Ahmedabad-based pharmaceutical firm Zydus Cadila has received a nod for Emergency Use Authorization (EUA) from the Drug Controller General of India (DCGI) for ZyCov-D, its Covid-19 vaccine on 20th August 2021. ZyCov-D becomes the world’s first and India’s indigenously developed DNA vaccine against infection from SARS-CoV-2. ZyCov-D becomes the second indigenous coronavirus vaccine after Covaxin and the sixth vaccine to get Emergency Use Approval in India by the government. The other vaccines include Bharat Biotech’s Covaxin, Serum Institute of India’s Covishield, SputnikV by Gamaleya Research Institute and US-made Moderna and Johnson & Johnson.
On this remarkable feat, Prime Minister Narendra Modi lauded the Indian scientists for coming up with the world’s first DNA based vaccine.
India is fighting COVID-19 with full vigour. The approval for world’s first DNA based ‘ZyCov-D’ vaccine of @ZydusUniverse is a testimony to the innovative zeal of India’s scientists. A momentous feat indeed. https://t.co/kD3t7c3Waz
— Narendra Modi (@narendramodi) August 20, 2021
Know about your vaccine: What is it & How does it work?
ZyCov-D, which is ready to be administered in adults and children above 12 years of age, is developed in partnership with the Department of Biotechnology, Government of India, under the ‘Mission COVID Suraksha.’ ZyCov-D is a needle-free vaccine that will be administered using ‘Jet Injector’, a technique where the needle piercing the skin is substituted by the liquid injecting directly through the upper layer of the skin, which gets penetrated into the underlying tissues. This technique has been in use for more than a century, as the first jet injector was administered in the year 1866.
The three-dose vaccine is a ‘plasmid DNA’ vaccine. Plasmid implies a genetic structure in a cell that is non-replicating or replicating independently of the chromosomes. In this vaccine, the plasmids play a crucial role as they are coded with the instructions to make the spike protein of the SARS-CoV-2, the virus responsible for causing Covid-19. Now, when the recipient receives the vaccine, it contains the code that reaches the cell in the person’s body and it starts making the spiky outer layer of the virus. The recipient’s immune system is expected to recognize this as a threat and in turn, have to develop antibodies in response.
It is interesting to note that, while most Covid-19 vaccines are given in two doses, or some even in a couple of single-shot, ZyCov-D will be administered in three doses, with an interval of 28 days between the first, second and third shots.
Safety & Efficacy of the Vaccine:
After evaluation of interim Phase III clinical trial results in consultation with Subject Expert Committee, CDSCO has approved DNA COVID-19 vaccine (ZyCoV-D) of M/s Cadila Healthcare for restricted use in emergency situation in India for 12 years and above.
— CDSCO_INDIA_INFO (@CDSCO_INDIA_INF) August 20, 2021
The company conducted the largest clinical trial for its COVID-19 vaccine in India so far in over 50 centres. This was also the first time that any COVID-19 vaccine has been tested in the adolescent population in the 12-18 years age group in India.
The drugmaker, listed as Cadila Healthcare Ltd, has tested its Covid-19 vaccine ZyCov-D in phase 1, 2 and 3 clinical trials, involving over 28,000 volunteers. Among these, a thousand participants were between the ages of 12 and 18 years. In December 2020, a statement was issued by the Zydus Group Chairman claiming that the first two phases of the trial indicated that the vaccine was ‘safe and immunogenic’. As of now, the primary efficacy of 66.6% has been achieved for symptomatic RT-PCR positive cases from the interim results of Phase III Clinical Trials. This data is based on 79 to 90 RT-PCR confirmed positive cases of those vaccinated in the phase 3 trials. Further, the data suggests that two doses of the vaccine prove enough to prevent people from developing severe symptoms against the virus as well as to prevent death, while the third dose will keep the moderate symptoms at bay.
A cure against Delta Variant:
The company conducted the largest clinical trial for its ZyCov-D vaccine at around 50 clinical trial sites across the country. This trial was conducted at the time when the second wave of Covid-19 was at its peak. Hence, the company believes that this ‘reaffirms’ the vaccine’s effectiveness against the Delta variant.
Zydus Cadila managing director Dr Sharvil Patel stated that the data collected by them was at the peak of April, May and June. He further stated that, if needed, the company will target other variants of concern and variants of interest that become more infectious or virulent in nature.
The plan ahead:
Zydus Cadila is geared to set up a new facility in order to manufacture up to 120 million doses per year. This implies that up to 40 million people can be vaccinated with three shots of the ZyCov-D vaccine in a year. The company aims to produce around 10 million doses every month and also hopes to supply 50 million doses to the country by the end of the year.