Zydus Cadila likely to get emergency use approval this week for its COVID-19 vaccine

ZyCoV-D is the world's first indigenously made plasmid DNA vaccine against COVID-19.  It is a three-dose vaccine and will be administered in a gap of 0-28-56-days. 

Created On: Aug 9, 2021 19:10 IST
Zydus Cadila likely to get emergency use approval this week for its COVID-19 vaccine
Zydus Cadila likely to get emergency use approval this week for its COVID-19 vaccine

Zydus Cadila's three-dose COVID-19 vaccine, ZyCoV-D is expected to get emergency use approval later this week, informed sources. ZyCoV-D is the world's first plasmid DNA vaccine against COVID-19. 

Union Health Minister Mansukh Mandaviya had informed last week during the question hour in the Rajya Sabha that the government expects four more Indian pharmaceutical companies to start production of indigenous COVID-19 vaccines in October-November that will help to meet the domestic demand.

He had informed that while Zydus Cadila will soon get an emergency use nod from Expert Committee, Biological E and Novartis vaccines will also be available in the market in the coming days.

Earlier, during a press briefing as well, NITI Aayog member Dr V K Paul had said that the DCGI is examining Zydus Cadila's COVID vaccine for children. However, emergency use approval is expected to be given to adults first. The Drug Controller General of India (DCGI) had earlier asked the Ahmedabad-based firm to return with more data on its ZyCoV-D.

ZyCoV-D: Ten Facts You Must Know!

1. ZyCoV-D is the world's first indigenously made plasmid DNA vaccine against COVID-19. 

2. The vaccine's efficacy will be similar to that of other mRNA COVID vaccines including Moderna, Pfizer and Johnson & Johnson.

3. The Zydus Cadila COVID-19 vaccine will deliver a specific set of instructions to the cells that instruct our immune system to recognise and respond to the virus.

4. The main advantage of DNA vaccines is that they can be stored at higher temperatures, making them more suitable for countries like India. 

5. The Zydus Cadila vaccine can be stored at a normal refrigeration temperature of 2 to 8 degrees.

6. ZyCoV-D will be the fifth COVID-19 vaccine to get emergency use authorisation in India after Serum Institute of India's Covishield, Bharat Biotech's Covaxin, Russian vaccine Sputnik V and Moderna. 

7. The ZyCoV-D vaccine doses will be given intradermally and not intramuscular, making them painless. 

8. It is a three-dose vaccine and will be administered in a gap of 0-28-56-days. Other COVID-19 vaccines that have received emergency approval so far are mostly two dose vaccines or one dose. 

9. The phase III trials of the Zydus Cadila vaccine covered more than 28,000 volunteers across the country including 1000 volunteers in the 12-18 years age group. 

10. ZyCoV-D has reportedly showed both safety and efficacy during these trials, even against the new mutant strains especially the Delta variant.

Background 

Zydus Cadila had informed on July 1, 2021 that it has sought emergency use authorisation (EUA) for its three-dose COVID-19 vaccine ZyCoV-D from the Drugs Controller General of India (DCGI). The drugmaker plans to manufacture 10-12 crore doses annually. The drugmaker has conducted the largest clinical trial for its COVID-19 vaccine in India so far in over 50 centers.

Zydus Cadila had received permission to initiate human clinical trials last year. The company had submitted the results of Phase I/II clinical trials that were conducted over 1000 healthy adult volunteers on December 24, 2020. 

The drugmaker had received approval from the Drugs Controller General of India (DCGI) to start Phase III Clinical Trials on January 3, 2021. 

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