An expert panel of the Central Drugs Authority of India on Monday recommended restricted emergency use authorization for the biological E’s COVID-19 vaccine, Corbevax, for ages 12 to 18 years, subject to certain conditions, official sources said.
The government has not yet taken any decision on vaccinating those below 15 years of age. NITI Aayog Member (Health) VK Paul said in a recent press conference that the additional requirement of vaccination and inclusion of population for vaccination is being continuously investigated.
The Drug Controller General of India (DCGI) on December 28 has already approved Corbevax, India’s first indigenously developed RBD protein sub-unit vaccine against COVID-19, for restricted use in emergency situations in adults.
It has not been included in the country’s vaccination campaign.
A source said, “The Subject Expert Committee (SEC) on COVID-19 of CDSCO, while deliberating on the application, has decided to ban organic E. K. Recommends granting emergency use authorization.”
The recommendation has been sent to DCGI for final approval.
In an application sent to the DCGI on February 9, Srinivasa Kosaraju, Head of Quality and Regulatory Affairs, Biologicals E Ltd., said that the firm is required to conduct the Phase 2/3 clinical trial of Corbevax among children and adolescents aged 5-18 years. Approval was given to conduct the study. in September.
“Based on the no-objection certificate, Biological E began clinical studies in October 2021 and evaluated the available safety and immunogenicity results of the ongoing Phase 2/3 study, indicating that the vaccine is safe and immunogenic. .
“The proposed application is based on interim results (of the ongoing Phase 2/3 clinical study) given the current pandemic and the widespread COVID-19 vaccine for restricted use in emergency situations in adolescents aged 12 to 18 years.” Permission is to be obtained. In India,” Kosaraju had said in the application.
Corbevax vaccine is administered via the intramuscular route with two doses for 28 days and is stored at 2 to 8 °C and as a 0.5 ml (single dose) and 5 ml (10 dose) vial pack. is presented in.
According to the Health Ministry, 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 comparator clinical trial to evaluate the superiority against the Kovidhield vaccine, it said. PTI PLB RAR
This story has been published without modification in text from a wire agency feed. Only the title has been changed.
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