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An employee in PPE removes vials of AstraZeneca's COVISHIELD from a visual inspection machine inside a lab at Serum Institute of India, Pune. (REUTERS)
An employee in PPE removes vials of AstraZeneca's COVISHIELD from a visual inspection machine inside a lab at Serum Institute of India, Pune. (REUTERS)

India's 1st Covid-19 vaccines: DCGI approves Serum, Bharat Biotech vaccines for emergency use

  • The DCGI on Sunday formally announced the approval of Bharat Biotech's Covaxin and the Serum Institute of India's Covishield for 'restricted use' in the country
  • DCGI VG Somani said both the drug firms have submitted data on their trial runs and both have been granted permission

NEW DELHI : The Drugs Controller General of India (DCGI) on Sunday approved the Oxford coronavirus vaccine and Bharat Biotech's Covaxin, making it India's first vaccines against the pandemic.

DCGI VG Somani said 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. It (people may get impotent) is absolute rubbish," VG Somani said.

However, he also said that some side effects like mild fever, pain and allergy are common for every vaccine.

The DCGI addressed a press conference at 11 am today at the National Media Centre regarding the Covid-19 vaccine in India.

The country has been preparing for a Covid-19 vaccine rollout for the last four months.

'Every Indian proud that vaccines approved are Made in India'

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 granting approval to vaccines of Serum Institue of India & Bharat Biotech accelerates the road to 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.

India on Saturday moved a step closer to getting a vaccine against the novel coronavirus as two candidates -- Hyderabad-based Bharat Biotech's Covaxin and the Serum Institute of India's Covishield -- have been recommended by a government-appointed panel to the DCGI for emergency use in the last two days.

As per an official release, the 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 Cadila Healthcare Ltd.

Meanwhile, India recorded 18,177 fresh coronavirus infections today, 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.

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