ZyCoV-D: Zydus Cadila to begin vaccine trials for children aged 3-12 years
Ahmedabad-based Zydus Cadila will now apply for its ZyCoV-D COVID-19 vaccine trials in children aged 3 years to 12 years old in the next 7 to 10 days.
Zydus Cadila’s Managing Director Dr Sharvil Patel on August 21, 2021, announced that the company will now apply for COVID-19 vaccine trials in children aged 3 years to 12 years old in the next 7 to 10 days.
On availability of the three-dose ZyCoV-D vaccine, Patel informed that the vaccine roll-out could begin by mid or end of October 2021. He also mentioned Zydus Cadila’s two-shot vaccine and said that the company is in talks with SECC and regulators on the steps to build its two-dose vaccine.
Zydus Cadila’s ZyCoV-D, the world’s first plasmid-DNA three-dose COVID-19 vaccine on August 20, 2021, had received Emergency-Use Authorization (EUA) from the Drugs Controller General of India (DCGI) to be administered in children 12 years old and above.
Gujarat-based Zydus Cadila’s ZyCoV-D vaccine is now India’s first vaccine to inoculate the age group of 12 to 18 years against COVID-19. Patel mentioned that 1,400 adolescents in the age group 12 to 18 years had participated in the vaccine trials for children during which no severe side effects were reported.
The company had announced its plans on starting clinical trials soon on children 5 years old and above.
ZyCoV-D has been developed in collaboration with the Department of Biotechnology, Government of India under the ‘Mission COVID Suraksha’ and implemented through Biotechnology Industry Research Assistance Council (BIRAC).
What is ZyCoV-D vaccine and How it works?
•ZyCoV-D vaccine is India’s first indigenously developed and world’s first plasmid-DNA three-dose COVID-19 vaccine. The vaccine has developed by Ahmedabad-based Zydus Cadila. It has been approved by the Drugs Controller General of India (DGCI).
•ZyCoV-D vaccine incorporates a genetically engineered DNA code that uses non-replicating and non-integrating plasmids carrying the COVID-19 gene. The plasmids in the vaccine carry a genetic code that makes the spike protein of the SARS-CoV-2 virus to help the human immune system recognize and develop antibodies to neutralize the actual virus in case of exposure.
•ZyCoV-D vaccine is administered intradermally through a needle-free device in three doses, day zero, day 28, and day 56.
ZyCoV-D, World’s first plasmid-DNA COVID-19 vaccine approval: Significance
•Prime Minister Narendra Modi termed the approval of the ZyCoV-D vaccine as a momentous feat in the fight against COVID-19.
•Dr Renu Swarup, Chairperson, BIRAC and Secretary, DBT called it an important milestone in the Indigenous Vaccine Development Mission that positions India on the Global Map for Novel Vaccine Development.
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
ZyCoV-D vaccine: Clinical Trials, Efficacy, Safety, Storage – key highlights
•The COVID-19 Research Consortia through National Biopharma Mission supported ZyCoV-D vaccine for Preclinical studies, Phase I and Phase II clinical trials, and under the Mission COVID Suraksha for Phase III clinical trials.
•Phase III trials were conducted in over 28,000 volunteers that showed an efficacy of 66.6 per cent for symptomatic RT-PCR positive cases.
•The vaccine had earlier showcased safety, tolerability, and robust immunogenicity during the Phase I/II clinical trials that were conducted over 1,000 healthy adult volunteers on December 24, 2020.
•Clinical trials for the ZyCoV-D vaccine have been the largest vaccine trial for COVID-19 so far in India.
•ZyCoV-D vaccine can be stored at 2 to 4 degrees Celsius with no cold storage requirements.
Mission COVID Suraksha
•Mission COVID Suraksha is an Indian vaccine mission that was launched under the Atma Nirbhar Bharat package 3.0. The mission is implemented through the Biotechnology Industry Research Assistance Council (BIRAC).
•The mission aims to develop safe and efficacious COVID-19 vaccines for public health.
Biotechnology Industry Research Assistance Council (BIRAC)
•BIRAC, the Biotechnology Industry Research Assistance Council is a not-for-profit Public Sector Enterprise set up by the Department of Biotechnology (DBT), Government of India.
•The Council serves as an agency to encourage and enhance the biotechnology industry to undertake strategic innovation and research & development and offer support during the development of products needed in the country.
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