Introduction: COVID Vaccine in India
There are several institutions including academic/research and vaccine manufacturing companies in India that are in the process of developing of Covid-19 vaccine. There are four companies listed on the WHO website that are in the process of various stages of development. Serum Institute of India, in collaboration with Oxford University and Astra Zeneca, is undertaking a Phase 3 trial of the ChAdOx1 nCoV-19 vaccine in approximately 1600 healthy subjects 18–55 y of age. On successful completion of the Phase 3 trial with one dose of vaccine, the company shall start mass production.
Current Major Players in India for COVID-19 Vaccine
COVAXIN™ is India’s original COVID-19 vaccine developed by Bharat Biotech in cooperation with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV) – Government of India. This native form of the vaccine is developed and manufactured at Bharat Biotech’s high containment facility having the maximum bio-safety level (BSL-3).
The vaccine received approval from the concerned regulatory authorities for conducting human clinical trials to check its safety and effectiveness in healthy subjects. After successful completion of the interim analysis from the Phase 1 & 2 clinical trials of COVAXIN™, Bharat Biotech also received approval for Phase 3 clinical trials in 26,000 participants in over 25 centers across India.
Present Status of COVAXIN™ Vaccine Trial in India
- Pre-clinical studies with small and large animals: COMPLETED.
- DCGI approval for Phase I & Phase II Human Clinical Trials: RECEIVED.
- Phase I Human Clinical Trial: COMPLETED.
- Phase II Human Clinical Trial: COMPLETED.
- DCGI approval for Phase III Human Clinical Trials: RECEIVED.
- Phase III Human Clinical Trial: ONGOING.
The Serum Institute of India (SII) and Indian Council of Medical Research are jointly conducting advanced phases of clinical trials to determine the safety and the ability of Covishield (COVID-19 Vaccine) to induce an immune response.
ICMR has funded the clinical trial site fees while SII has funded other expenses for COVISHIELD. At present, SII and ICMR are conducting Phase 2/3 clinical trial of the vaccine at 15 different centers, across the country. It has completed the enrolment of all 1600 participants, as of 31 Oct 2020. The vaccine is being developed at the SII Pune laboratory with a master seed obtained from Oxford University/Astra Zeneca. The original vaccine prepared in the UK is currently being tested in large effectiveness trials involving participants from the UK, Brazil, South Africa and the USA. The encouraging outcomes from these trials so far have boosted assurance that COVISHIELD could be a genuine way out from this fatal pandemic. COVISHIELD is by far, in the most advanced phase of vaccine testing in Indians. SII along with ICMR will track the first disposal of this vaccine for the Indian population based on the Phase 2/3 trial results. SII has already mass-produced > 40 million doses of the vaccine, under a license from DCGI.
Indian pharmaceutical giant, Zydus Cadila, involved in manufacturing innovative medicinal products, has declared its vaccine, ZyCoV-D for prevention of COVID-19 infection. The safety of this vaccine in healthy individuals is established in its Phase I clinical trial and has been recognized by an Independent Data Safety Monitoring Board (DSMB). On this basis, Zydus commenced the Phase II trial of its vaccine.
Present Status of ZyCoV-D Vaccine Trial in India
- DCGI approval for Human Clinical Trials: RECEIVED
- Phase I Human Clinical Trial: COMPLETED
- Phase II Human Clinical Trial: ONGOING
Dr. Reddy’s Laboratories Limited and Sputnik LLC are together carrying out a multicentre, phase II/III adaptive clinical trial to evaluate the safety and ability of its vaccine to invoke an immune response.
Present Status of Sputnik Vaccine Trial in India
- DCGI approval for conducting Human Clinical Trials: RECEIVED
- Phase II Human Clinical Trial: ONGOING.
5) Biological E’s novel Covid-19 vaccine
Biological E Limited is piloting an initial phase of a clinical trial to assess the safety and capacity of its novel Covid-19 vaccine to induce an immune reaction against SARS-CoV-2 for preventing Covid-19 disease, upon intramuscular administration in two doses (0, 28D) to healthy volunteers. (Information based on ICMR website)
Present Status of Biological E Vaccine Trial in India
- DCGI approval for Phase I & Phase II Human Clinical Trials: RECEIVED
- Phase I/II Human Clinical Trial: ONGOING
Government Plan to roll out COVID-19 vaccine in India
The Indian government is getting prepared to roll out its Covid-19 vaccination drive through state-of-the-art technologies and alphanumeric trackers while depending on the established methods of distribution of vaccines. The strategic planning of vaccine roll out and its distribution throughout the country is being done by the National Expert Group on Vaccine Administration, a member at the NITI Aayog.
1) Criteria For Identifying Who Gets Vaccinated First:
As per government authorities, a full study on the urgency segments of the population that would have the first right of entry to the vaccination has been prepared based on recommendations of CDC (USA) and the WHO. Regardless of their financial background, the vaccine will be initially offered to individuals who are in urgent need.
2) Priority Groups Identified For The First Phase Of Covid-19 Vaccination:
The first allotment of 3 crore people to be vaccinated has been recognized. These include approximately 1 crore doctors and 2 crore health care personnel, including policemen, home guards, defense officers, civic workers including Asha workers and community workers.
People aged > 50 years and those aged < 50 years but having co-morbidities will be vaccinated in the second round.
The government strategizes to use the novel eVIN (Electronic Vaccine Intelligence Network) platform for storage and tracking of the vaccine and the citizen digital health ID to guarantee immunization while counting on the identical route of the Universal Immunisation Program (UIP).
3) Vaccine Stocking:
The authorities have confirmed that the eVIN network, is being re-equipped for delivering the COVID vaccine. The eVIN platform is currently functional across twelve states in India. It aims to help the Indian Government’s Universal Immunization Programme by providing actual information on available vaccine stocks and their transportation, as well as storage temperatures across all cold chain logistical hubs in these locations.
Approximately, 17,000 government officials have been skilled on the eVIN application while more than 6,700 temperature loggers have been functionalized. The program is to be ascended to cover the entire nook and corner of the country.
4) Vaccine Distribution:
The vaccine distribution will be as per the voter registration application to ensure each citizen is covered.
5) Role of State Governments
The Central government has notified the State governments to form committees for the Covid-19 vaccine roll-out. The state’s role will be to vaccinator identification through government and private sectors to restrict disturbances in repetitive immunization services at the time of Covid-19 vaccine introduction, and planning and charting sessions of vaccination for health care personnel. Mostly, the Covid-19 vaccination drive will last over a year with many groups being vaccinated serially beginning from health care workers. Hence, a strong guidance and coordination mechanism is vital to be created at the state and district level to monitor the process of Covid-19 vaccination with the assurance of minimum disturbance to other regular healthcare services.
As of today, the vaccine will take some time for the actual rollout but transport provisions will have to be kept ready well in advance to prevent any last-minute problems.