Biological E seeks EUA for its Corbevax vaccine for 12-18 yrs age group

Official sources reported on Sunday that Biological E has requested emergency use authorization from India’s medicines authority for its Covid-19 vaccine Corbevax for children aged 12 to 18.

On December 28, the Drugs Controller General of India (DCGI) authorised 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.

“Based on the no-objection certificate, Biological E has initiated the clinical study in October 2021 and has evaluated the available safety and immunogenicity results of the ongoing phase 2/3 study, which indicated that the vaccine is safe and immunogenic.

“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 of Covid-19 vaccine in India,” Kosaraju said in the application.

The Corbevax vaccine is administered through intramuscular route with two doses scheduled 28 days apart and is stored at 2 to 8 degrees Celsius temperatures and presented as 0.5 ml (single dose) and 5 ml (10 doses) vial pack.

According to the Health Ministry, the company has conducted phase 1/2, 2/3 clinical trials of its Covid-19 vaccine in the country. Further, it has conducted a phase 3 active comparator clinical trial to evaluate superiority against Covishield vaccine, it said.

Medically Speaking Team

Recent Posts

ANTIBIOTIC MISUSE IN INDIA: HOW IT’S MAKING INFECTION TREATMENT MORE CHALLENGING

Antibiotic use has surged globally, leading to a rise in antibiotic resistance, especially concerning in…

4 hours ago

CHILD DIES FROM CHOKING ON CANDY: HOW TO SAFEGUARD AGAINST CHOKING HAZARDS IN YOUNG CHILDREN

Choking is a leading cause of injury and death in young children, particularly those under…

6 hours ago

Video: How Hard Water Leads to Hair Fall and Expert Tips to Combat It

Hard Water (Khara Pani) Leading To Hair Fall Hard water is rich in minerals and…

7 hours ago

“How High Blood Pressure During Pregnancy Is Rising: What Every Expectant Mother Should Know”

Discover how the rise in high blood pressure during pregnancy is impacting maternal and fetal…

7 hours ago

“Revitalize Your Weight Loss Journey: 6 Powerful Homemade Drinks to Naturally Melt Away Fat!”

"Discover the transformative power of six delicious homemade drinks that can help you naturally melt…

8 hours ago

“Revitalize Your Weight Loss Journey: 8 Powerful Fat-Flushing Drinks to Boost Your Results!”

"Transform your weight loss routine with these eight delicious fat-flushing drinks that not only hydrate…

8 hours ago