Biological E’s Corbevax vaccine gains expert panel approval for adolescents: report
A panel of experts from the country’s central medicines authority on Monday recommended granting restricted emergency use authorization to Biological E’s COVID-19 vaccine, Corbevax, for the age group of 12 to 18. years under certain conditions, official sources said.
The government has still not made a decision on the vaccination of children under 15. In a press conference, VK Paul, member of NITI Aayog (Health), recently said that the additional need for vaccination and inclusion of the population for vaccination is constantly discussed.
The Drug Controller General of India (DCGI) has already approved Corbevax, which is the first locally developed RBD protein subunit vaccine against COVID-19, for restricted use in emergency settings in adults on December 28 .
He was not included in the country’s vaccination campaign.
“The CDSCO COVID-19 Subject Matter Expert Committee (SEC) that deliberated on the application recommended granting Restricted Emergency Use Authorization to Biological E’s Corbevax for the age group from 12 to under 18 under certain conditions,” a source said.
The recommendation was forwarded to the DCGI for final approval.
In an application 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 in children and adolescents aged 5 to 18. 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 seeks restricted emergency use authorization in adolescents 12 to less than 18 years of age based on interim results (from the ongoing Phase 2/3 clinical study) account given the current pandemic and the spread of the COVID-19 vaccine in India,” Mr. Kosaraju had said in the application.
The Corbevax vaccine is administered intramuscularly with two doses scheduled 28 days apart and is stored between 2 and 8 degrees Celsius and comes in 0.5 ml (single dose) and 5 ml (10 doses) vials.
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. Additionally, it conducted an active-comparator Phase 3 clinical trial to assess superiority over the Covishield vaccine, he said.
(Except for the title, this story has not been edited by NDTV staff and is published from a syndicated feed.)