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 7,2024

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The Israeli regime has killed at least 40 people during new airstrikes against eastern Lebanese areas, besides targeting the country’s capital Beirut with fresh acts of aggression.

Lebanon’s health ministry announced the fatalities on Wednesday, saying 53 other people had also been wounded during the aerial attacks that targeted the country’s Bekaa Valley, including the city of Baalbek.

In early Thursday, the regime was also reported to have attacked Beirut’s southern suburbs, including a site adjacent to Rafiq Hariri International Airport.

The attacks came after the regime issued short-notice evacuation orders apparently directed at the residents of the areas, claiming that the areas contained facilities belonging to Lebanon’s Hezbollah resistance movement.

Tel Aviv has been using similar claims on countless occasions since last October, when it markedly intensified its deadly acts of aggression against Lebanon, in order to try to justify the escalation. Hezbollah has, however, invariably refuted the claims.

Also on Wednesday, the United Nations warned in its most recent flash report on the humanitarian crisis caused by the Israeli atrocities targeting Lebanon that the aggression had “reached a critical point.”

The attacks have claimed the lives of more than 3,000 people, which was “58 percent more than the 1,900 fatalities” that were caused by the regime’s 2006 war against Lebanon, the report said.

“Additionally, an estimated 1.3 million people have been displaced, both within Lebanon and into neighboring countries, 33 percent more than the number of people displaced in 2006,” it added.

Women comprised the majority of those who had been rendered homeless within Lebanon as a result of the Israeli attacks, the report noted.

It also regretted that the Israeli attacks had featured 78 assaults on healthcare facilities across the country that had claimed the lives of 130 health workers and injured 111 others.

In response to the aggression, Hezbollah has been staging hundreds of retaliatory strikes against the occupied Palestinian territories and the Israeli forces trying to advance on southern Lebanese areas.

The movement has vowed to sustain its strikes until the regime ends the escalation.

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News Network
November 21,2024

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Prominent NRI community leader SM Syed Khalilur Rehman, fondly known as CA Khalil, passed away in Dubai on Thursday at the age of 86 after a brief illness.

Khalil had been admitted to Aster Hospital in Mankhool on Tuesday after experiencing severe leg weakness. Despite the best efforts of the medical team, he succumbed to a double heart attack that worsened his condition, his son Rais Ahmed confirmed.

The news of his passing has sent waves of grief across communities, particularly in his hometown of Bhatkal, Karnataka, where he was a celebrated figure. Tributes have been pouring in on social media, highlighting his significant contributions to international trade, social service, and education.

A Legacy of Leadership and Service

A chartered accountant by profession, Khalil was a founding member of the Dubai chapter of the Institute of Chartered Accountants of India (ICAI), where he served as chairman from 1987 to 1994. His illustrious career included key leadership roles, such as general manager of Khaleej Times, group executive director of the Ilyas and Mustafa Galadari Group, and vice-chairman of the Jashanmal Group of Companies.

He also chaired Maadhyama Communications and Sahil Online, a web-based news platform, and was a director and trustee of several media companies and charitable organisations in Dubai and India.

A Champion for Education and Philanthropy

Khalil’s impact extended far beyond his professional achievements. As president and general secretary of Anjuman Hami-e-Muslimeen, he played a pivotal role in the development of educational institutions, including schools and colleges in Bhatkal and surrounding areas. His dedication to social upliftment earned him recognition from the Government of Karnataka, which honoured him with a prestigious award for his philanthropic contributions.

A Life Celebrated

The Bhatkal Muslim Khaleej Council (BMKC) recently released a documentary celebrating Khalil’s remarkable life and service to the community—a testament to his enduring legacy.

CA Khalil is survived by his family and countless admirers across the globe. His passing marks the end of an era for Indian expatriates in the UAE and beyond, leaving behind a legacy of leadership, generosity, and commitment to community service.

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News Network
November 19,2024

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