Medic regulator chief press conference today, approval of Covid-19 vaccines is likely


The head of India’s drug regulator will deliver a press conference on Sunday, a day after his experts recommended allowing the emergency use in the country of the Oxford-AstraZeneca and Bharat Biotech vaccines against the coronavirus disease ( Covid-19), according to reports. . The Comptroller General of Drugs of India (DCGI) will speak at 11am and the watchdog is reportedly able to formally announce the approval of these two vaccines.

The development comes after the Central Drugs Standard Control Organization (CDSCO) committee of subject matter experts (SEC) recommended the Oxford-AstraZeneca vaccine, which is being manufactured by the Serum Institute of India (SII) as Covishield, for emergency use and Covaxin for restricted use. use. Covaxin is the indigenous vaccine being developed by Bharat Biotech in collaboration with the Indian Council for Medical Research (ICMR).

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The SEC’s recommendations have been sent to DCGI VG Somani, who heads the Central Drug Control and Standards Organization (CDSCO). “The approval is confirmed. Now it is a mere formality for the national drug controller to issue an order, “said a senior health ministry official, who asked not to be identified.

The country’s top drug regulator had indicated earlier this week that India is likely to receive a Covid-19 vaccine in the New Year. “We will have a Happy New Year with something in hand, that’s all I can hint at,” VG Somani, DCGI, said Thursday.

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If DCGI accepts its go-ahead, India will be among a handful of countries, including the US and the UK, that have started vaccinating. Both the US and the UK have also approved two vaccines, but in their case all candidates have completed the required scientific process.

Union Broadcasting and Information Minister Prakash Javadekar said on Saturday that India is perhaps the only country where four Covid-19 vaccines are being prepared. “One was approved yesterday for emergency use, Serum’s Covishield,” he said.

Javadekar had previously told reporters that two other vaccines were waiting to be approved: ZyCoV-D from Zydus Cadila and Sputnik V from Russia, both in testing in India. Six Covid-19 vaccines are undergoing clinical trials in India, including pioneering Covishield and Covaxin. There are also ZyCOV-D, which is being developed by Cadila Healthcare Ltd in Ahmedabad in collaboration with the Center’s biotechnology department, and NVX-CoV2373, which is being developed by the Serum Institute in collaboration with Novavax. There are two other vaccines, one manufactured by Biological E Ltd, Hyderabad, in collaboration with MIT, USA, and the other developed by Gennova Biopharmaceuticals Ltd, based in Pune, in collaboration with HDT, USA.

Bharat Biotech International Ltd is developing another vaccine in collaboration with Thomas Jefferson University, USA, which is in the preclinical stages. Dr. Reddy’s lab is also conducting the Russian Sputnik V test.

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Covishield of IBS, which is based on an adenovirus vector, has shown an efficacy rate of 62% in trials conducted in the UK and Brazil. The Bharat Biotech vaccine is based on an inactivated virus platform, one of the oldest known methods of developing an inoculation. This technique has historically been used for several other diseases, including hepatitis A, influenza, polio, and rabies.

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All Union states and territories carried out mock inoculation in a test on Saturday before the launch, as India is also preparing to carry out the world’s largest vaccination program. Union Health Minister Harsh Vardhan said on Saturday that injections given in the first phase of India’s inoculation campaign will be free. The government aims to vaccinate 300 million people in the high-risk category of the population by July-August in the first phase.

India reported 19,078 new Covid-19 cases and 224 related deaths in the past 24 hours, according to the Union’s Ministry of Health and Family Welfare on Saturday, bringing the count of the second most affected country to more than 10.3 millions.

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