SII’s Covovax gets EUA nod for 12-17 years age group

News Network
March 9, 2022

India's drug regulator has granted restricted emergency use authorisation to Serum Institute of India's Covid-19 vaccine Covovax for the 12-17 years age group subject to certain conditions, official sources said on Wednesday.

It is the fourth vaccine to receive the regulator's nod for use among those below 18 years.

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 not taken a decision on vaccinating those aged below 15 years. The health ministry has consistently said that additional need for vaccination and inclusion of population for vaccination are examined constantly.

In the EUA application to DCGI, Prakash Kumar Singh, director (government and regulatory affairs) at SII on February 21 had stated that the data from two studies on about 2707 children aged 12 to 17 years show that Covovax is highly efficacious, immunogenic, safe and well tolerated in this age group of children.

"This approval will not only be beneficial for our country alone, but will benefit the entire world, fulfilling our prime minister's vision of 'making in India for the world'. In line with the philosophy of our CEO, Dr Adar C Poonawalla, we are sure that Covovax will play an important role to protect children of our country and world at large against Covid-19 disease and will keep our national flag flying high globally," an official source had quoted Singh as having stated in the application.

The DCGI has already approved Covovax for restricted use in emergency situations in adults on December 28. It has not yet been included in the country's vaccination drive.

The DCGI on February 21 granted restricted EUA to Biological E's Covid-19 vaccine Corbevax for the 12 to less than 18 years age group subject to certain conditions.

Covovax is manufactured by technology transfer from Novavax and is approved by the European Medicines Agency for conditional marketing authorisation and also granted emergency use listing by WHO on December 2017, 2020. 

India has been using Bharat Biotech's Covaxin to vaccinate adolescents between 15-18 years.

ZyCov-D is the first vaccine cleared by India's drug regulator for inoculation of those aged 12 years and above in August last year. Indigenously-developed Covaxin received approval for emergency use in 12 to 18 in December last year.

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News Network
November 25,2024

Udupi: Six junior artists from the prequel of Kannada blockbuster film ‘Kantara’ were injured, when the bus they were travelling in overturned in the district, police said on Monday.

According to police, the accident occurred near Jadkal on Sunday night when the mini-bus carrying the crew of the film overturned.

“The incident happened while they were returning to Kollur after completing the shoot at Mudoor in Jadkal. The mini-bus was carrying 20 junior artistes when it met with the accident,” a police officer said.

The injured were rushed to hospitals in Jadkal and Kundapur for treatment, they said.

The Kollur police are investigating the matter.

"The news making rounds is completely false. The Kantara: Chapter 1 team began shooting at 06:00 AM today, and everything is proceeding as normal. A minor accident occurred 20 kilometres away from the shooting location, involving a local bus carrying some members of the Kantara team. However, no injuries were reported," a source close to the production said.

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News Network
November 25,2024

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Bengaluru: Karnataka Chief Minister Siddaramaiah has instructed the Hindu Religious Endowment Department to submit a proposal for constructing a gold chariot for the presiding deity of the state, Chamundeshwari, official sources said on Monday.

The directive follows a request from Member of Legislative Council (MLC) Dinesh Gooligowda, who highlighted the historical and cultural significance of the Chamundeshwari Temple on Chamundi Hill in Mysuru, which dates back to the 12th century AD.

Gooligowda noted that the existing wooden chariot, donated by devotees from Coimbatore, Tamil Nadu, has deteriorated over time.

“Devotees have expressed their desire to organise a ‘rathotsava’ using a gold chariot for Goddess Chamundeshwari. This proposal has been under consideration for some time, with an estimated cost of Rs 100 crore,” the MLC said.

He emphasised that the government’s financial involvement would not be required, as devotees are willing to contribute towards making the chariot a reality.

Gooligowda proposed a deadline for the 2025 Dasara festival for the completion of the chariot, ensuring it is ready for the grand procession featuring the idol of Chamundeshwari.

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News Network
November 15,2024

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Union minister Amit Shah on Friday, November 15, said PM Narendra Modi will amend the Waqf Act despite opposition from leaders like Uddhav Thackeray and Sharad Pawar.

"Modi ji wants to change the Waqf Board law, but Uddhav ji, Sharad Pawar and Supriya Sule are opposing it," Shah said, addressing a rally at Umarkhed in Maharashtra's Yavatmal district.

"Uddhav ji, listen carefully, you all can protest as much as you want, but Modi ji will amend the Waqf Act," he said. Shah said there are two camps in the November 20 Maharashtra assembly polls, one of 'Pandavas' represented by the BJP-led Mahayuti and the other of 'Kauravas' represented by Maha Vikas Aghadi.

"Uddhav Thackeray claims that his Shiv Sena is the real one. Can the real Shiv Sena go against renaming Aurangabad to Sambhajinagar? Can the real Shiv Sena go against renaming Ahmednagar to Ahilyanagar? The real Shiv Sena stands with the BJP," Shah said.

"Rahul Baba used to say that his government would credit money in the accounts of the people instantly. You were unable to fulfil your promises in Himachal, Karnataka, and Telangana," he said.

Shah said the Mahayuti alliance has promised that women will get Rs 2,100 per month under the Ladki Bahin Yojana. "Kashmir is an integral part of India and no power in the world can snatch it away from us," Shah said.

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