Serum Institute pauses covid 19 vaccine trials in India on DGCI instructions

Agencies
September 10, 2020

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New Delhi, Sept 10: The Serum Institute of India (SII), which was conducting the India trials for the coronavirus vaccine being developed by Oxford University, on Thursday paused the clinical trials of the vaccine in India.

In a statement, the Serum Institute of India said: "We are reviewing the situation and pausing India trials till AstraZeneca restarts the trials. We are following DCGI's instructions and will not be able to comment further on trials."

The declaration by the Pune-based vaccine manufacturer came a day after the Drug Control General of India (DCGI), V.G. Somani, issued a show-cause notice to them asking for an explanation as to why the institute decided to go ahead with the clinical trial of Covid-19 vaccine candidate while doubts about patient safety are yet unclear.

The notice was issued in the wake of an advert incident where one of the participants in the UK reported a suspected severe adverse reaction when administered a booster dose of Covishield, a vaccine candidate developed jointly by pharma giant AstraZeneca and University of Oxford, on Tuesday.

"Whereas, Serum Institute of India Pvt Ltd, Pune, till now has not informed the Central licensing authority regarding pausing the clinical trial carried out by AstraZeneca in other countries and also not submitted casualty analysis of the reported serious adverse event with the investigational vaccine for the continuation of phase 2 and 3 clinical trials of the subject vaccine in the country in light of the safety concerns," the notice by DGCI read.

The DGCI further asked the institute why the authority does not suspend the permission given to the SII for the clinical trials of Covishield.

"In view of the above, I, Dr V G Somani, Drugs Controller General of India and Central Licensing Authority hereby give you an opportunity to show cause as provided under rule 30 of the New Drugs and Clinical Trials Rules, 2019, why the permission granted to you August 2 shall not be suspended till patient safety is established," the notice further said.

SII is the partner of the University of Oxford's Jenner Institute's to conduct the vaccine trials. SII is currently progressing the second and third phase study of the vaccine candidate at 17 trial sites across India.

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News Network
November 21,2024

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The International Criminal Court (ICC) has issued arrest warrants for Israeli prime minister Benjamin Netanyahu and his former minister of military affairs Yoav Gallant over war crimes against Palestinians in the Gaza Strip.

The court’s Pre-Trial Chamber I issued warrants of arrest for Netanyahu and Gallant "for crimes against humanity and war crimes committed from at least 8 October 2023 until at least 20 May 2024, the day the Prosecution filed the applications for warrants of arrest”, it confirmed in a statement Thursday.

It is the first instance in the court's 22-year history it has issued arrest warrants for Western-allied senior officials.

In its statement, the ICC's Pre-Trial Chamber I, a panel of three judges, said it has rejected appeals by Israel challenging its jurisdiction. 

The chamber said it has decided to release the arrest warrants because "conduct similar to that addressed in the warrant of arrest appears to be ongoing", referring to Israel's ongoing onslaught on Gaza.

Netanyahu and Gallant, it said, “each bear criminal responsibility” for “the war crime of starvation as a method of warfare; and the crimes against humanity of murder, persecution, and other inhumane acts,” as well as “intentionally directing an attack against the civilian population.”

All 124 states that signed the Rome Statute, the treaty that established the court, are now under an obligation to arrest the wanted individuals and hand them over to the ICC in the Hague. 

The court relies on the cooperation of member states to arrest and surrender suspects. The Netherlands' foreign minister quickly said his country was prepared to enforce the warrants while 93 nations earlier reiterated their support for the ICC.

Triestino Mariniello, a lawyer representing Palestinian victims at the ICC, called the warrants "a historic decision".

He noted that the court had endured "pressure and threats of sanctions" from the US government, but acted nonetheless.

As expected, the Tel Aviv regime rejected the rulings, with its security minister Itamar Ben Gvir calling the warrants “anti-Semitic through and through.”

The ICC said Israel’s acceptance of the court’s jurisdiction was not required.

Israel and its major ally, the United States, are not members of the court. 

Israel unleashed its bloody Gaza onslaught on October 7, 2023. So far, it has killed at least 43,985 Palestinians, mostly women and children, and injured 104,092 others, according to the Gaza Health Ministry.

Israel faces an ongoing South Africa-led genocide case at the International Court of Justice (ICJ).

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News Network
November 21,2024

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Shares of Adani Group companies lost about $28 billion in market value in morning trade on Thursday after US prosecutors charged the billionaire chairman of the Indian conglomerate in an alleged bribery and fraud scheme.

Gautam Adani's flagship company Adani Enterprises tumbled 23 per cent, while Adani Ports, Adani Total Gas, Adani Green, Adani Power, Adani Wilmar and Adani Energy Solutions, ACC , Ambuja Cements and NDTV fell between 20 per cent and 90 per cent.

Adani group's 10 listed stocks had a total market capitalisation of about $141 billion at 0534 GMT, compared to $169.08 billion on Tuesday.

US authorities said Adani and seven other defendants, including his nephew Sagar Adani, agreed to pay about $265 million in bribes to Indian government officials to obtain contracts expected to yield $2 billion of profit over 20 years, and develop India's largest solar power plant project.

Adani Green in a statement on Thursday said the US Justice Department had issued a criminal indictment against board members Gautam Adani and Sagar Adani and the Securities and Exchange Commission had issued a civil complaint against them.

The US Justice Department also included Adani Green board member Vneet Jaain in the criminal indictment, it said.

Adani Green's units had decided not to proceed with the proposed US dollar denominated bond offerings due to developments, it added.

"Investors will shy away from Adani Group stocks ... and that's what this sharp selling is signifying," said Saurabh Jain, assistant vice president of retail equities research at SMC Global Securities.

"This could hurt the credibility of the group and maybe borrowing costs will rise," he said.

The indictment comes nearly two years after US shortseller Hindenburg Research alleged that Adani had improperly used tax havens and was involved in stock manipulation, allegations the conglomerate denied.

Also in early Asian trading on Thursday, Adani dollar bonds slumped, with prices down 3c-5c on bonds for Adani Ports and Special Economic Zone. The falls were the largest since the Adani Group came under a short-seller attack in February 2023.

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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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