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
April 28,2024

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Bengaluru: JD(S) leader H D Kumaraswamy on Sunday said he would like to wait for the facts to come out of the investigation into an alleged sex scandal involving his nephew and Hassan MP Prajwal Revanna, but asserted that there is no question of forgiving anyone who has committed a crime as per law.

The former chief minister said he has nothing to do with Prajwal Revanna reportedly leaving the country, and it is the responsibility of the Special Investigation Team (SIT) to get him back if required.

The 33-year-old Prajwal Revanna is the son of former prime minister and JD(S) patriarch H D Deve Gowda's elder son H D Revanna, who is an MLA and former minister.

Some explicit video clips allegedly involving Prajwal Revanna had started making the rounds in Hassan in recent days.

Prajwal Revanna is the BJP-JD(S) alliance's candidate from Hassan, which went to polls on Friday.

Kumaraswamy said, "I have noticed that the chief minister has ordered an SIT probe. Whether it is me or Deve Gowda (his father), we have always conducted ourselves respectfully towards women and have responded positively when anyone came with any sufferings. We have tried to address them."

Speaking to reporters here, he said, "The Hassan related issue that started during elections, let the facts come out through a probe. Whoever it is, who has committed the mistake as per the law of the land...there is no question of forgiving anyone who has committed the mistake. So let the facts come out from the probe, after that I will react."

To a question on Prajwal Revanna going to a foreign country, Kumaraswamy said, "It is not related to me. SIT probe has been ordered, officials have been put to work. If he has gone to a foreign country, getting him back is their responsibility. What should I say, if I'm asked. They (SIT) will get him, don't worry."

Chief Minister Siddaramaiah announced the decision to constitute a SIT to probe the alleged sex scandal involving the MP.

Meanwhile, the police have information that Prajwal has left the country, according to a statement issued by the Chief Minister’s office.

"Prajwal Revanna’s explicit video clips are being circulated in Hassan and it appears prime facie that women were sexually assaulted,' the statement said, adding that the government decided to form an SIT based on a petition by the chief of the Karnataka State Commission for Women.

The Commission's chairperson Dr Nagalakshmi Chaudhary on Thursday wrote to Siddaramaiah and state police chief Alok Mohan, seeking a probe into the videos that are in circulation in Hassan.

Prajwal has through his election agent lodged a complaint with the authorities that the videos are "doctored" and being circulated to tarnish his image ahead of elections.

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News Network
May 4,2024

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Mangaluru, May 4: A tragic incident unfurled last evening in Subrahmanya of Kadaba taluk in Dakshina Kananda, where a young gentleman, who had recently entered the bonds of matrimony a mere ten days hence, met his untimely demise due to a lightning strike.

As twilight descended, a tempestuous thunderstorm, accompanied by billowing rain clouds, cast its shadow over the locale.

Somasundar was diligently engaged in the task of piling up dried nuts in the yard to shield them from the impending deluge, when fate cruelly intervened, subjecting him to the fatal force of a lightning bolt.

Despite the expeditious efforts to convey him to Kadaba Community Hospital subsequent to his sudden indisposition, he tragically succumbed to his injuries. 

Somasundar, who operated a car washing enterprise in proximity to Subrahmanya, is mourned by his mother, sister, and wife.

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News Network
April 29,2024

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In yet another setback to the Congress party amid the ongoing Lok Sabha elections, its candidate from Indore Akshay Kanti Bam withdrew his nomination on Monday, April 29, days before voting.

Interestingly, he had reached the Collector's office with BJP MLA Ramesh Mendola to withdraw his nomination. He also reportedly joined BJP. 

Senior BJP leader and state cabinet minister Kailash Vijayvargiya in a post on X said Bam was welcome to join the BJP.

"Congress Lok Sabha candidate from Indore Akshay Kanti Bam is welcome in the BJP under the leadership of Prime Minister Narendra Modi, party national president J P Nadda, Chief Minister Mohan Yadav and state president VD Sharma," he said in the post.

The Congress had fielded Bam against sitting BJP MP Shankar Lalwani from the Indore Lok Sabha seat, where polling will be held on May 13.

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