Indian drugmaker Zydus Cadila informed on July 1, 2021 that it has sought emergency use approval for ZyCoV-D-the world's first plasmid DNA COVID-19 vaccine from the Drugs Controller General of India (DCGI).
The vaccine, when approved, will be the first-ever plasmid DNA vaccine for human use. It will also be the fifth COVID-19 vaccine to get emergency use authorisation in India. India had previously approved four COVID-19 vaccines-Serum Institute of India's Covishield, Bharat Biotech's Covaxin, Russian vaccine Sputnik V and Moderna.
Zydus Cadila plans to manufacture up to 120 million doses of the shot annually. The plasmid DNA vaccine has reportedly proven its safety and efficacy standards. The DNA vaccine's efficacy is expected to be similar to that of other mRNA COVID vaccines that are already being used for immunisation around the world including Moderna, Pfizer and Johnson & Johnson.
Zydus Cadila applies for Emergency Use Authorisation (EUA) seeking approval from the Drugs Controller General of India (DCGI) for the launch of their DNA vaccine for 12 years & above. The vaccine has completed the third phase of trial.#COVID19 pic.twitter.com/LDlsSkG3zF
— ANI (@ANI) July 1, 2021
What kind of vaccine is Zydus Cadila's COVID vaccine?
Zydus Cadila's COVID-19 vaccine, ZyCoV-D is the world's first indigenously made plasmid DNA vaccine against COVID-19. It has been developed at Zydus’ Vaccine Technology Centre in Ahmedabad.
What are DNA vaccines?
The DNA and RNA vaccines are relatively new technology that don't introduce a weakened form of the pathogen like traditional vaccines but instead, they work by carrying the genetic code of the virus. The plasmid vector is taken up into cells and transcribed in the nucleus. This is transferred to another mRNA molecule, which induces a cell-mediated immune response. The DNA vaccines were developed for the first time only in the 1990s.
Are DNA vaccines effective?
The DNA vaccines produce the same results as mRNA vaccines and so the efficacy of ZyCoV-D is likely to be similar to that of other mRNA COVID vaccines already in the market including Moderna, Pfizer and Johnson & Johnson. The only advantage of DNA vaccines over mRNA vaccines is that they can be stored at higher temperatures, making them more suitable for countries like India.
How is ZyCoV-D different from Covaxin and Covishield vaccines?
ZyCoV-D is India’s first plasmid DNA vaccine, while Covaxin is an inactive virus type vaccine and Covishield is a non-replicating viral vector type vaccine. Both Covishield and Covaxin are relatively traditional. 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.
What is the dosage schedule of ZyCoV-D?
The ZyCoV-D shots will be given intradermally and not intramuscular, thus, making them painless. The vaccine will be administered in three doses in a gap of 0-28-56-days.
What is the suitable temperature for storing the vaccine?
The Zydus Cadila vaccine can be stored at a normal refrigeration temperature of 2 to 8 degrees.
How safe is ZyCoV-D?
In Phase III trials that covered more than 28,000 volunteers across the country including 1000 volunteers in the 12-18 years age group, ZyCoV-D showed both safety and efficacy.
The study was carried out during the peak of the deadly second wave of COVID-19 in India. It reaffirms the vaccine's efficacy against the new mutant strains especially the Delta variant.
Background
Cadila Healthcare Limited had announced that their vaccine for COVID-19, named ZyCoV-D in July of 2020.
The vaccine then had successfully completed preclinical development and had received permission to initiate human clinical trials.
The company submitted the results of Phase I/II clinical trials conducted over 1000 healthy adult volunteers on December 24, 2020. The vaccine received approval from the Drugs Controller General of India (DCGI) to start Phase III Clinical Trials on January 3, 2021.
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