An expert panel associated with the Indian central drug authority has favored granting emergency use authorisation for Biological E’s COVID-19 vaccine Corbevax for children in the five to 11 years age group with certain conditions.
According to an official source, Biological E presented updated safety data two to three months after the second dosage in the proposed five to eleven years age range, as well as safety data available from the doses utilised to the higher age group.
It has also presented immunogenicity and virus neutralising antibody data against variants of concern, including the Delta and Wuhan strains, supporting its request for restricted usage in an emergency circumstance in children aged five to twelve years the source said to PTI.
Biological E has also submitted updated safety data from the immunisation programme for immunisation in the age group of 12 to 14 years, reported Hindustan Times.
The SEC noted that the interim safety and immunogenicity data of Phase 2/3 clinical trial in subjects of five to less than 12 years is comparable to that higher age groups. It also noted the safety data of vaccination in the age group of 12 to 14 years.