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 12,2024

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Mysuru, Nov 12: Zameer Ahmad Khan, the Tourism and Waqf minister of Karnataka, who stirred a controversy by addressing the Union Minister HD Kumaraswamy as ‘Kaala Kumaraswamy’ has tendered apologies for his remarks.

Speaking to reporters in Mysuru on Tuesday, Minister Zameer stated that he will apologise if remarks have hurt JD-S workers.

“We both are very close. Then, in a total of 24 hours, we were together for 14 hours. He used to fondly address me as “kulla” (shorty) and I used to address him as “kariyanna” (blacky, kaalia),” Minister Zameer stated.

“I am not addressing him as ‘kaalia’ for the first time. I have not said something highly derogatory. It is being made as big in the backdrop of elections. With love, he used to call me a shorty and I called him a blacky. If I had caused pain to anyone by my words I apologise,” he said.

He further stated: “Kumaraswamy had said that he didn’t want the votes of the Muslim community. But now they are attempting to purchase Muslim votes. Against this backdrop, I have made the remark.”

Minister for Home G. Parameshwara stated on Tuesday, “Minister Zameer and Kumaraswamy are close friends. Their comments against each other are not significant.”

Zameer Ahmad Khan, the Tourism and Waqf minister of Karnataka stirred a controversy on Monday as he addressed the Union Minister as ‘Kaala Kumaraswamy’.

JD-S on Tuesday demanded a public apology and resignation of Minister for Waqf and Tourism Zameer Ahmad Khan over his ‘racist’ remarks.

“Remember, there is no place here for your divisive policies. You have insulted the people by making ethnic, racist and discriminatory statements. You should apologize to the people of the state and resign,” the JD (S) demanded in the post.

Union Parliamentary Affairs and Minister for Minority Affairs Kiren Rijiju reacted sternly to the racist jibe and stated, “I strongly deplore Congress Minister Zameer Ahmed calling Union Minister and former Chief Minister of Karnataka Kumaraswamy as 'Kaalia Kumaraswamy'.

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News Network
November 19,2024

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