The Drugs Controller General of India (DCGI) on January 3 granted restricted emergency use authorisation for the Serum Institute of India (SII)’s ‘Covishield’ and Bharat Biotech’s ‘Covaxin’ vaccines against COVID-19, the disease caused by the novel coronavirus.
DCGI Dr. VG Somani said that clinical trials will continue. Both vaccines would be administered in two doses and need to be stored at 2-8 degrees Celsius.
The ‘Covishield’ vaccine, developed by University of Oxford and pharmaceutical giant AstraZeneca, is being produced in the country by the Serum Institute. Bharat Biotech has developed ‘Covaxin’ – India’s first indigenous vaccine against COVID-19.
This came a day after the COVID-19 Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) reportedly recommended grating emergency use authorisation for the vaccine developed by Bharat Biotech. On January 1, the SEC had given a similar conditional use recommendation for the Serum Institute of India (SII)'s vaccine. Both recommendations were "subject to certain regulatory conditions".
The expert committee had also recommended speeding up the process of considering indigenous COVID-19 vaccine candidates being developed by SII, Bharat Biotech and Cadilla Healthcare.
The DCGI also granted permission to Cadila Healthcare for conducting phase-III clinical trials of their COVID-19 vaccine candidate.
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In a series of tweets, Prime Minister Narendra Modi congratulated Serum Institute and Bharat Biotech for getting the requisite approvals and said the decision will "accelerate the road to a healthier and COVID-free nation". "Congratulations to our hardworking scientists and innovators," PM Modi said.
"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," PM Modi said in a another tweet.
"Happy new year, everyone! All the risks @SerumInstIndia took with stockpiling the vaccine, have finally paid off. COVISHIELD, India's first COVID-19 vaccine is approved, safe, effective and ready to roll-out in the coming weeks," Adar Poonawalla, CEO and owner of Serum Institute, said in a tweet.
“The approval of Covaxin for emergency use is a giant leap for innovation and novel product development in India. It is a proud moment for the nation and a great milestone in India’s scientific capability, a kickstart to the innovation ecosystem in India," Dr. Krishna Ella, Bharat Biotech's Chairman and Managing Director said.
"While this vaccine addresses an unmet medical need during this pandemic, our goal is to provide global access to populations that need it the most. Covaxin has generated excellent safety data with robust immune responses to multiple viral proteins that persist,” Dr. Ella added.
The restricted use approval paves the way for Indian authorities to start vaccinating the masses. The government has planned vaccination of 25-30 crore people by July.
Healthcare and frontline workers will be given priority. More than 70 lakh healthcare workers have already been registered on the purpose-built Co-WIN platform. Union Health Minister said that the COVID-19 vaccine will be provided free of cost to most prioritised beneficiaries in the first phase of the vaccination exercise.
The dry run for this exercise was carried out in four states on December 28, 2020. Another nationwide mock drill was conducted across all states and Union Territories on January 2.
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SII, Bharat Biotech and Pfizer had applied to the DCGI seeking emergency use authorisation for their COVID-19 vaccine candidates. Since late December, the SEC was deliberating and analysing additional data and information submitted by SII and Bharat Biotech.
As of January 3, India had reported more than 1.03 crore confirmed COVID-19 cases. The death toll from the outbreak in the country stood at 1.49 lakh. While more than 99.27 lakh patients had recovered, 2.49 lakh cases remained ‘active’. Globally, more than 8.4 crore individuals have been infected by the virus and over 18.3 lakh people have died so far.
A speedy rollout of vaccines is being seen as the best way to curb the spread of COVID-19 and restore normalcy in the pandemic-hit global economy. As many as 50 countries, including the United States and the United Kingdom, have already granted emergency use authorisation to multiple COVID-19 vaccines and have started vaccinating high-risk groups.
PM Modi said on December 30, 2020 that people should not let their guard down and strictly abide by safety protocols even after vaccination. “I used to say 'jab tak davai nahi, dhilai nahi (no carelessness until we have a medicine)', but now our mantra for 2021 should be: ‘davai bhi, kadaai bhi’ (yes to medicine, yes to caution),” PM Modi said.
The prime minster also said that preparations for the vaccination programme in India were in final stages and added that people will be given doses of vaccines manufactured in the country.
Serum Institute has already stockpiled 7.5 crore doses of Covishield and will be increasing it to 10 crore units by the first week of January.
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