Covovax granted EUA for children aged 7-12 | Latest News India - Hindustan Times
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Covovax granted EUA for children aged 7-12

Jun 29, 2022 01:34 AM IST

The Drugs Controller General of India (DCGI), the country’s drugs regulator, on Tuesday granted emergency use authorisation (EUA) to India’s first indigenously developed mRNA vaccine against Covid-19 manufactured by Pune-based Gennova Biopharmaceuticals

The Drugs Controller General of India (DCGI), the country’s drugs regulator, on Tuesday granted emergency use authorisation (EUA) to India’s first indigenously developed mRNA vaccine against Covid-19 manufactured by Pune-based Gennova Biopharmaceuticals.

Jalandhar: A health worker administers a dose of COVID-19 vaccine to a student, amid rise in coronavirus cases, at a government school, in Jalandhar, Monday, May 2, 2022. (PTI Photo) (PTI05_02_2022_000108B) (PTI)
Jalandhar: A health worker administers a dose of COVID-19 vaccine to a student, amid rise in coronavirus cases, at a government school, in Jalandhar, Monday, May 2, 2022. (PTI Photo) (PTI05_02_2022_000108B) (PTI)

Also on Tuesday, the drugs regulator granted EUA to Covid-19 vaccine Covovax for use in children aged 7-12 years, according to people familiar with the matter, making it the third dose to be cleared for children under 12 years in India.

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Unlike other mRNA vaccines such as the ones developed by Moderna and Pfizer that need to be stored at sub-zero temperatures, Gennova’s vaccine remains stable between 2-8 °C. The company had applied for EUA for its vaccine — GEMCOVAC-19 — to the drugs regulator in March this year.

Unlike conventional immunisation models, mRNA vaccines carry molecular instructions inside the host body to make the protein through a synthetic RNA of the virus. The host body then produces the viral protein that is recognised by the immune system, thereby making the body ready to fight against the disease.

The advantage that mRNA technology offers against conventional approaches is that it allows for faster development and scale-up of production for vaccines.

Meanwhile, the announcement regarding Covovax comes four days after the central drugs standard control organisation’s subject expert committee had recommended the vaccine, the second shot manufactured by Pune-based Serum Institute of India (SII), for emergency use.

As on Tuesday, India has approved the use of coronavirus vaccines in children aged 12 and above, although not all of the approved doses are being administered to these age groups. Covovax, developed by US-based Novavax Inc, is being administered to those aged 14 years and above, Bharat Biotech’s Covaxin is given to those 15 and above, and Biological E’s Corbevax is administered to children in 12-14 age group.

SII sought approval in the form of two separate applications submitted on March 16 and June 1 with trial data of children aged 7-12 years and 2-7 years respectively.

In its previous meeting on April 29 this year, the subject expert committee of the central drugs standard control organisation sought more data from the company.

DCGI had approved Covovax for restricted use in emergency situations in adults on December 28, 2021, and in the 12-18 years age group on March 9, 2022, with certain conditions.

Experts say it has been a good idea to vaccine children even though vaccination in babies can be deferred for now.

“Children run the risk of bringing home infection and infecting others in the family, especially elderly and those with comorbidities. Therefore, it is important to vaccinate them also. As for babies, I would say, there is no immediate need and cannot be priority at the moment,” said Dr Rahul Nagpal, director, department of paediatrics, Fortis Healthcare.

Serum Institute of India locally manufactures Covovax, which is the second anti-Covid vaccine manufactured by the company after Covishield.

On December 28 last year, the Drugs Controller General of India approved Covovax for emergency use in adults, and had approved the vaccine for emergency use in those aged 12 and above in March this year, making it the fourth Covid vaccine approved for emergency use in children in this age group.

In August 2020, Novavax had announced a licence agreement with SII for the development and commercialisation of NVX-CoV2373, its Covid-19 vaccine candidate, in low and middle-income countries.

The vaccine is a protein subunit vaccine that delivers a full spike of the Sars-Cov-2 to train immunity. It is the only vaccine apart from mRNA platform doses which demonstrate an efficacy of more than 90% against the original Sars-Cov-2 virus, according to the company.

A Phase 2/3, observer-blinded, randomised, controlled study in a total of 460 Indian adolescents aged 12-18 years was conducted to evaluate the safety and immunogenicity of Covovax. The study demonstrated that Covovax was well-tolerated with a reassuring safety profile. Furthermore, the data indicated that Covovax is immunogenic in adolescents aged 12 to 18 years.

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