DCGI's EUA nod to Covovax for 12-17 years age group
New Delhi: India's drug regulator has granted restricted emergency use authorisation to Serum Institute's COVID-19 vaccine Covovax for the 12-17 years age group subject to certain conditions.
Confirming the DCGI approval, Serum Institute of India CEO Adar Poonawalla on Tuesday tweeted:"@SerumInstIndia's brand Covovax has completed bridging studies in India and has been granted Emergency Use Authorisation by DCGI for adults and for children above the age of 12. Younger age groups will follow shortly."
It is the fourth vaccine to receive the regulator's nod for use among those below 18 years. However, only one vaccine --Bharat Biotech's Covaxin-- is used for the 15-18 years age group in the vaccination drive in the country after the government approval.
The Drugs Controller General Of India's (DCGI) approval comes after the Subject Expert Committee on COVID-19 of the CDSCO last week recommended granting emergency use authorisation (EUA) to Covovax for those aged 12 to 17. The government has still not taken a decision on vaccinating those aged below 15 years and the health ministry has consistently said that additional need for vaccination and inclusion of population for vaccination are examined constantly.
Meanwhile, Chairing a high-level meeting to review the Covid situation, Prime Minister Narendra Modi Wednesday lauded the collaborative efforts by the Union and state governments along with active participation of citizens in tackling the virus.
India's consistent efforts towards the vaccination campaign and an analysis of vaccine effectiveness to aid the lesser hospitalisation and low severity and mortality during the recent surge caused by Omicron variant was also highlighted in the meeting, the PMO said.
It emerged in the review meet that pro-active and collaborative efforts led by the Central government helped in the effective management of the spread of infection, it said.
It was also noted that India's pandemic response and vaccination efforts have been lauded globally by the WHO, United Nations, International Monetary Fund as well as in the reports of Harvard Business School and Institute for Competitiveness, the PMO said.
Appreciating the relentless efforts put in by vaccinators, healthcare workers, and Central and state governments, Modi underlined the significance of following Covid-related protocols and urged continued support from the community and participation of individuals to get vaccinated and follow Covid-appropriate behaviour, it added.
The meeting also took stock of the status of the vaccination drive in the country, and a detailed presentation on the pandemic situation globally and in India was also made.
Home Minister Amit Shah and Health Minister Mansukh Mandaviya attended the meeting besides a number of senior government officials.
The meeting came amid a steady decline in the number of COVID-19 cases nationwide, with most of the restrictions lifted.
India logged 4,575 new coronavirus cases, taking the total tally to 4,29,75,883, while the active cases dipped to 46,962, according to the Union Health Ministry data updated on Wednesday. The death toll climbed to 5,15,355 with 145 fresh fatalities, the data updated at 8 am stated.