New Delhi: Biological E has received approval to conduct human clinical testing phase II / III of Covid-19 Corbevax vaccine candidates in children over five years and adolescents, the Biotechnology Department (DBT) said on Friday.
CORBEVAX, RBD sub-unit vaccine, has been developed with the support of the Biotechnology Department and the PSU Biotechnology Industry Research Assistance (BIAC), he said.
Approval of the drug controller of India (DCGI) to conduct a trial of the Comparator and Immunogenicity Phase III in adults coming after the Subject Expert Committee (SEC) reviewed the clinical test data Phase I and II.
“In addition, biological E also accepts approval at 01.09.2021 to start the Phase II / III study to evaluate safety, reactogenicity, tolerability and immunogenicity of the Corbevax vaccine in children and adolescents,” said DBT.
Mahima Datla, Managing Director, Biological E.
Limited, said this agreement would help support the next influence with the World Health Organization (WHO) as well.
So far the noble growing, Zycov-D vaccine free of the Cadila needle has received an emergency use authorization from the drug regulator, making it the first vaccine given to the age group 12-18 years in this country.
DCGI in July has given permission to the Indian Serum Institute (SII) to conduct a phase 2/3 Covovax test in children aged 2 to 17 years with certain conditions.
The development of Corbevax is supported by the Biotechnology Department and the PSU (BIAC) Biotechnology Industry Research Assistance Council from the Preclinist Stage to Phase III Clinical Studies, DBT said.
“We are looking forward to the clinical development of Corbevax candidates for pediatrics and adults,” said Secretary DBT Renu Swarup.
Datla said, “We are happy to receive this significant agreement from DCGI.
This agreement encourages our organization to move forward and succeed in producing our Covid-19 vaccine to meet vaccination needs.” We thank BIRAC for their support and we are typical of this agreement.
Will help support our next submission with who too.
We appreciate and recognize the contribution of all our collaborators for their sustainable support in this effort, “said Datla.