The new year has brought with it some reason for cheer. In what is set to be amongst the largest vaccination drives in the world, India is gearing up to begin vaccinating its population against the novel coronavirus from January 16. The development is especially critical at a time when close to a 100 people have been infected by the mutant strain of the Covid-19 virus which originated late last month in the UK and is known to be more infectious than the original strain.
The Central Drugs Standards Control Organization has approved two vaccines – Covishield and the indigenously-developed Covaxin – for restricted emergency use in the country. The approval was given by the drug regulator on January 3 and the Union Health Ministry has stated that the government is prepared to roll out the vaccine in a phased manner starting January 16.
Covaxinhas been developed by Hyderabad-based Bharat Biotech in collaboration with the Indian Council for Medical Research (ICMR) and the National Institute of Virology.Covishield is developed by the University of Oxford and British-Swedish pharmaceutical company AstraZeneca. Its India partner is Pune-based Serum Institute.
The government aims to vaccinate 30 crore people by mid 2021 defining them as “priority population”. They include frontline health workers, essential duty personnel and vulnerable sections of population.
The Approval Process
The Subject Expert Committee of the Central Drugs Standard Control Organisation met on 1st and 2nd January, 2021 and made recommendations in respect of the proposal for restricted emergency approval of Covid-19 virus vaccines ofthe Serum Institute of India and Bharat Biotech as well as for conducting the Phase three clinical trial of ZydusCadilaHealthcare.
Serum Institute of India, Pune presented results from Covishield, a recombinant chimpanzee adenovirus vector vaccine encoding the SARS-CoV-2 spike glycoprotein with technology transfer from AstraZeneca/Oxford University. The firm submitted safety, immunogenicity and efficacy data generated on 23,000 plus participantsfrom overseas clinical studies. The overall vaccine efficacy was found to be 70.42%. The firm also submitted the interim safety and immunogenicity data generated from phase three ofclinical trials in India involving 1600 participants.The data was found comparable with the data from the overseas clinical studies. After detailed deliberations the Subject Expert Committee recommended the grant of permission for restricted use in emergency situation subject to certain regulatory conditions. The clinical trial ongoing within the country by the firm will continue.
Bharat Biotech, Hyderabad has developed a whole virion inactivated corona virus vaccine called Covaxinin collaboration with ICMR and NIV (Pune), from where they received the virus seed strains. This vaccine is developed on the Vero cell platform, which has a well established track record of safety and efficacy in the country and globally.The firm has generated safety and immunogenicity data in various animal species such as mice, rats, rabbits, Syrian hamster, and also conducted challenge studies on non-human primates (rhesus macaques) and hamsters. All related data was shared by the firm with the CDSCO. Phase one and two of its clinical trials were conducted in approximately 800 subjects and the results have demonstrated that the vaccine is safe and provides a robust immune response. The phase three efficacy trial was initiated in India in 25,800 volunteers and till date over 22,000 participants have been vaccinated across the country and the vaccine has been found to be safe as per the data available till date.It is also believed, based on the company’s filings, that because Covaxin uses the “whole inactivated virion,” it would have the potential to target mutant coronavirus strains, the kind that has been detected in the UK.
The Subject Expert Committee reviewed the data on safety and immunogenicity of both the vaccines and recommended the grant of permission for restricted use in public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains.
The successful introduction of the COVID-19 vaccine will largely depend upon, not just logistical arrangements, but also the quality of training conducted for enumerators for beneficiary listing, health functionaries for vaccination activities, social mobilizers for mobilization activities, and communication training for all workers involved in the process of vaccination.
The COVID-19 Vaccine Intelligence Network (Co-WIN) system, a digital platform is being developed track the enlisted beneficiaries for vaccination and COVID-19 vaccines on a real-time basis. The Co-WIN software will provide real-time information of vaccine stocks, their storage temperature, and individualised tracking of beneficiaries for the vaccine. This software will assist the programme managers across all levels through automated session allocation for pre-registered beneficiaries, their verification, and a digital certificate will be generated upon successful completion of the vaccine schedule.
Two pan India dry runs were conductedacross the country’s 700 plus districts to understand practical challenges and plug loopholes in logistics and training. The first massive dry run was held on January 2. The day-long exercise tested the operational feasibility of the CoWIN application in a field environment. The second dry run was conducted on January 8, Friday. Around 1.7 lakh vaccinators and 3 lakh vaccination team members were trained on the process to be followed at the vaccination sites which include beneficiary verification, vaccination, cold chain and logistics management, bio-medical waste management, AEFI (adverse events following immunization) management and reporting on theCoWINapp.
Children and pregnant women are routinely vaccinated under its universal immunization program. Using the same platform to store vaccines at 2 to 8 degrees centigrade, it will be easier for the government to store and administer the COVID-19 vaccines.
Who will get it first?
According to the recommendations of the National Expert Group on Vaccine Administration for Covid-19, India’s healthcare workers that is doctors, nurses, medical officers, paramedics, and other support staff including medical students will get vaccinated under the first phase. The government has identified 3 crore beneficiaries under this phase and aims to vaccinate them by March.
Next in line will be frontline personnel engaged in Covid-19 containment activities. These include central and state police departments, armed forces personnel, civil defence and prison staff, disaster management forces, home guard, municipal workers and revenue services personnel, personnel from state ministries of home, housing, and urban affairs.
The third phase will cover population above 50 years of age and those with comorbidities. This category is further divided into those above 60 and those between 50 to 60. Once the above priority population is vaccinated, the remaining population will be vaccinated in a phased manner
Registering for the vaccine
The latest electoral roll for Lok Sabha and assembly elections will be used to identify senior citizens. The remaining population will have to self-registeron the Co-Win app. Registration will include uploading government photo id and a date and time will be allocated to the individual. A five member vaccination team will overlook the process.
There will be fixed venues at hospitals and medical centres for different priority groups, besides outreach sites in schools and community halls. Special mobile teams for remote areas will also be planned by respective district administrations.
At the vaccination site, only pre-registered beneficiaries will be vaccinated per the prioritization, and there will be no provision for on-the-spot registrations.
The vaccination process
Two doses of the vaccine, 28 days apart, need to be taken by the individual to complete the vaccination schedule. Protective levels of antibodies are supposed to develop a fortnight after the second dose.
The COVID-19 vaccination will be voluntary, the health ministry earlier stated. However it is advisable “to receive the complete schedule of the vaccine for protecting one-self against this disease and also to limit the spread of this disease to the close contacts including family members, friends, relatives and co-workers,” the ministry said.
Transportation and Storage
Pune in Maharashtra, where the Serum Institute of India is located, will be the central hub from where vaccine distribution will happen. The Central Government has allowed passenger aircraft to transport the Covid-19 vaccines.
As many as 41 destinations across India have been finalised for the delivery of Covid-19 vaccines.The national capital and Karnal will be made mini hubs for delivery of coronavirus vaccines in northern India. For the eastern region, Kolkata will be the hub and will also be a nodal point for the northeast.Chennai and Hyderabad will be the designated points for Southern India.
The Airports Authority of India will deploy its resources to facilitate the transportation of COVID-19 vaccine across the country from Pune in Maharashtra. Consignments of Covishield are scheduled to be dispatched to various locations in the country from the Pune airport.
The health ministry has informed that existing logistics management and real-time remote temperature monitoring has been implemented across 29,000 cold chain points as part of the the CO-WIN vaccine delivery management system. The health ministry’s Secretary Rajesh Bhushan had said earlier last month that 29000 cold chain points, 240 walk-in coolers, 70 walk-in freezers, 45000 ice-lined refrigerators, 41000 deep freezers and 300 solar refrigerators will be used for the Covid-19 vaccine storage
Covishield vs Covaxin
Covishield vaccine has been developed by using the virus — adenovirus — that causes common cold infections among chimpanzees. Its genetic material is same as that of the spike protein of SARS-CoV-2 coronavirus. Spike protein is the part of SARS-CoV-2 using which the virus enters a human body cell. Covishield vaccine has been developed by using a weakened version of the adenovirus.
Covaxin vaccine has been developed using dead coronavirus — called “inactivated” vaccine in medical language. Under inactivated state, the virus is not capable of infecting people or replicating on its own inside the body of a person after being injected. But a shot of the vaccine prepares the immunity system to recognise the actual virus and fight it if and when infection happens.
While Covaxin is still in the final stage of clinical trial and no efficacy rate has been made public for this Covid-19 vaccine, the efficiency of Covishield has been pegged at over 70 per cent. This efficacy rate is far below than the vaccines developed by Pfizer-NBiotech and Moderna, but it is above the qualifying efficacy benchmark of 50 per cent set by several countries.
Other Covid Vaccine Candidates in India
Apart from Covishield and Covaxin, there are multiple candidates in India, all in different stages of the clinical trial process. Zydus Cadila’s vaccine ZyCoV-D has been given approval for Phase 3 trials.Russian vaccine Sputnik V is also a contender. Dr Reddy’s Laboratories is conducting phases 2 and 3 clinical trials of the vaccine. Serum Institute will also conduct the trials for Novavax’s vaccine candidate in India as well as manufacture it. Biological E Limited, and Gennova Biopharmaceuticals have a candidate each. Bharat Biotech is working on another vaccine with Thomas Jefferson University. Aurobindo Pharma Ltd has also announced its own COVID-19 vaccine development programme.