India saw a record of 4,205 COVID-19 fatalities in a day taking the death toll to 2,54,197, while 3,48,421 new coronavirus infections were reported, according to the Union Health Ministry data updated on Wednesday. India launched the ‘world’s largest vaccination drive’ on January 16 with the two vaccines Covaxin and Covishield. The total tally of COVID-19 cases in country now stands at 2,33,40,938. The active cases have reduced to 37,04,099 comprising 15.87% of the total infections, while the national COVID-19 recovery rate has improved to 83.04%, the data updated at 8 am showed.
Meanwhile, India’s Bharat Biotech has finally announced interim Phase III data for its Covid-19 shot, with the vaccine showing 78% efficacy at preventing mild, moderate and severe coronavirus infections and working well against most variants.
Bharat’s second interim analysis is based on accruing more than 87 symptomatic cases of Covid-19. Due to India’s recent surge in cases, 127 symptomatic cases were recorded, resulting in a point estimate of vaccine efficacy of 78% against mild, moderate, and severe Covid-19.
Covaxin, India’s first domestically-developed Covid-19 vaccine, is a two-dose jab that uses an inactivated or “dead” form of the virus. The shot also showed 100% efficacy at preventing severe Covid-19 and hospitalisations, according to a joint statement from Bharat and co-developers, the Indian Council of Medical Research (ICMR). “Efficacy against SARS-Cov-2 has been established,” said Bharat Biotech’s chairman and managing director Dr Krishna Ella. “Covaxin has demonstrated an excellent safety record in human clinical trials and in usage under emergency use.”
“Covaxin is now a global innovator vaccine derived from research & development from India. The efficacy data against severe Covid-19 and asymptomatic infections is highly significant, as this helps reduce hospitalisations and disease transmission, respectively.”
Health experts have warned that children below 18 years would be at risk in the third wave of Covid-19, which may hit India in 3-4 months. The main reason being cited is that they are yet to be inoculated against the infection. As per trusted sources, Bharat Biotech’s Covaxin shot on Tuesday has been recommended by the expert panel on Covid-19 for further trials on children aged between 2 and 18 years. Covaxin, indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), is being used in adults in India’s ongoing COVID-19 vaccination drive.
“After detailed deliberation, the committee recommended for conduct of proposed phase II/III clinical trial of whole virion inactivated coronavirus vaccine in the 2 to 18 years age group subject to the condition that the firm should submit the interim safety data of phase II clinical trial along with DSMB recommendations to the CDSCO before proceeding to phase III part of the study,” a source said.
The trial will take place in 525 subjects at various sites, including AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur.
The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) on Tuesday deliberated upon Hyderabad-based Bharat Biotech’s application seeking permission to conduct phase II/III clinical trials to evaluate the safety, reactogenicity and immunogenicity of Covaxin jabs in children aged 2 to 18 years.
Earlier the proposal was deliberated in the SEC meeting dated February 24 and the firm was asked to submit a revised clinical trial protocol.
