Biological E’s Corbevax gets DCGI nod based on interim results from phase 2/3 studies

Mumbai, NFAPost: A third Covid-19 vaccine for children has now obtained the Indian drug regulator’s nod. Biological E’s (BE) receptor-binding domain (RBD) protein sub-unit vaccine against Covid-19 has been granted an emergency use authorisation (EUA) from the Drugs Controller General of India (DCGI). based on interim results of the ongoing phase-2 and 3 clinical study.

Cadila Healthcare’s ZyCoV-D and Bharat Biotech’s Covaxin are two vaccines that have already been approved in this category. Of these, Covaxin is already in use for vaccinating adolescents 15-17 years.

Covaxin got a recommendation for approval to be used in children as young as two year olds from the Subject Expert Committee (SEC) last October. In December, however, the DCGI decided to give its nod for use of Covaxin in 12-18 years.

The Centre has just begun administering ZyCoV-D in adults. However, the vaccine is not used for adolescents as of now. Sources had indicated that the National Technical Advisory Group on Immunisation in India (NTAGI) had not initially recommended its use in adolescents, and wanted to see the results in adults.

However, the vaccine think tank has now given its nod for use of ZyCoV-D in children too, sources in the know claimed.

One has to now see how soon Corbevax is used in adolescents. The decision will lie with NTAGI which is meeting regularly to discuss vaccination strategy.

As of now, India has not begun vaccinating children below 15 years. Since January 3, over 20 million children between 15-17 years have been fully vaccinated, and around 70% have received at least one dose. According to the Registrar General of India, the estimated population of beneficiaries in the age group of 15-18 years is 74 million for 2021-22.

Corbevax is already approved for adults and the company has started supplying the vaccine to the Centre this month. The Health Ministry had placed advanced orders for 300 mn doses last year for Corbevax.

Mahima Datla, Managing Director, Biological E. Limited, said, “We are pleased with this significant development, which helps extend the reach of our vaccine to the age group of 12 to 18 years in our country.”

Last September, BE received approval to conduct a Phase II/III clinical trial on Corbevax in children and adolescents aged 5 to 18 years. Based on the no-objection certificate, BE initiated the clinical study in October 2021 and evaluated the available safety and immunogenicity results of the ongoing phase II/III study, which indicated that the vaccine is safe and immunogenic.

The Corbevax vaccine is administered through an intramuscular route with two doses scheduled 28 days apart and is stored at 2 to 8 degrees’ Celsius temperature.

BE conducted phase-1/2, 2/3 clinical trials of its Corbevax vaccine for adults in the country. In addition, it conducted a Phase III active comparison clinical trial to evaluate superiority over Covishield vaccine.

· Corbevax gets DCGI nod for use in 12-18 years

· Covaxin and ZyCoV-D have DCGI nod for use in this age group

· Only Covaxin in use for vaccinating 15-17 yrs

· 70% children between 15-17 yrs have got at least 1 dose

· Biological E started trials on 5-18 yrs in October 2021

· DCGI approval based on interim results from phase 2/3 studies

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