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
May 6,2024

Mangaluru, May 6: A five-year-old girl from Arendur village of Siddapura taluk of Uttara Kannada district died of Kyasanur Forest Disease (monkey fever) recently.

As her health deteriorated, she was admitted to the KMC Hospital in Mangaluru, where she failed to respond to the treatment and died on Friday night.

It is learned that the KFD is slowly spreading to the newer areas of coastal and malnad areas of Karnataka

According to officials, KFD spreads due to bites of ticks that generally survive on monkeys. This tick bites humans which causes the infection. Humans also contract the disease by coming in contact with cattle bitten by ticks.

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News Network
May 10,2024

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The Supreme Court Friday granted interim bail to Delhi Chief Minister Arvind Kejriwal till June 1 in the excise policy case.

The top court, however, stated that it will be passing a detailed order over the matter soon.

On Thursday, the Enforcement Directorate had opposed the move to grant interim bail to Kejriwal saying that “any special concession” to him will “amount to anathema to the rule of law and equality… thereby creating two separate classes in the country viz. ordinary people, who are bound by the rule of law as well as the laws of the country, and politicians who can seek exemption from the laws”.

The ED had arrested Kejriwal on March 21 in the excise policy case.

“The right to campaign for an election is neither a fundamental right nor a constitutional right and not even a legal right,” the ED said, maintaining that to its knowledge, “no political leader has been granted interim bail for campaigning even though he is not the contesting candidate”.

After the ED filed its affidavit, the AAP, in a press release, said, “The legal team of Delhi Chief Minister and AAP National Convenor, Shri Arvind Kejriwal, has raised strong objection to the affidavit filed by the Enforcement Directorate opposing interim bail in the Supreme Court.”

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News Network
May 10,2024

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A day after National Commission for Women said no woman from Hassan approached the national body to file complaints against Karnataka MP Prajwal Revanna, a new FIR accusing BJP leader Devaraje Gowda of abusing and assaulting a woman has come to light.

The FIR against Gowda was filed by a woman at the Holenarasipura town police station on April 1, after her husband had filed a complaint against the BJP leader on March 30. 

The purported victim's husband has alleged in his plaint that Gowda barged into their home, and threatened the couple while the BJP leader also abused the woman.

Gowda, notably, flagged Prajwal Revanna's case to the saffron party.

Reacting to the allegations levelled against him, the BJP politico posted a video on Facebook where he details how he met the woman and her husband in his office. He also claims that the allegations against him are a plot and false.

It must be noted here that a Special Investigation Team is currently probing the sexual assault cases against Prajwal Revanna who along with his driver Karthik is no longer in the country. A Blue Corner notice is also in place to apprehend the son of H D Revanna who himself is placed under judicial custody till May 14.

In a major twist to the entire case— the woman in the FIR alleged that Devaraje Gowda who apprised BJP of the sex videos involving Prajwal Revanna— has been harassing her for the past 10 months under the guise of helping her sell a property.

The woman also said that she came in contact with Gowda during the process involving the property that she wanted to sell. However, on the pretext of guiding her, the woman alleged that the whistleblower BJP leader physically assaulted and harassed her while Gowda also threatened the couple.

The woman has now sought police protection for herself and family. Further levelling allegations against Gowda in her plaint, she said that the politico had taken her to an isolated place where he assaulted her and threatened to kill the couple.

Former chief minister of Karnataka and Prajwal Revanna's uncle H D Kumaraswamy recently demanded a CBI probe in the Prajwal Revanna matter. However, Home Minister G Parameshwara turned down the demand for the investigation to be handed over to CBI.

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