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J&J seeks nod from Indian regulator for clinical trial of its COVID-19 jab on adolescents aged 12-17

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New Jersey headquartered pharmaceutical giant Johnson & Johnson (J&J) has approached the Indian drug regulator seeking its nod for conducting the clinical trial for its single-shot COVID-19 vaccines on adolescents aged 12-17 years. It has filed an application with the Central Drugs Standard Control Organisation (CDSCO) seeking permission for the clinical trial.

The single-shot Janssen vaccine against COVID-19 is 85% effective in preventing severe COVID-19 disease in the phase 3 trials. The Union government has already granted emergency use authorisation (EUA) to the pharma giant for its single-shot vaccine.

In a statement, the company had then said, “We are pleased to announce that on August 7, 2021, the government of India issued Emergency Use Authorization (EUA) for the Johnson & Johnson COVID-19 single-dose vaccine in India, to prevent COVID-19 in individuals 18 years of age and older.”

Vaccines approved in India

So far, five vaccines against COVID-19 have been granted emergency use authorisation in India. It includes Serum Institute’s Covishield, Bharat Biotech’s Covaxin, Russia’s Sputnik V, Moderna and Johnson & Johnson (J&J). However, all these vaccines are meant for people aged 18 and above.

No vaccine in India has been approved for infants, children and adolescents. Bharat Biotech is also carrying out a clinical trial to ascertain the efficacy of its vaccine in children above 2 years.

COVID-19 situation in India

The health ministry on Friday informed that 36,571 fresh cases of COVID-19 have been reported in India in the past 24 hours. The addition of the fresh cases has taken the COVID-19 case tally past 3.23 crore.

The ministry also informed that over 57.22 crore COVID-19 jabs have been administered so far. Of it, over 54.71 lakh people were vaccinated on Thursday.

Also, 540 COVID-19 related deaths were reported by the ministry during this period. The addition of the fresh fatalities has taken India’s death toll due to the deadly virus to 4,33,589. Previously, the death toll had touched 4,529-mark on May 19.

 

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