After Pfizer, Serum Institute applies for emergency use authorisation for COVID-19 vaccine
New Delhi, Dec 7: Vaccine major Serum Institute of India (SII) on Monday said it has applied to the Drugs Controller General of India (DCGI) for emergency use authorisation for AstraZeneca-Oxford COVID-19 vaccine in the country.
Earlier, the Indian arm of US pharmaceutical giant Pfizer became the first company to seek a similar approval from India's drug regulator for Pfizer/BioNTech vaccine against COVID-19 in the country, after securing such clearance in the UK and Bahrain.
Pune-based SII has collaborated with AstraZeneca and Oxford University for manufacturing the vaccine and is conducting phase-three clinical trials of the Covishield vaccine in India.
"As promised, before the end of 2020, @SerumInstIndia has applied for emergency use authorisation for the first made-in-India vaccine, COVISHIELD,"
Serum Institute of India (SII) CEO Adar Poonawala said in a tweet.
He further added, "This will save countless lives, and I thank the Government of India and Sri @narendramodi ji for their invaluable support".
According to the Indian Council of Medical Research (ICMR), SII has already manufactured 40 million doses of the vaccine under the at-risk manufacturing and stockpiling license it obtained from the DCGI.
Official sources, citing the SII application, said the firm has stated that data from four clinical studies, two in the UK and one each in Brazil and India, shows that Covishield is highly efficacious against symptomatic and most importantly against severe COVID-19 infections.
According to sources, this vaccine is logistically feasible for distribution in the country's both urban and rural parts as it can be stored at two to eight degrees celsius.
Earlier on November 29, Poonawalla in a virtual press conference had said that the company was in the process of applying in the next two weeks for an emergency use licensure for Covishield.
As promised, before the end of 2020, @SerumInstIndia has applied for emergency use authorisation for the first made-in-India vaccine, COVISHIELD. This will save countless lives, and I thank the Government of India and Sri @narendramodi ji for their invaluable support.
— Adar Poonawalla (@adarpoonawalla) December 7, 2020
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US VP JD Vance says Lebanon not part of ceasefire, calls it ‘misunderstanding’
Budapest/Washington: US Vice President J D Vance has said that Lebanon was never included in the ceasefire understanding with Iran, describing the confusion as a “legitimate misunderstanding”.
Speaking to reporters before departing from Hungary, Vance said, “I think the Iranians thought that the ceasefire included Lebanon and it just didn’t. We never made that promise.”
He stressed that the United States had not included Lebanon in the scope of the ceasefire at any stage.
His remarks come amid continued Israeli strikes in Lebanon, where more than 200 people were reported killed, even as ceasefire talks between Iran and the US move forward.
Vance said Israel had “offered … to check themselves a little bit in Lebanon because they want to make sure that our negotiation is successful”.
He warned that if Iran allows the situation in Lebanon to affect the negotiations, it could derail the talks.
“If Iran wants to let this negotiation fall apart in a conflict where they were getting hammered over Lebanon, which has nothing to do with them and which the United States never once said was part of the ceasefire, that’s ultimately their choice,” he said.
