Biological E seeks an EUA for its Corbevax vaccine for kids

Official sources claimed on Sunday that Biological E had requested emergency use authorization from India’s drug authority for its COVID-19 vaccine Corbevax for children aged 12 to 18.

On December 28, the Drugs Controller General of India (DCGI) approved Corbevax, India’s first indigenously manufactured RBD protein sub-unit vaccine against COVID-19, for limited use in adult emergency situations.

Srinivas Kosaraju, Director of Quality and Regulatory Affairs at Biological E Limited, stated in an application to DCGI on February 9 that the company had got authorisation to begin a phase 2/3 clinical research of Corbevax in children and adolescents aged 5 to 18 years in September.

“Biological E began the clinical study in October 2021, based on the no-objection certificate, and assessed the available safety and immunogenicity results from the ongoing phase 2/3 investigation, which revealed that the vaccine is safe and immunogenic.”

According to the application, “the proposed application is for obtaining permission for restricted use in an emergency situation in adolescents aged 12 to less than 18 years based on interim results (of the ongoing phase 2/3 clinical study) considering the current pandemic and widespread use of COVID-19 vaccine in India,” Kosaraju said. The Corbevax vaccine is administered parenterally in two doses 28 days apart and is stored at 2 To 8 degrees Celsius. It is available in vial packs of 0.5 ml (single dose) and 5 ml (10 doses).

The business has undertaken phase ½, 2/3 clinical trials of its COVID-19 vaccine in the country, according to the Health Ministry. It has also completed a phase 3 active comparator clinical trial to assess superiority over the Covishield vaccination, according to the company.

The trial will be conducted in ten locations.

The permission has been given to Biological E after the recommendation from the Subject Expert Committee.

The company will study the safety and tolerability of its vaccine, CORBEVAX, in this population, it added.

Six vaccinations have been approved for use in the country, but only 11.28 percent of the population has been properly vaccinated, according to data from Johns Hopkins.

The Covid-19 shots for adults, created by Bharat Biotech and Zydus Cadila, are among them.

It is to be noted that the Central Government has made an advance payment of ₹1,500 crore to Biological E for 30 crore Covid-19 vaccines.