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 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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News Network
November 12,2024

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The UN humanitarian coordinator for Lebanon has warned that the “picture of life in Lebanon remains grim,” highlighting an "alarming" level of human suffering and significant humanitarian consequences due to the ongoing Israeli carnage.

Imran Riza, the UN Deputy Special Coordinator and Resident and Humanitarian Coordinator for Lebanon (UNSCOL), provided a stark overview of the Arab country's dire circumstances in a statement released on Monday.

“The current picture of life in Lebanon remains grim. Yesterday, airstrikes reportedly killed 23 people, including seven children, in the village of Aalmat in Mount Lebanon,” Riza said on X.

An airstrike in the city of Tyre on the same day resulted in the tragic deaths of five siblings from a single family, all of whom had special needs, according to his statement.

He added that in the last week, Israeli airstrikes have killed at least 241 individuals and left 642 others injured in Lebanon, as reported by the Ministry of Health.

“In the past month, more than 185,000 people have fled their homes in their search for safety within the country, bringing the total to over 870,000 people internally displaced,” Riza said

The UN official highlighted that numerous individuals, including the elderly and those with health issues, are staying behind while witnessing the ruins of their ancestral homes.

He urged for the swift safeguarding of civilian people and infrastructure, emphasizing the necessity to uphold international humanitarian law and end the ongoing violence.

Lebanon’s National News Agency reported that Israeli forces bombed a house in the town of Maydoun in Bekaa on Monday night, killing three people and destroying the house.

Earlier, Israel bombed the northern town of Ain Yaaqoub, killing at least 14 people.

The killings came as Israeli military continued to pound Lebanon, bombing shops selling electrical appliances in the southern city of Tyre and carrying out air raids on the towns of Shamshtar in eastern Baalbek and Roumine in southern Nabatieh.

Lebanon’s Ministry of Health said Israeli attacks killed at least 54 people across the country on Monday.

Israel’s merciless attacks continue despite calls from the UN Security Council for an immediate ceasefire and directives from the International Court of Justice urging measures to prevent genocide and alleviate the dire humanitarian situation in Gaza and Lebanon.

In Lebanon, at least 3,243 people have been killed and 14,134 others wounded in Israeli attacks since the war on Gaza began on October 7, 2023.

The Lebanese resistance movement Hezbollah opened a support front for Palestinians in Gaza only a day after the Israeli regime unleashed its genocidal war on the besieged territory.

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News Network
November 13,2024

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Bengaluru: An estimated overall 10.14 per cent voter turnout was recorded during the first two hours, since the voting began for bypolls to three Assembly segments in Karnataka on Wednesday, election officials said.

The voting began at 7 am and will go on till 6 pm.

More than seven lakh voters are eligible to cast their votes in about 770 polling stations in Shiggaon, Sandur and Channapatna, where a total of 45 candidates are in the fray.

While Channapatna recorded 10.34 per cent voter turnout till 9 am, it was 10.08 per cent in Shiggaon, and 9.99 per cent in Sandur, election officials said.

Voters, including women and elderly were seen queuing up in front of polling booths in these segments.

By-polls for Sandur, Shiggaon, and Channapatna are necessitated, as the seats fell vacant following the election of their respective representatives -- E Tukaram of Congress, former CM Basavaraj Bommai of BJP, and Union Minister H D Kumaraswamy of JD(S) -- to Lok Sabha in May elections.

As many as 31 candidates are in the fray from Channapatna, while Sandur and Shiggaon have six and eight contenders, respectively.

Elaborate security arrangements have been made in the three segments for the smooth conduct of the polls.

The by-polls will witness a straight fight between the ruling Congress and BJP in Sandur and Shiggaon segments, while in Channapatna, JD(S) which is part of the NDA alliance is in contest against the grand old party.

Among the three segments, Channapatna is considered to be a "high profile", where the contest is between C P Yogeeshwara, a five time MLA from the segment and former Minister, who joined the Congress quitting BJP ahead of nomination, and actor-turned -politician Nikhil Kumaraswamy, who is Kumaraswamy’s son and former PM H D Deve Gowda's grandson.

BJP's Bharath Bommai, son of Basavaraj Bommai, is fighting Congress Yasir Ahmed Khan Pathan, who had faced defeat against the former Chief Minister in the 2023 Assembly polls, in Shiggaon.

Bharath Bommai and his father cast their vote at a polling booth in Shiggaon segment.

In Sandur, Bellary MP Tukaram's wife E Annapurna of Congress is contesting from the seat vacated by her husband, against, BJP ST Morcha president Bangaru Hanumanthu, who is considered close to party leader and former mining barron G Janardhan Reddy.

Annapurna, Tukaram and other family members cast their votes at a booth in the segment.

With Nikhil Kumaraswamy and Bharath Bommai contesting, the third generation of Gowda and Bommai families are in the fray in this by-poll. Both their fathers and grandfathers have served as Karnataka's Chief Ministers in the past.

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