BE's Corbevax gets approval from DCGI for emergency use on kids aged 12-18 years

India's drug regulator, Drugs Controller General of India (DCGI) on Monday, granted Emergency Use Authorisation (EUA) to indigenously made Corbevax. In an attempt to vaccinate children aged 12 -18 years, a Hyderabad-based pharmaceutical company Biological E Limited (BE) developed the Receptor-Binding Domain (RBD) protein sub-unit coronavirus vaccine. Notably, Corbevax is also India's third homegrown vaccine.

India gears up to vaccinate its little citizens

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Based on the results of the Phase II/III clinical study, Biological E Ltd received consent for restricted use in an emergency situation in children aged 12 to 18 years. Back in September 2021, Corbevax was approved for restricted use in an emergency situation for children aged 5 to 18 years and later in December for adults.

With the No-objection Certificate (NoC) in their kitty, BE Ltd commenced 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 immunogenic and safe for use.

Inching toward finishing the global fight against the COVID-19

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Like most other vaccines, children will now be inoculated with the anti-COVID-19 vaccine, Corbevax through the Intramuscular (IM) route with two doses of 0.5ml each. The inoculation period is set as similar to the adult inoculation period, i.e., two doses administered 28 days apart.

The company plans to complete production at a rate of 75 million doses per month, anticipating reaching production at 100+ million doses per month from February 2022. Meanwhile, Zydus Cadila's three-dose COVID-19 vaccine ZyCoV-D was the first homegrown COVID vaccine for children to get approval from the DCGI (for use on all individuals above the age of 12). On Monday, the Serum Institute of India (SII) to0 also sought emergency use authorisation from India's drug regulator for its COVID-19 vaccine Covovax for the 12 to 17 year age group.

Notably, India has started rolling out vaccines for children aged 15-17 only in January. As per CoWin data, so far over 7,74,32,312 children in the said age group have been vaccinated, using mostly Bharat Biotech’s Covaxin.