India allows Serum Institute to enrol 7-11 years of age in Novavax Covid vaccine trial
In this Wednesday, Oct. 7, 2020, file image, a vial of the Phase 3 Novavax coronavirus vaccine is seen all set for use in the trial. (Image: AP) Bengaluru: The country’s drug regulator today enabled vaccine maker
Serum Institute to register kids aged 7-11 years for its trial of US drugmaker Novavax’s COVID-19 vaccine. “After detailed consideration, the committee recommended for permitting enrolment of subjects of 7 to 11 years of age group as per the protocol,” a subject specialist panel of the Central Drugs Standard Control Organisation stated.
Serum Institute is already carrying out a trial of its COVID-19 vaccine Covovax, a locally produced version of Novavax’s shot, in the 12-17 age and has actually presented safety information for an initial 100 participants.The Novavax vaccine is yet to be approved approval by the health authorities.
Previously this month, Serum Institute chief Adar Poonawalla said he anticipates Covovax to be approved for those listed below 18 years in January or February next year.
Up until now, only drugmaker Zydus Cadila’s TNN COVID-19 vaccine has actually gotten emergency situation use approval in the nation to be used in grownups and children aged 12 years and above.
Released at Wed, 29 Sep 2021 00:35:33 -0500