In a statement, the American pharma company said it had been “imperative” to confirm all sections of the population, including children, were vaccinated against the virus at the earliest.
Johnson & Johnson has submitted an application to the Central Drugs Standard Control Organisation (CDSCO) to conduct a study of its vaccine against the coronavirus (Covid-19) disease in India among adolescents aged 12-17 years.
In a statement released on Friday, the American pharmaceuticals company reportedly said it had submitted its application to the Indian drug regulator on Tuesday. It further said it had been “imperative” to make sure all sections of the population, including children, were vaccinated against the virus at the earliest.
“To ultimately achieve herd immunity it’s imperative that COVID-19 vaccine clinical trials still move forward during this population, and that we remain deeply committed to the critical work needed to form our COVID-19 vaccine equitably accessible for all age groups,” the statement added.
Johnson & Johnson’s single-dose vaccine was granted approval for emergency use in India on August 7 after applying for approval from CDSCO on August 5. It had made the submission supported “topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial”. The trials had showed the single-shot vaccine was 85 per cent effective in preventing severe cases of coronavirus disease across all the regions that were studied.
The vaccine also demonstrated protection against coronavirus-related hospitalisation and death, beginning 28 days after vaccination.
Before this, the corporate had withdrawn its proposal seeking accelerated approval of its Covid-19 vaccine within the country, without giving additional details.
The government had earlier said inoculation of youngsters against the virus is probably going to start very soon. On Thursday, Bharat Biotech’s manager Krishna Ella said the trial phase of clinical studies in volunteers within the 2-18 people has been completed and therefore the vaccination drive may start as early September.
There are two vaccine candidates that are tested among children in India: Bharat Biotech’s Covaxin and Zydus Cadila’s ZyCov-D. The Covaxin trial includes 525 volunteers while ZyCov-D’s trials – as a part of the phase II/III clinical studies – includes 1,000 volunteers within the 12-18 cohort.
