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DCGI Approves Serum, Bharat Biotech Vaccines For Emergency Use

India has been preparing for a Covax rollout for the last four months

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Raju Vernekar
Raju Vernekar
Raju Vermekar is a senior Mumbai-based journalist who have worked with many daily newspapers. Raju contributes on versatile topics.

INDIA. Mumbai: Eleven months after the first case of deadly COVID-19 detected in India, Drugs Controller General of India (DCGI) V G Somani, on Sunday, 03 January 2021 approved the Pune-based Serum Institute of India’s “Covishield” and Hyderabad-based Bharat Biotech’s “Covaxin” ( India’s first vaccines against the pandemic), for emergency use paving the way for their roll-out and administration to millions.

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Both the drug firms have submitted data on their trial runs and both have been granted permission for “restricted use”. The overall efficacy of the Oxford-AstraZeneca COVID-19 vaccine was 70.42%, while Bharat Biotech’s Covaxin was “safe and provides a robust immune response”, VG Somani said.

“We’ll never approve anything if there is slightest of safety concern. The vaccines are 100% safe. Some side effects like mild fever, pain, and allergy are common for every vaccine. To say that the vaccines will make people impotent is absolute rubbish,” VG Somani said, while addressing media at the National Media Centre regarding the Covax in India. The country has been preparing for a Coronavirus vaccine rollout for the last four months.

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PM praises scientific community

After two vaccines received emergency approval, Prime Minister Narendra Modi congratulated the hardworking scientists and innovators in India. “A decisive turning point to strengthen a spirited fight! DCGI approving vaccines of Serum Institute of India and Bharat Biotech accelerate the road to a healthier & COVID-free nation. Congratulations India. Congratulations to our hardworking scientists & innovators,” tweeted PM Modi.

In a series of tweets, PM Modi wrote, “It would make every Indian proud that the two vaccines that have been given emergency use approval are made in India! This shows the eagerness of our scientific community to fulfil the dream of an Aatmanirbhar Bharat, at the root of which is care and compassion. We reiterate our gratitude to doctors, medical staff, scientists, police personnel, sanitation workers, and all Corona warriors for the outstanding work done, that too in adverse circumstances. We will remain eternally grateful to them for saving many lives,” wrote the PM.

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The DCGI’s Subject Expert Committee (SEC) met on Friday and Saturday and made its recommendations in respect of the accelerated approval process request of the SII, Bharat Biotech International Ltd as well as about phase-III trials of Ahmedabad based Cadila Healthcare Ltd(Zydus Cadila).

Meanwhile, India recorded 18,177 fresh coronavirus infections on Sunday, taking the country’s tally to 1,03,23,965, including 2,47,220 active cases. The death toll after 217 new fatalities stands at 1,49,435. 20,923 new recoveries pushed the total number of recoveries to 99,27,310.  

UK-variant of the virus isolated

In another development, the Indian Council of Medical Research (ICMR) said in a tweet on Saturday that India has successfully isolated and cultured the UK-variant of Sars-CoV-2, the virus that causes the coronavirus disease (Covid-19).

“UK-variant of the virus, with all signature changes, is now successfully isolated and cultured at the National Institute of Virology (NIV) from the clinical specimens collected from UK-returnees,” the country’s apex medical body wrote on Twitter. It said that Sars-CoV-2, the virus causing Covid-19, was being tracked through the countrywide network of ICMR-laboratories since the early days of the epidemic in India. No country has yet reported successful isolation and culture of the UK variant, according to ICMR. Vero cell lines were used by the scientists of ICMR-NIV to culture the UK-variant of the virus, it added.

India has reported 29 cases of the new coronavirus variant, which is spreading rapidly around Britain and other countries, within five days of tracing its first such infection. The new United Kingdom variant genome of Sars-CoV-2 – B.1.1.7, which is much more infectious, has prompted comprehensive contact tracing for co-travelers, family members, and others of those who have traveled to the UK in the last 38 days.

Author

  • Raju Vernekar

    Raju Vermekar is a senior Mumbai-based journalist who have worked with many daily newspapers. Raju contributes on versatile topics.

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