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 12,2024

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Bengaluru, Apr 12: The two men who allegedly plotted and executed the blast that rocked Rameshwaram Cafe in Bengaluru last month have been arrested from Kanthi in Bengal's East Midnapore district, the National Investigation Agency said Friday morning. 

Mussavir Hussain Shazeb and Abdul Matheen Taha were caught after a joint operation by central intelligence agencies and police from Bengal, Karnataka, Telangana, and Kerala, and are en route to Kolkata, the anti-terror agency said in a statement.

The available evidence indicates Shazeb planted the explosive device, placed inside a backpack, at the popular eatery. Taha was responsible for planning the attack and for their disappearance.

These are the second and third arrests in this case; last month Muzammil Shareef, who extended logistical support to the Shazeb and Taha, was taken into custody.

Residents of Karnataka's Shivamogga district, Shazeb and Taha were traced to Kanthi after officials conducted searches at 18 locations across Karnataka, Tamil Nadu, and even Uttar Pradesh.

The blast at Bengaluru's Rameshwaram Cafe on March 1 injured 10 people, customers and staff.

Fortunately there were no deaths; the bag containing the explosives was placed in a relatively less crowded area and against a large pillar that absorbed the brunt of the explosion.

After the blast, the NIA released photos and videos of the accused, as seen on CCTV cameras across Bengaluru. In one such clip, the accused - wearing a face mask - was seen boarding a bus.

The agency had declared a reward of ₹ 10 lakh for information leading to the arrest of each accused. The agency had also questioned their acquaintances, including college and school friends.

The Rameshwaram Cafe, which suffered extensive damage after the blast, reopened eight days later, with enhanced security measures including metal detectors.

BJP’s reaction

The Karnataka BJP on Friday attacked the Siddaramaiah government after the arrest of two men by the NIA in the Bengaluru cafe blast case, saying that the terrorists were 'brothers' of the Congress.

Taking to social media, Karnataka BJP stated, “National Investigation Agency (NIA) detains ‘Brothers’ of Congress in Rameshwaram Blast case. Ever since Jihadi Tipu Sultan’s admirers came to power in Karnataka, terrorists have got a free ride.”

“Chief Minister Siddaramaiah’s ‘Ease of Doing Terror’ Policies have prompted ISIS to now set up its shop in Karnataka. The only guarantee that CM Siddaramaiah has fulfilled is converting prosperous Karnataka into a terror hub,” the BJP stated.

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News Network
April 11,2024

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The head of the political bureau of Hamas says Israel’s assassination of his children will not make the Palestinian resistance group back down on its goals and demands in the latest round of talks aimed at reaching a truce in the Gaza war.

Ismail Haniyeh made the remarks in a phone interview with Qatar-based Al Jazeera TV network on Wednesday night, after an Israeli airstrike killed three of his sons — Hazem, Amir and Mohammad — and four grandchildren in the al-Shati refugee camp in the northern Gaza Strip. 

“Our demands are clear and specific and we will not make concessions on them. The enemy will be delusional if it thinks that targeting my sons, at the climax of the negotiations and before the movement sends its response, will push Hamas to change its position,” he said.

The Israeli military and the regime’s so-called internal security service, Shin Bet, confirmed killing Haniyeh’s sons, who were visiting relatives on the occasion of Eid al-Fitr before their vehicle was struck.

The assassination came at a time when Hamas was preparing a response to Israel’s proposal for a Gaza ceasefire delivered through mediators during the negotiations in Cairo.

Also in his remarks, Haniyeh said killing his sons would only make Hamas “more steadfast in our principles and adherence to our land.”

The resistance group, he added, would “not surrender, and […] not compromise […] no matter how great our sacrifices are.”

The Hamas leader also noted that around 60 members of his family, including nieces and nephews, have been martyred during the Gaza onslaught. 

“All our people and all the families of Gaza have paid a heavy price in blood, and I am one of them,” he said.

Haniyeh further decried Israel’s brutality in Gaza, saying the regime is conducting a war of ethnic cleansing and genocide on the besieged territory.

“There is no doubt that this criminal enemy is driven by the spirit of revenge and the spirit of murder and bloodshed, and it does not observe any standards or laws,” he stressed.

Erdogan extends condolences to Haniyeh

Türkiye’s President Recep Tayyip Erdogan has extended his condolences to Haniyeh over the deaths of several of his family members, the Turkish Communications Directorate said.

During the phone call on Wednesday, Erdogan said that Israel will be held accountable before the law for its crimes against humanity.

In addition, Turkish Vice President Cevdet Yilmaz condemned the attack and conveyed his condolences to Haniyeh.

”The Israeli administration will eventually be held accountable for these inhumane attacks under international law,” Yilmaz said on X.

Israel waged its bloody US-backed war on Gaza on October 7 after Hamas carried out its historic operation against the usurping entity in retaliation for the regime's intensified atrocities against the Palestinian people.

So far, the occupying regime has killed at least 33,482 Palestinians, mostly women and children, and injured 76,049 others.

Ansarullah’s reaction

Meanwhile, the Yemeni Ansarullah resistance group extended its condolences to Haniyeh.

“These great sacrifices … indeed strengthen the steadfastness of Palestinian people in the face of Israeli arrogance,” Ansarullah spokesman Mohammed Abdul-Salam stated.
On the threatened invasion of the city of Rafah in southern Gaza, Haniyeh said, “We will not submit to the occupying regime’s intimidation, as those who surrender will not be spared.”

Shati is the third-largest refugee camp among the eight in the Gaza Strip, and also one of its most crowded, with thousands of people living in an area of less than half a square kilometer.

Ismail Haniyeh, who now lives in Qatar, is originally from Shati camp.

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News Network
April 14,2024

Qatar and Kuwait have banned any use of their airspace and air bases for attacks against Iran amid heightened tensions between Iran and the Israeli regime following an Israeli attack early this month on an Iranian diplomatic mission in Syria.

Reports on Saturday indicated that both Qatar and Kuwait had issued directives to the United States stressing that the US military will not be allowed to use air bases in the two countries for carrying out any potential airstrikes on Iran.

Qatar and Kuwait have also indicated that their airspace will not be available for any military action against Iran.

The US has military aircraft at the Ali Al Salem Air Base and Ahmed Al Jaber Air Base in Kuwait. The Al Udeid Air Base in Qatar is also the largest US air base in the West Asia region.

The directives issued by Iran’s two Arab neighbors come amid reports showing that Iran is preparing to respond to an Israeli airstrike that killed two of its senior military commanders in its consulate in the Syrian capital Damascus on April 1.

Washington has urged Iran to deescalate while saying that it will defend Israel in case it is attacked.

Iran, which has no direct relations with the US, has called on regional Arab countries to advise the US not to interfere if Israel is attacked.

Countries have been wary of a major confrontation in the region more than six months into an Israeli onslaught on the Gaza Strip.

Reports show they have already limited the ability of the US to use their airspace and air bases for attacks on resistance groups that are allied with Iran and have been attacking Israeli and US interests in the region since the start of the Israeli aggression on Gaza.

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