New Delhi: The Ahmedabad-based drugmaker Zydus Cadila’s Covid-19 vaccine may be available for children in the 12 to 18 age group soon, the central government has told Delhi High Court.
“Zydus Cadila has concluded its trial for children between the age group of 12 to 18 and is subject to statutory permissions,” the Centre said in an affidavit submitted on Friday.
It went on to say that vaccination is the Centre’s topmost priority and all efforts are being made to achieve 100% inoculation in the shortest time possible, keeping the availability of vaccine doses in mind.
Further, the Centre submitted that on 12 May, the Drug Controller General of India (DCG) permitted Bharat Biotech to conduct clinical trials on healthy volunteers between 2 to 18 years of age, for its Covaxin.
The affidavit was filed in the Delhi HC by the Union health ministry on a plea filed by a minor, Tia Gupta, seeking immediate vaccination of minors between 12 to 17 years.
Approval for Zydus Cadila
The Indian pharmaceutical firm had on July 1 applied for emergency use approval of its ZyCoV-D three-dose Covid-19 vaccine.
The company also submitted data evaluating a two-dose regimen for the shot. The SEC is likely to compare the data and make a decision on its go-ahead.
However, news agency ANI had reported a few days ago that a nod from the DCGI will probably take a few more days.
But if given approval, the ZyCoV-D would become the fifth vaccine cleared for use in the country after locally produced Covishield, Bharat Biotech’s Covaxin, Russia’s Sputnik V and the US-made Moderna.
Also, it will become the world’s first DNA vaccine to get the nod in any country.
Know about the vaccine
ZyCoV-D is a plasmid DNA vaccine that produces the spike protein of the SARS-CoV-2 and elicits an immune response mediated by the cellular (T lymphocytes immunity) and humoral (antibody-mediated immunity) arms of the human immune system.
The vaccine has shown the efficacy of 66.6% against symptomatic Covid cases and 100% for moderate disease.
It is an intradermal vaccine, applied using a ‘needle-free injector’. Zydus claims the needle-free system can lead to a significant reduction in side effects.
Zydus has claimed to have conducted the largest clinical trial for a Covid-19 vaccine in India in over 50 centres. This was also the first time that any Covid-19 vaccine had been tested in the 12-18-year age group in the country.
The vaccine is said to have shown safety and efficacy in a late-stage trial with more than 28,000 volunteers, including 1,000 subjects in the 12-18 year age group.