Drug Approval | September 01, 2022
Biological E. announces CDSCO recommendation of its infant’s vaccine
Subject Expert Committee(SEC) of Central Drugs Standard Control Organization (CDSCO)
Subject Expert Committee(SEC) of Central Drugs Standard Control Organization (CDSCO)
The move comes a few weeks after receiving the EUA for children between the ages of 5 and 12
Primarily set up to address the Covid-19 emergency, the WHO technology transfer hub has the potential to expand manufacturing capacity for other products as well, including treatments, and target other priorities such as malaria, HIV and cancer
To date, 30 crore vaccines have been produced as part of the commitment made to the Government of India
The Subject Expert Committee has recommended grant of permission to conduct Phase 3 trials under certain conditions
Support from DFC will help produce one billion vaccine doses by the end of 2022
The trial will be conducted across 10 sites in India
The early-stage study will test the drug’s safety, tolerability and biological effects in humans
The FDA designation follows visual-function results from the Phase 2 ACUITY trial
The companies aim to expand treatment options for millions living with metabolic disorders
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