Ella misleads again "12yrs & above we have already done a trial"
Facts: There are data for 14 kids in age grp of 12-18 yrs from the Phase 2 trial of COVAXIN
Phase 3 enrolled only 18yrs & above
Ella thinks safety/immunogenicity data for 14 kids is sufficient for use in 12yrs+ https://twitter.com/IndiaToday/status/1349367274549825538
Facts: There are data for 14 kids in age grp of 12-18 yrs from the Phase 2 trial of COVAXIN
Phase 3 enrolled only 18yrs & above
Ella thinks safety/immunogenicity data for 14 kids is sufficient for use in 12yrs+ https://twitter.com/IndiaToday/status/1349367274549825538
This is @SuchitraElla on 30 December, 3 days before COVAXIN received approval saying that no where in the world has a vaccine been tested in children.
She believed it would be used only in adults
She believed it would be used only in adults
SEC recommended granting approval to the vaccine on 2 Jan.
DCGI granted the permission on 3 Jan 2021 with indicated use as "for active immunization against Corona Virus Disease (COVID-19) for age >=12 years..."
@CDSCO_INDIA_INF
DCGI granted the permission on 3 Jan 2021 with indicated use as "for active immunization against Corona Virus Disease (COVID-19) for age >=12 years..."
@CDSCO_INDIA_INF
On 31 Oct, Raches Ella (COVAXIN project lead) said that neither he nor @BharatBiotech believes in emergency use authorisation for COVAXIN after Phase 2 results & that they were doing Phase 3 to study clinical outcomes
https://twitter.com/das_seed/status/1348242589015793719?s=20
@ICMRDELHI @drlokeshksharma @NITIAayog
https://twitter.com/das_seed/status/1348242589015793719?s=20
@ICMRDELHI @drlokeshksharma @NITIAayog