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 19,2024

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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 23,2024

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Bengaluru: In a boost to the ruling Congress in Karnataka, the party on Saturday swept the by-polls to three Assembly segments, causing a major setback to the BJP-JD(S) alliance in the state.

The Congress has retained Sandur, the seat considered to be its strong hold, and has also bagged Shiggaon and Channapatna segments, which were earlier held by BJP and JD(S) respectively.

The November 13 by-polls to Sandur, Shiggaon and Channapatna Assembly segments had witnessed a fierce fight between the ruling Congress and a combative BJP-JD(S) alliance.

The by-polls to Sandur, Shiggaon and Channapatna were 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 Kumaraswamy of JD(S) to Lok Sabha in May elections.

The by-polls witnessed 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 took on the grand old party.

Congress' C P Yogeeshwara won the Channapatna segment, defeating JD(S) candidate and Kumaraswamy's son Nikhil Kumaraswamy, by a margin of 25,413 votes.

Former CM Basavaraj Bommai's son Bharath Bommai of BJP faced defeat against Congress' Yasir Ahmed Khan Pathan in Shiggaon Assembly segment by a margin of 13,448 votes.

In Sandur, Congress candidate E Annapoorna, the wife of Bellary MP E Tukaram, won the seat vacated by her husband, by a margin of 9,649 votes.

Congress' win in the by-poll is seen as an endorsement of both Chief Minister Siddaramaiah and his deputy D K Shivakumar's leadership, and the government's programmes, especially the five guarantee schemes.

Nikhil Kumaraswamy and Bharath Bommai, the third generation of Gowda and Bommai family respectively, who contested this bypolls, have lost. Their fathers and grandfathers had served as Karnataka's Chief Ministers in the past.

While for Bharath Bommai this was his electoral debut, for Nikhil it was his third electoral loss.

Among the three segments, Channapatna was considered to be a high profile battle, where the contest was between C P Yogeeshwara and actor-turned-politician Nikhil Kumaraswamy.

A five-time MLA from the segment and a former Minister, Yogeeshwara had joined the Congress after quitting BJP ahead of nomination.

There were plans to field Yogeeshwara on a JD(S) ticket, but he was not interested in it, and instead wanted Kumaraswamy to support him as BJP candidate. This was not acceptable to Kumaraswamy and his party, following which Yogeeshwara jumped ship.

However, Kumaraswamy had subsequently said he had agreed to Yogeeshwara contesting from BJP, and despite that he jumped ship to Congress, under the influence of Deputy Chief Minister D K Shivakumar and his brother and former MP D K Suresh.

Nikhil had faced defeat in 2019 Lok Sabha and 2023 Assembly polls. It is seen as a setback for Kumaraswamy too, as he could not ensure son's win from the Channapatna, the seat he had twice represented in the past.

Congress' win is crucial for Shivakumar, who is also the state Congress chief and his brother Suresh to strengthen their position in their home district of Ramanagara, a Vokkaliga heartland.

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

Initially, former MLA Syed Azeempeer Khadri, a Congress' ticket aspirant, had raised a banner of revolt in Shiggaon, by filing his nomination as an independent, but later withdrew after intervention by party leadership.

In Sandur, Bellary MP Tukaram's wife E Annapurna of Congress won 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.

Sandur is a Congress' bastion, and Tukaram had represented it four times.

Congress winning the by-polls is seen as "crucial" for Chief Minister Siddaramaiah to assert himself , amid demands for his resignation following charges against him in the MUDA site allotment case.

There were also behind-the-scenes political activities within the ruling Congress earlier this year, with a few ministers in his Cabinet holding closed door meetings, fueling speculation about leadership change. But such activities came to a halt following instructions from the party high command.

It is equally important for Shivakumar, who has not shied away from openly expressing his Chief Ministerial ambitions, amid speculations over "rotational Chief Minister formula," according to which he will become CM after two-and-half years (in this govt's five years tenure), but they have not been officially confirmed by the party.

The defeat in this by-poll is seen as a setback for state BJP President Vijayendra, who has been facing intense criticism and opposition from a section within the party, who have raised a banner of revolt against his leadership accusing him and his father, veteran leader B S Yediyurappa of "adjustment politics".

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