New Delhi: Amid an ongoing struggle to vaccinate all above 18, Bharat Biotech was on Tuesday recommended by an expert panel to send its COVID-19 vaccine ‘Covaxin’ for phase II and phase III clinical trial on children between the age of two and 18 years. An approval to vaccinate the younger population would be a major breakthrough as it would mean reopening of schools and normal classes.Also Read - Breaking News LIVE: PM Modi to Visit Rajkot in Gujarat Today
The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) 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. Also Read - Delhi Witnesses Marginal Dip in Covid Numbers, Registers 403 Fresh Cases; Positivity Rate Stands At 1.76%
The trial will take place in 525 subjects at various sites, including AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur, officials said. Also Read - Germany Recognises Bharat Biotech’s Covaxin For Travel Purposes. Here’s What It Means For Indians
“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,” an official told PTI.
Earlier, the proposal was deliberated in the SEC meeting dated February 24 and the firm was asked to submit a revised clinical trial protocol.
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.
However, several states are facing a shortage of vaccine supply just 10 days into the Phase 3 vaccination drive. According to the data available on the Health Ministry website, less than 25 lakh people between 18-44 age group have been vaccinated across the country so far.
Pfizer’s Coronavirus Vaccine Approved For 12 And Above in the US
The United States on Monday expanded the use of Pfizer’s COVID-19 vaccine to children as young as 12, calling it a ‘watershed moment’ to protect the nation’s teenage population before they head back to school in the fall. The US became the second country after Canada to take the decision to vaccinate the teen population.
Pfizer’s vaccine is already being used in multiple countries for teens as young as 16. Meanwhile, Moderna and Novavax have also claimed strong protection against the virus in 12- to 17-year-olds with no serious side effects in preliminary trials.
Outside of the US, AstraZeneca is studying its vaccine among 6- to 17-year-olds in Britain.