi to carry out the vaccination process. Out of these, 1800 employees will be stationed at cold chain points. Health workers will be deployed at every cold storage facility. Out of the 3500 healthcare workers, around 600 are from the private sector.
A total of 600 medical officers in Delhi will be trained to monitor the cold chain points across the national capital. The identified cold storage facilities are equipped with deep freezers, refrigerators, walking coolers, vaccine carriers, and thermocol carriers for the storage of the vaccine vials.
Punjab has geared up for the mega exercise with a total of 729 cold chain points. Besides one state-level vaccine store, 22 district vaccine stores and 127 block level vaccine stories are being prepared for the roll-out of the vaccine in Punjab, which will also have 570 cold chain points. Besides one walk-in freezer at Ferozepur, the Union Government has decided to provide one more at Chandigarh. In addition, the state will have one walk-in cooler each at Amritsar, Hoshiarpur and Ferozepur, with more to be received from the Centre. In addition, the state has 1165 Ice Lined Refrigerators and 1079 Deep Freezers.
The Srinagar district administration has prepared a micro plan for Covid-19 vaccination under which the entire population of the district will be vaccinated within four months. The Covid-19 vaccine, when it is available, will be collected and stored at 50 cold chain points or CCPs located in areas spread across Srinagar, the spokesperson said. From CCPs, the Covid-19 vaccine will be transported in vaccine carriers to 123 sites identified as points of inoculation where vaccination will be administered to people as per a separate plan based on a database of prioritized groups of beneficiaries being compiled.
The Bihar government is making preparations for the storage of 2.25 crore doses of the Covid vaccine in the first phase. The state health department is working in tandem with the animal husbandry department for the storage of the Covid vaccines. Bihar presently has 674 cold storage points across the state where 1.37 crore Covid-19 vaccines doses can be stored. Preparations are being made to create additional infrastructure to store another 1 crore doses. In Patna alone, the local administration has ramped up infrastructure to store 10 lakh doses of the Covid-19 vaccine.
In Gujarat, the cold chain infrastructure needed for the storage and transport of vaccines has been set up It has also organised and prepped the teams of vaccinators. There will be 27,796 vaccination centres and 15,534 teams for vaccinations. The Centre is also gearing up with 28,947 cold chain points with 85,643 pieces of equipment across the country that are capable of storing the vaccines needed for the first set of three crore health and frontline workers.
The Centre is mobilising additional vaccinators, a digital platform for vaccine delivery and a detailed implementation plan to inoculate around 30 crore priority population in the first phase expected to get underway soon.
Who will be on vaccine priority list? Healthcare Workers (govt and private): 1 crore; frontline workers (personnel from state and central police department, armed forces, home guards, civil defence organisations including disaster management volunteers and municipal workers: 2 crore. Prioritised age groups: 27 crore (those above the age of 50 years and less than 50 years with comorbidities.
STATE-LEVEL STEERING COMMITTEES
Under the umbrella of the National Expert Group on Vaccine Administration for Covid-19 (NEGVAC), vaccine distribution will be led by states with the help of state-level steering committee. The state committee will be led by the 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. States will also have a state 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. A district control room will also be set up. Of the total number of vaccinators in India under the UIP which is 2.39 lakh vaccinators, NEGVAC estimates to deploy 1.54 lakh auxiliary nurse midwives (ANMs) for Covid-19 vaccination.
Airports across the country are bracing themselves to handle what will possibly be the largest and most critical vaccine distribution programme in recent history. The Delhi International Airport has two cargo terminals with world-class infrastructure that includes a GDP (Good Distribution Practice) certified temperature-controlled facility for handling temperature-sensitive cargo. GMR Hyderabad Air Cargo (GHAC) is also a key stakeholder in the transportation of the Covid-19 vaccine. The airport is equipped with facilities such as modern temperature-sensitive pharma and vaccine storage and processing zones. It also has India’s largest storage facility for various kinds of air cool containers such as envirotainer, c-safe, unicooler, and vaqtainer within the premises. GHAC is also upgrading its infrastructure to double the capacity on both landside and airside to handle the upcoming surge in volumes.
Mumbai’s Chhatrapati Shivaji Maharaj International Airport (CSMIA) has Asia’s largest temperature-controlled Export Pharma Excellence Centre with an annual handling capacity of 350,000 tons, spread over an area of 4,000 square meters. CSMIA also plans to create a dedicated task force to facilitate vaccine transportation. This team will undertake advance planning and collaborate with all stakeholders such as other airports, airline customers, supply chain partners, regulatory and governmental bodies, and vaccine distributors.
At present, the cargo facility at Pune airport has the capacity to handle 1.5 tonne of cargo on a daily basis. But the airport at Pune is planning to upgrade for smooth and efficient distribution of the Covid-19 vaccine. The airport authorities are also in touch with the city’s Serum Institute of India and other stakeholders to plan a change in the existing infrastructure. –IHN=NN
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