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 17,2024

Mangaluru: District-in-Charge Minister and Minister for Health and Family Welfare, Dinesh Gundu Rao, announced that a day-care chemotherapy centre will soon be established at District Wenlock Hospital. Speaking to mediapersons after reviewing the activities at Wenlock and Government Lady Goschen Hospital, he shared the government’s plans to enhance healthcare services in the region.

Key Initiatives Announced

•    Day-Care Chemotherapy Centre:

  • Ten beds will be reserved for cancer patients.
  • The government will collaborate with Yenepoya Hospital to provide chemotherapy treatments.
  • All required facilities for the centre are already in place, awaiting inauguration by the Chief Minister.

•    Wenlock Hospital Facelift:

  • Critical Care Block: To be built at a cost of ₹24 crore.
  • Integrated Public Health (IPH) Lab: Planned with a budget of ₹1 crore.
  • New OPD Block: As per a 2017 agreement, KMC Hospital will take up construction. Discussions with KMC management are underway.

•    Additional Requirements:

  • A new mortuary and post-mortem building.
  • Paramedical college building.
  • Modern kitchen.
  • Bridge connecting two buildings within the hospital.

•    Total facelift cost: ₹6 crore to ₹10 crore, utilizing funds from the Department of Health and Family Welfare and CSR contributions.

•    Timeline:
By December or January, priority works will be finalized. The superintendents of Wenlock and Lady Goschen Hospitals are scheduled to visit Bengaluru next week to discuss these projects.

•    MRI Fee Allegations:
The minister assured that allegations of patients being charged for MRI scans at Wenlock Hospital will be resolved at the earliest.
These measures aim to improve healthcare accessibility and infrastructure, positioning Wenlock Hospital as a state-of-the-art facility in the region.

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News Network
November 12,2024

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The Palestinian Hamas resistance movement says its fighters have killed at least 20 Israeli soldiers in northern parts of the besieged Gaza Strip in just two days, in retaliation for the occupying regime’s genocidal war on the Palestinian territory.

In a statement on Monday evening, Hamas said that fighters of its military wing, al-Qassam Brigades, “killed at least five occupation soldiers” in northern parts of the coastal territory earlier in the day.

It added that Hamas fighters also killed 15 Israeli soldiers in the war-ravaged region on Sunday.

The resistance movement’s “qualitative operation … confirms once again the failure of the criminal Zionist entity to suppress and eradicate the Palestinian resistance, which continues to direct qualitative strikes against its terrorist soldiers,” Hamas further said on its Telegram channel.

Palestinians have increased their resistance operations in the face of intensified Israeli aggression in northern Gaza that has claimed the lives of more than 1,000 over the past weeks.

“Our valiant resistance is waging a war of attrition with the criminal enemy, inflicting daily losses on its soldiers and vehicles, and all of [Israeli prime minister Benjamin] Netanyahu’s bets and dreams of achieving any of his goals are failing,” the Gaza-based resistance movement added.

Hamas also vowed that Israel’s ongoing crimes and aggression against Gaza would be met with increased resistance and painful strikes, which will continue until the aggression against Palestinians ends and the regime fully withdraws from the blockaded territory.

As the war in Gaza enters its 14th month, the Health Ministry reports that Israeli attacks have killed at least 43,603 Palestinians and wounded 102,929 others.

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