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First Covid-19 vaccine for children above 12 years gets emergency use nod

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Guwahati: Gujarat-based Zydus Cadila’s three-dose Covid-19 vaccine was on Friday granted emergency use authorisation for use in adults and children above 12 years, making it potentially the first vaccine to be administered to the adolescent population in India.

With the central drug regulator clearing the vaccine, Zydus Cadila’s ZyCoV-D is set to become the first Covid vaccine candidate developed on a plasmid DNA platform to be commercially introduced anywhere in the world.

The vaccine, jointly developed in partnership with the Department of Biotechnology, had demonstrated a primary efficacy of 66.66 per cent in phase 3 clinical trials. It was the first Covid-19 vaccine in India to be tested in the adolescent population — those in the 12-18-year age group.

While the vaccine has been approved for use in the adolescent population, it’s for the government to take a call on whether to roll out the vaccination drive for this age group.

ZyCoV-D is the world’s first Covid-19 vaccine built on a DNA platform to be granted emergency use authorisation. Unlike mRNA vaccines, DNA-based vaccines do not require ultra-cold storage systems and are said to be more cost-effective. Zydus also claims that its technology is ideal for tackling Covid-19 as it can be easily adapted to deal with mutations in the virus.

So far, there are three vaccines that are being used in India’s immunisation drive — SII’s Covishield, Bharat Biotech’s Covaxin and Russia’s Sputnik V. Moderna’s mRNA vaccine and the single-dose vaccine developed by Johnson & Johnson have also received EUA, but they are not being used in the vaccination drive yet.

Top government sources said the Zydus DNA Covid-19 vaccine is likely to arrive in the market by October. In July, Zydus had said that it plans to manufacture 10-12 crore doses annually.

ZyCoV-D, which uses the ‘plug and play’ technology, has a DNA plasmid vector that carries the gene encoding the spike protein present on the surface of SARS-CoV-2, which causes the Covid-19 infection. When the DNA plasmid is injected into the human cell, it enters the nucleus and reproduces spike proteins. In response, the human body generates antibodies.

Zydus also claims that its technology is “ideally” suited for tackling Covid-19 as it can be easily adapted to deal with mutations in the virus, such as those already occurring. Friday’s approval comes on the basis of data generated from the largest clinical trial for a Covid-19 vaccine in India, with over 28,000 participating in phase-III of clinical trials.

The DNA vaccine platform has, broadly, three advantages. First, it is an intradermal vaccine, which is applied using the needle-free system, resulting in a reduction in side-effects such as pain at the injection site.

Second, unlike m-RNA vaccines, which need ultra-cold storage systems, the DNA vaccines can be stored at 2-8 degrees Celsius that is best suited for India’s cold storage requirement.

Third, the vaccine manufacturing facility does not require the setting up of BSL-3 high containment facility as is required in the production of inactivated virus vaccines like Covaxin. Instead, the vaccine can be manufactured with minimum biosafety requirements.

“Double good news for the [email protected]_INDIA_INF approves the 1st DNA-based, needle-free #COVID19 vaccine in the world – ‘ZyCov-D’… Making children of India COVID-safe, this vaccine can be used for individuals aged 12 and above. ZyCov-D is the 6th approved #COVID19 vaccine in India, and the 2nd indigenously developed one. PM @NarendraModi Ji’s vision of #AatmanirbharBharat and Make in India delivers another significant accomplishment!,” Mandaviya said in a tweet.

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