Bharat Biotech's Covaxin gets nod for phase 2, 3 trials for 2 to 18-year-olds

News Network
May 12, 2021

New Delhi, May 12: An expert panel on Wednesday gave its nod to Bharat Biotech for the phase 2 and 3 human clinical trials of its Covid-19 vaccine Covaxin to be conducted on 2 to 18-year-olds, sources said.

The trial will take place in 525 subjects at various sites, including AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur.

The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organization (CDSCO) on Tuesday deliberated upon Hyderabad-based Bharat Biotech's application seeking permission to conduct phase II/III clinical trials to evaluate the safety, reactogenicity and immunogenicity of Covaxin jabs in children aged 2 to 18 years.

"After detailed deliberation, the committee recommended for conduct of proposed phase II/III clinical trial of whole virion inactivated coronavirus vaccine in the 2 to 18 years age group subject to the condition that the firm should submit the interim safety data of phase II clinical trial along with DSMB recommendations to the CDSCO before proceeding to phase III part of the study," a source said.

Earlier the proposal was deliberated in the SEC meeting dated February 24 and the firm was asked to submit a revised clinical trial protocol.

Covaxin, indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), is being used in adults in India's ongoing COVID-19 vaccination drive. 
 

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News Network
November 14,2024

Bengaluru: Karnataka Deputy Chief Minister D K Shivakumar on Thursday backed Chief Minister Siddaramaiah over his claim that the BJP had offered Rs 50 crore each to 50 Congress MLAs in an attempt to "topple" the state government.

Addressing reporters here, Shivakumar, also the Congress state president, said, “The BJP indeed lured 50 Congress MLAs with Rs 50 crore each.”

He defended Siddaramaiah’s statement and said the Congress MLAs were briefed about the BJP’s alleged 'Operation Lotus', a term used to describe the BJP's attempts to destabilise ruling governments through horse-trading.

“Some of our MLAs informed the Chief Minister about this matter, and he, in turn, shared it with the media,” Shivakumar said.

At an event in Mysuru, Siddaramaiah reiterated the claim that "none of the Congress MLAs had accepted the offer".

He also accused the BJP of filing false cases against him in a bid to "remove him and overthrow his government".

The BJP has yet to respond to the allegations.

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News Network
November 21,2024

palestainetragedy.jpg

Hamas says the Israeli regime’s sole objective lies in “erasing” the entirety of the Palestinian population from across the Palestinian territories.

Khalil al-Hayya, a ranking official with the Gaza Strip-based Palestinian resistance movement, made the remarks to the Palestinian al-Aqsa TV on Wednesday.

“The occupation targets everyone—it strikes hospitals, civil defense, women, children, and the elderly,” he said, adding that the regime sought to “empty Gaza of its residents, and displace the Palestinian people to fulfill its dreams of building a Zionist Jewish state across all of Palestine.”

The remarks came amid the regime’s October 2023-present war of genocide on the coastal sliver that has so far claimed the lives of nearly 44,000 Palestinians, mostly women and children.

“This unprecedented aggression in modern times evokes scenes from the dark ages of human history, having crossed all red lines and exceeded every expectation of brutality in the modern era,” the Palestinian official lamented.

He also regretted that the regime had added “systematic and dangerous starvation to its aggression, falsely claiming before the world that it allows 250 [aid] trucks into Gaza daily. In reality, the number of trucks is far fewer.”

Hayya, meanwhile, regretted that “scenes of children torn apart, women screaming over their children, and heart-wrenching destruction have failed to stir enough humanity to stop these crimes.”

He decried the United States for vetoing the United Nations Security Council’s resolutions that are aimed at bringing about a potential ceasefire in the war, saying this indicated Washington’s “partnership in the aggression” and a simultaneous siege that the Israeli regime has been enforcing on Gaza.

Addressing Israeli Prime Minister Benjamin Netanyahu, the official asserted that, despite what the Israeli official is after, Hamas would not hand over the regime’s captives “without [the regime’s] stopping the war.”

He called Netanyahu “the main obstacle” in the way of cessation of the aggression, saying the Israeli premier “blocks any progress for political reasons,” and citing his preventing conclusion of a ceasefire agreement in July.

Hayya also warned that the regime sought to expand the war beyond Gaza, but asserted that its goals are “impossible and will never happen.”

“Today, the enemy exposes its true intentions of extermination and displacement, but it will fail,” he stressed.

“The Palestinian people are resilient and will not surrender, as they believe in their humanitarian and political cause. The enemy and its allies will not succeed in achieving their goals. This steadfast people will endure, and the occupation will not prevail against them.”

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News Network
November 15,2024

Udupi: The Tourism Department is planning a major eco-friendly development initiative for Kamini Island, located near the Blue Flag-certified Padubidri End Point beach, aiming to attract more visitors while maintaining environmental sustainability.

Assistant Director Kumar CU emphasized that, given the island’s proximity to the Blue Flag beach, all development efforts will center around eco-friendly practices. “We are looking to enhance the Kamini River and the island’s surroundings by adding a hanging bridge, nature trails, and eco-friendly food courts offering traditional cuisine. Visitors will also be able to reach the island by pedal boats or kayaking,” he said.

The development project is estimated to cost between Rs 3 crore and Rs 4 crore. Meanwhile, the Blue Flag beach, Padubidri, continues to see a steady flow of visitors. Vijay Shetty, manager of the beach, shared that tenders for food courts and water sports have been awarded to private parties. Recently, three new coracles have been introduced, which are proving to be a hit with visitors. Additionally, three more shelters are expected to be ready by November 20.

Shetty mentioned that the beach can now accommodate between 2,500 and 3,000 visitors daily, although footfall remains lower than other district beaches due to user fees and activity restrictions. “Initially, most visitors were from Mangaluru, but now nearly 40% come from other districts, showing a shift in the visitor demographics,” Shetty noted.

To further boost tourism and promote a healthy lifestyle, a Beach Carnival is set to take place on November 23-24, featuring the National Sea Swimming Championship and a sea marathon in collaboration with the Padubidri JCI, which is celebrating its golden jubilee. Cultural events will be held at the main beach, with some sports events taking place at the Blue Flag beach. Emphasis will be placed on making all activities environmentally friendly.

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