Home » DCGI approves Serum, Bharat Biotech vaccines for emergency use

DCGI approves Serum, Bharat Biotech vaccines for emergency use

by Raju Vernekar
0 comment 3 minutes read

By Raju Vernekar
New Delhi, Jan. 3:

Eleven months after the first case of deadly COVID-19 was detected in India, the Drugs Controller General of India (DCGI) V G Somani, on Sunday approved Serum Institute of India’s “Covishield” and 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. 
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. 
The DCGI addressed a press conference on Sunday at the National Media Centre regarding the Covax in India. The country has been preparing for a Corona virus vaccine rollout for the last four months.  
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 SII and 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. 
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 Cadila Healthcare Ltd. 
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.   
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 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. 

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