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Coronavirus News LIVE Updates: Drug Controller Likely to Make Decision on Emergency Use of Pfizer, AstraZeneca’s Vaccines in 2 Weeks

An employee in PPE removes vials of AstraZeneca's COVISHIELD, COVID-19 vaccine from a visual inspection machine inside a lab at Serum Institute of India, in Pune. (Image: Reuters)

An employee in PPE removes vials of AstraZeneca's COVISHIELD, COVID-19 vaccine from a visual inspection machine inside a lab at Serum Institute of India, in Pune. (Image: Reuters)

Coronavirus News LIVE Updates: The internal review of applications seeking emergency use authorisation for Covid-19 vaccines filed by Serum Institute of India and US pharmaceutical giant Pfizer is under process at Drugs Controller General of India (DCGI). The drug regulator is likely to take a call on granting permission for the vaccines in next 2 weeks.

Coronavirus News LIVE Updates: The internal review of applications seeking emergency use authorisation for Covid-19 vaccines filed by Serum Institute of India and US pharmaceutical giant Pfizer is under process at Drugs Controller General of India (DCGI). The drug regulator is likely to take a call on granting permission for the vaccines in next 2 weeks, CNBC-TV18 reported. Earlier in the day, a government official said India is considering reviewing Pfizer Inc and AstraZeneca's vaccines for emergency use on an accelerated basis. "We are in the process of reviewing. It is an accelerated reviewing process, which is there for Serum too," the government official said. "All applications are accelerated. It is the need of the hour." The Serum Institute of India on Sunday became the first indigenous company to apply to the Drugs Controller General of India (DCGI) seeking emergency use authorisation for the Oxford Covid-19 vaccine in the country citing unmet medical needs due to the pandemic and in the interest of the public at large, official sources said. A day earlier, the Indian arm of US pharmaceutical giant Pfizer became the first to seek a similar approval from India's drug regulator for its own Covid-19 vaccine in the country, after securing such clearance in the UK and Bahrain.

The phase-three clinical trial of the Oxford Covid-19 vaccine, Covishield, is being conducted by the Pune-based Serum Institute of India on Sunday (SII), co-sponsored by Indian Council of Medical Research (ICMR), in various parts of the country in addition to clinical studies being carried out by Oxford-AstraZeneca in the UK and Brazil. Based on phase two and three clinical trial results, the SII with the help of the ICMR will pursue early availability of the vaccine for India, the country's apex health research body had said last month.

Here are the latest updates on coronavirus:

• Prime Minister Narendra Modi on Monday said that the country will not have to wait too long for the coronavirus vaccine even as he cautioned people that there should be no laxity as far as prevention of the infection is concerned. He was speaking while inaugurating the construction of the Agra Metro project via video conferencing.

Chinese vaccine company Sinovac announced Monday that it is planning to complete a new facility to double its annual vaccine production capacity to 600 million doses by the end of the year, while also securing a $500 million investment in a boost to its COVID-19 vaccine development efforts.

• According to the ICMR, the 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. The results are in line with other anti-coronavirus vaccines and because of the huge disease burden, Covishield is predicted to alleviate substantial COVID-19 mortality and morbidity, the firm is learnt to have said.

• Donald Trump said Sunday his personal lawyer Rudy Giuliani has tested positive for Covid-19, the latest member of the president's inner circle -- where mask wearing is rare -- to contract the disease. Giuliani's diagnosis comes after he has been crisscrossing the country, leading the president's defiant -- and unsuccessful -- effort to undo Joe Biden's victory in the November 3 presidential election.

• A gauge of Asian shares hit a record peak on Monday on hopes of a much-needed U.S. stimulus package before year-end just as coronavirus vaccines roll out, while oil prices hovered near their highest since March. Japan's Nikkei added 0.1% while Australian shares climbed 0.8%.

• China's Sinovac Biotech has secured $515 million in funding from a local firm to double production capacity of its coronavirus vaccine, the companies said on Monday, as it expects efficacy data of its experimental shot this month. The investment deal also comes as Sinovac expands supply deals and trials of its experimental Covid-19 vaccine CoronaVac with more countries following positive results from early to mid-stage clinical trials.

• With a COVID-19 vaccine perhaps just days away in the U.S., most of California headed into another lockdown Sunday because of the surging outbreak and top health officials warned Americans that this is no time to let their guard down. “The vaccine’s critical,” Dr. Deborah Birx, the White House coronavirus response coordinator, said on NBC's “Meet the Press.” “But it’s not going to save us from this current surge. Only we can save us from this current surge.”