New Delhi: Biological E has applied for emergency use authorization from the Indian drug regulator for its COVID-19 vaccine Corbevax for the 12-18 age group, official sources said on Sunday.
The Drug Controller General of India (DCGI) has already approved Corbevax, which is India’s first locally developed RBD protein subunit vaccine against COVID-19, for restricted use in emergency situations among adults on December 28.
In a request sent to DCGI on February 9, Srinivas Kosaraju, head of Quality and Regulatory Affairs at Biological E Limited, said the company had received approval to conduct a phase 2/3 clinical study of Corbevax among children and adolescents from 5 to 18 years old in September.
“Based on the no-objection certificate, Biological E initiated the clinical study in October 2021 and evaluated the available safety and immunogenicity results from the ongoing phase 2/3 study, which indicated that the vaccine is safe and immunogenic.
“The proposed application is to obtain permission for restricted use in an emergency situation in adolescents aged 12 to less than 18 years based on interim results (from the ongoing phase 2/3 clinical study) taking into account the current pandemic and the spread of COVID-19 vaccine in India,” Kosaraju said in the application.
The Corbevax vaccine is administered intramuscularly with two doses scheduled 28 days apart and stored at temperatures between 2 and 8 degrees Celsius and is supplied in vials of 0.5 ml (single dose) and 5 ml (10 doses).
According to the Ministry of Health, the company has conducted phase 1/2, 2/3 clinical trials of its COVID-19 vaccine in the country. In addition, it has conducted a phase 3 active comparison clinical trial to assess superiority over the Covishield vaccine, he said.