Detail Review on the Covid Vaccines made/ approved by India 2021
Posted On May 13, 2021
India began the administration of COVID-19 vaccines on 16 January 2021. As of 12 May 2021, India has administered 177,214,256 doses overall, including first and second doses of the currently approved vaccines.
Two vaccines received approval for emergency use in India at the onset of the program, including Covishield (a version of the Oxford–AstraZeneca vaccine manufactured by the Serum Institute of India), and Covaxin (developed by Bharat Biotech). In April 2021, Sputnik V was approved as a third vaccine, with deployment expected to begin by late May 2021.
List of COVID-19 vaccines available in India
It is approved by the Indian Government and it is manufactured by Central Drugs Standard Control Organization (CDSCO).
The Oxford–AstraZeneca COVID-19 vaccine, codenamed AZD1222, and sold under the brand names Covishield and Vaxzevria among others, is a viral vector vaccine for the prevention of COVID-19. The Oxford-AstraZeneca vaccine is being manufactured locally by the Serum Institute of India, the world’s largest vaccine manufacturer.
The vaccine is made from a weakened version of a common cold virus (known as an adenovirus) from chimpanzees. It has been modified to look more like coronavirus – although it can’t cause illness. When the vaccine is injected into a patient, it prompts the immune system to start making antibodies and primes it to attack any coronavirus infection. The jab is administered in two doses given between four and 12 weeks apart. It can be safely stored at temperatures of 2C to 8C and can easily be delivered in existing health care settings such as doctors’ surgeries.
The jab developed by Pfizer-BioNTech, which is currently being administered in several countries, must be stored at -70C and can only be moved a limited number of times – a particular challenge in India, where summer temperatures can reach 50C.
An analysis published on 19 February 2021 showed an efficacy of 76.0% at preventing symptomatic COVID-19 beginning at 22 days following the first dose, increasing to 81.3% when the second dose is given 12 weeks or more after the first.
One in four people experiences mild, short-lived systemic side effects after receiving the COVID-19 preventive by Oxford-AstraZeneca (ChAdOx1 nCoV-19) vaccine — known as Covishield in India — with headache, fatigue, and tenderness the most common symptoms, according to a study published in The Lancet Infectious Diseases journal.
The researchers from King’s College London in the U.K. also found that most systemic side effects — meaning side effects excluding where the injection took place — peaked within the first 24 hours following vaccination and usually lasted 1-2 days.
Systemic effects included headache, fatigue, chills and shiver, diarrhea, fever, arthralgia, myalgia, and nausea. Local side effects — meaning side effects where the injection took place in the arm — included pain at the site of injection, swelling, tenderness, redness, itch, warmth, and swollen armpit glands.
The gap between two doses of the Covishield COVID-19 vaccine can be increased to 12-16 weeks, a government panel recommended on Thursday. No changes were suggested in dosage intervals for Covaxin, the second of two vaccines in use in India at this time, which remains at four to six weeks.
COVAXIN®, India‘s indigenous COVID-19 vaccine by Bharat Biotech is developed in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV).
The indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) high containment facility. The vaccine is developed using Whole-Virion Inactivated Vero Cell-derived platform technology. Inactivated vaccines do not replicate and are therefore unlikely to revert and cause pathological effects. They contain dead virus, incapable of infecting people but still able to instruct the immune system to mount a defensive reaction against an infection.
Covaxin, India’s first domestically-developed Covid-19 vaccine, is a two-dose jab that uses an inactivated or “dead” form of the virus. The shot also showed 100% efficacy at preventing severe Covid-19 and hospitalisations, according to a joint statement from Bharat and co-developers, the Indian Council of Medical Research (ICMR).
Side effects that have been reported with the Bharat Biotech COVID-19 (COVAXIN ) include:
Injection site pain / Swelling / Redness / Itching
A severe allergic reaction may very rarely occur after getting a dose of COVAXIN.
These may not be all the possible side effects of COVAXIN. Serious and unexpected side effects may occur. COVAXIN is still being studied in clinical trials.
Sputnik V is a viral vector vaccine for COVID-19 developed by the Gamaleya Research Institute of Epidemiology and Microbiology. Registered on 11 August 2020 by the Russian Ministry of Health as Gam-COVID-Vac. Sputnik V is an adenovirus viral vector vaccine. The V in its name however stands for the alphabet ‘V (for the vaccine), and not the Roman numeral.
Gam-COVID-Vac was initially approved for distribution in Russia and then in 59 other countries (state as of April 2021) on the preliminary results of Phase I–II studies eventually published on 4 September 2020. Approval in early August of Gam-COVID-Vac was met with media criticism in mass media and discussions in the scientific community as to whether approval was justified in the absence of robust scientific research confirming safety and efficacy.
On 2 February 2021, an interim analysis from the trial was published in The Lancet, indicating 91.6% efficacy without unusual side effects . This means the vaccine has the ability to bring down symptomatic Covid-19 cases by nearly 92 percent in those vaccinated compared with those who have not received a Covid vaccine.
For now, the vaccine will be available in India in liquid form, which means DRL will tie up with hospitals that have the ability to store it at minus 18°C. The company is also in the process of seeking approval for a freeze-dried form of the vaccine, which will require storage at only 2°C to 8°C.
The vaccine will be available for customers by mid-June, when commercial shipments are expected to begin, DRL said. The company, which has an agreement with its Russian partner to acquire 250 million doses of Sputnik V, expects to be able to vaccinate at least 125 million Indians over the next 8-12 months.
Around 15-20 per cent — or up to 50 million of these doses — are expected to be supplied from Russia, while the company waits for local production of the vaccine to pick up.
DRL is also in discussions with the partner, the Russian Direct Investment Fund (RDIF), on receiving approvals for “Sputnik Light”, a single-dose version of the vaccine.
This is SII’s version of NVX-CoV2373, the protein-based Covid-19 vaccine developed by Novavax, headquartered in USA. In August 2020, the two companies announced an agreement under which Novavax had given SII the licence to manufacture and supply the vaccine in low- and middle-income countries as well as India. The agreement is expected to support the supply of a minimum of 1 billion doses of this vaccine in these regions.
How does Covovax work?
Like several other Covid-19 vaccines, Covovax targets the spike protein on the surface of the SARS-CoV-2 coronavirus — the protein that allows the virus to penetrate the human cell. Novavax has achieved this is by engineering copies of the spike protein in the lab using the cells of a moth.
Modified spike genes are placed in a baculovirus, which is known to infect insects. This virus is then used to infect the moth cells, carrying the spike gene into the cell. The cells then create the spike proteins, which are harvested. After they are purified, a certain dosage of these spike proteins are used as the vaccine.
Once a person is given a shot of this vaccine, their body is expected to recognise these copies of the spike proteins as a foreign substance and build immunity against them. When the real virus tries to infect the cell, the body is expected to be able to fight it off.
What is the efficacy of Covovax?
The vaccine recently showed an efficacy of 96.4% against mild to severe disease caused by the original strain of SARS-CoV-2 from ongoing late-stage global trials. It has also managed an efficacy of around 83.4% two weeks after the first dose — potentially promising finding at a time when vaccine makers might face hurdles in scaling up supplies.
Against mutant variants of the virus, it showed an efficacy of around 86.3% (UK variant) and only 55.4% among HIV-negative participants in its trial in South Africa.
Compared with this, Covishield (SII’s other Covid-19 vaccine) has an efficacy around 53% when the second dose is given less than six weeks after the first dose, which is the regimen followed in India. The efficacy of the AstraZeneca-Oxford vaccine, which Covishield is based on, varies based on the duration between the first and second shots and can go to nearly 79% if the gap is 12 weeks or longer.
ZyCoV-D is a DNA plasmid-based COVID-19 vaccine being developed by Cadila Healthcare with support from the Biotechnology Industry Research Assistance Council.
Phase I and II trials
In February 2020, Cadila Healthcare decided to develop a DNA plasmid based COVID-19 vaccine at their Vaccine Technology Centre (VTC) in Ahmedabad. The vaccine candidate was able to pass the pre-clinical trials on animal models successfully. A report of the study was made available via bioRxiv. Thereafter, human trials for Phase I and II were approved by the regulator.
The Phase II trials of the vaccine candidate were conducted in over 1,000 volunteers as part of the adaptive Phase I/II multi-centric, dose escalation, randomised, double-blind placebo controlled method.
Phase III trials
In November 2020, the company announced it would test the vaccine candidate on 30,000 patients in Phase III trials. The vaccine would be given out in three doses at five sites across four cities of India. In January 2021, the Drugs Controller General of India (DCGI) granted permission to conduct the Phase III clinical trials for 28,216 Indian participants.
In April 2021, the company reported that they expected to have initial data for the Phase III trials by May 2021.
On 23 April 2021, production of the ZyCoV-D vaccine was started, with a yearly capacity of 240 million doses. It is expected to get emergency use authorization in May or June.