Results of the Phase 1 study of the COVID-19 vaccine being developed by Bharat Biotech has reportedly shown long-term antibody and T-cell (immune) memory responses three months after the shot, reported India Today.
Meanwhile, the Phase 2 study for Covaxin shows there are "tolerable safety outcomes with enhanced humoral and cell-mediated immune responses". The results suggest that the antibodies may persist for six to 12 months, reported NDTV.
Covaxin is currently undergoing Phase 3 human clinical trials on 26,000 volunteers across 25 centres across India, after having undergone Phase 1 and 2 trials involving 1,000 volunteers.
In a double-blind, randomised, multi-centre Phase 2 clinical trials, a total of 380 healthy children and adults were administered two vaccine formulations four weeks apart.
In a follow-up of the Phase 1 trial, Covaxin (BBV152) produced high levels of neutralising antibodies that remained elevated in all participants three months (at day 104) after the second vaccination, reported PTI.
The Hyderabad-based Bharat Biotech on Wednesday, 23 December, applied to the Drug Controller General of India for the emergency use authorisation a second time. It had earlier applied for the same on 7 December when the Central Drugs Standard Control Organisation's (CDSCO) expert panel had recommended that the firm should present the safety and efficacy data from the ongoing Phase 3 clinical trial in the country for further consideration.
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