Bharat Biotech seeks emergency use authorisation for indigenously developed COVID-19 vaccine Covaxin
New Delhi, Dec 7: After Pfizer and Serum Institute, Hyderabad-based pharmaceutical firm Bharat Biotech on Monday applied to the central drug regulator seeking emergency use authorisation for its COVID-19 vaccine Covaxin, official sources said.
Covaxin is being indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
The Hyderabad-based firm is conducting phase-3 clinical trial of its vaccine in around 25 places, including Delhi, Mumbai, Patna and Lucknow.
The firm, while applying for the phase-3 trial, had stated that the vaccine was well-tolerated in all dose groups and no serious adverse events have been reported. The most common adverse event was transient pain at the injection site, a source said.
The Drugs Controller General of India (DCGI) had on October 23 granted permission to the firm for conducting phase-3 clinical trial of Covaxin after assessing the safety and immunogenicity data of phase 1 and 2 trials.
An expert committee of the Central Drugs Standard Control Organisation (CDSCO) will meet on Wednesday to review applications of Pfizer, Serum Institute of India and Bharat Biotech seeking emergency use authorisation for their COVID-19 vaccine candidates.
At an all-party meeting on December 4, Prime Minister Narendra Modi had expressed hope that a COVID-19 vaccine may be ready in a few weeks.
That evening, the Indian arm of US pharmaceutical giant Pfizer had sought approval for its vaccine from the central drug regulator, after the firm secured such clearance in the UK and Bahrain.
The Serum Institute sought the nod for the Oxford COVID-19 vaccine, Covishield, on December 6.
"DCGI has already started processing the applications. The subject expert committee on COVID-19 at CDSCO will deliberate on the applications by Pfizer, Serum Institute of India and Bharat Biotech seeking emergency use authorisation for their COVID-19 vaccines on December 9," a source said.
Let the Truth be known. If you read VB and like VB, please be a VB Supporter and Help us deliver the Truth to one and all.
Trump sues BBC for USD 10 billion, alleges defamation over edited Jan 6 speech
Washington (AP): President Donald Trump filed a lawsuit Monday seeking USD 10 billion in damages from the BBC, accusing the British broadcaster of defamation as well as deceptive and unfair trade practices.
The 33-page lawsuit accuses the BBC of broadcasting a “false, defamatory, deceptive, disparaging, inflammatory, and malicious depiction of President Trump,” calling it “a brazen attempt to interfere in and influence” the 2024 US presidential election.
It accused the BBC of “splicing together two entirely separate parts of President Trump's speech on January 6, 2021” in order to ”intentionally misrepresent the meaning of what President Trump said.”
The lawsuit, filed in a Florida court, seeks USD 5 billion in damages for defamation and USD 5 billion for unfair trade practices.
The BBC did not immediately respond to a request for comment from The Associated Press.
The broadcaster apologised last month to Trump over the edit of the Jan. 6 speech. But the publicly funded BBC rejected claims it had defamed him, after Trump threatened legal action.
BBC chairman Samir Shah had called it an “error of judgment,” which triggered the resignations of the BBC's top executive and its head of news.
The speech took place before some of Trump's supporters stormed the US Capitol as Congress was poised to certify President-elect Joe Biden's victory in the 2020 election that Trump falsely alleged was stolen from him.
The BBC had broadcast the hourlong documentary — titled “Trump: A Second Chance?” — days before the 2024 US presidential election. It spliced together three quotes from two sections of the 2021 speech, delivered almost an hour apart, into what appeared to be one quote in which Trump urged supporters to march with him and “fight like hell.” Among the parts cut out was a section where Trump said he wanted supporters to demonstrate peacefully.
Trump said earlier Monday that he was suing the BBC “for putting words in my mouth.”
“They actually put terrible words in my mouth having to do with Jan. 6 that I didn't say, and they're beautiful words that I said, right?" the president said unprompted during an appearance in the Oval Office. "They're beautiful words, talking about patriotism and all of the good things that I said. They didn't say that, but they used terrible words.”
The president's lawsuit was filed in Florida. Deadlines to bring the case in British courts expired more than a year ago.
Legal experts have brought up potential challenges to a case in the US, given that the documentary was not shown in the country.
The lawsuit alleges that people in the US can watch the BBC's original content, including the “Panorama” series, which includes the documentary, by using the subscription streaming platform BritBox or a virtual private network service.
The 103-year-old BBC is a national institution funded through an annual license fee of 174.50 pounds (USD 230) paid by every household that watches live TV or BBC content. Bound by the terms of its charter to be impartial, it typically faces especially intense scrutiny and criticism from both conservatives and liberals.
