New Delhi: The American pharmaceutical company, Johnson & Johnson (J&J) in an article on Friday (August 20, 2021) mentioned that it had submitted its plea to the Central Drugs Standard Control Organisation (CDSCO) on Tuesday. In the plea, Johnson & Johnson has sought approval of the organisation to perform a study of its antibody against the COVID-19 virus in India among adolescents aged 12-17 years.
While focusing on the fact that it is “necessary” to confirm all sections of the population, including children, are vaccinated against the coronavirus as early as possible to curb the virus.
“The EUA submission is grounded on topline efficacy and safety information from the Phase 3 clinical trial ENSEMBLE, which illustrated our single-shot vaccine was 85 per cent effective in prohibiting severe disease across all regions studied, and showed safety against COVID-19 related hospitalization and death, beginning 28 days after inoculations,” the statement read.
“To ultimately achieve herd immunity it is necessary that COVID-19 vaccine clinical tests pursue to move forward in this population, and we stay deeply committed to the critical work needed to make our COVID-19 vaccine equitably available for all age groups,” the statement added.
The pharmaceutical company in its plea also said that this nod, which the company is seeking, will be a major step forward in promoting the accessibility of its Covid-19 vaccine to help conclude the pandemic.
Amid, the single-shot antibody of J&J has already been sanctioned for the Emergency Use Authorisation (EUA) through the fast-track approval route by the Drug Controller General of India.
Previously, Union Health Minister Mansukh Mandaviya had tweeted about the Emergency Use Authorisation being given to Johnson & Johnson.
Mandaviya had tweeted, “India stretched its vaccine basket! Johnson and Johnson`s single-dose COVID-19 vaccine is given endorsement for Emergency Use in India. Now India has 5 EUA vaccines. This will further enhance our nation`s collective protest against COVID19.”
The five vaccines which have been endorsed for emergency use authorization approval in India comprise Serum Institute`s Covishield, Bharat Biotech`s Covaxin, Russia`s Sputnik V, Moderna and now Johnson & Johnson (J&J).