New Delhi, Aug 20 (UNI) American pharma giant Johnson & Johnson (J&J) has sought permission from India's Central Drugs Standard Control Organisation (CDSCO) to conduct a study of it's COVID-19 single shot Janssen vaccine in India in adolescents aged 12– 17 years, the firm told UNI on Friday.
"On 17 August 2021, we submitted an application to the Central Drugs Standard Control Organisation (CDSCO) to conduct a study of the Johnson & Johnson COVID-19 vaccine in India in adolescents aged 12 – 17 years," the company's spokesperson informed.
"To ultimately achieve herd immunity, it is imperative that COVID-19 vaccine clinical trials continue to move forward in this population, and we remain deeply committed to the critical work needed to make our COVID-19 vaccine equitably accessible for all age groups,” she added.
The single-shot vaccine from J&J has shown 85 per cent efficacy in preventing severe disease in its Phase 3 human clinical trials.
This is the second Covid-19 vaccine that has been granted Emergency Use Authorisation (EUA) through the fast-track approval route by the Drug Controller General of India (DCGI). The vaccine was given EUA status on August 7.
Union Health Minister Mansukh Mandaviya had announced on Twitter about the single-shot vaccine being granted the Emergency Use Authorisation in India.
“India expands its vaccine basket! Johnson and Johnson’s single-dose COVID-19 vaccine is given approval for Emergency Use in India. Now India has 5 EUA vaccines. This will further boost our nation’s collective fight against #COVID19,” Mandaviya had said in a tweet.
The firm had earlier also sought approval to conduct a phase-3 clinical trial of its vaccine on approximately 600 participants in two age groups — those aged 18 and below 60 years and those aged 60 years and above — to evaluate the safety, reactogenicity, and immunogenicity of the jab in healthy Indian adults.
However, after the liberalised vaccination policy of the Centre came into force, the firm withdrew its proposal on July 29, CDSCO's minutes of meeting noted.
The Union government changed the policy for regulatory approvals for foreign manufacturers to commercially market their Covid-19 vaccine in the country in April, waiving the pre-condition of phase 2-3 clinical trials for those vaccines that have been granted emergency approvals by regulators in the US, EU, UK, and Japan, and those listed by the WHO.
UNI/ASH RKM 1614