The DCGI's nod came after the subject expert committee on COVID-19 of the CSDCO last week recommended granting emergency use authorisation to Covovax for the age group of 7 to 11 years.
Elon Musk, who has made a successful USD 44 billion acquisition bid for Twitter, had in the past asked India to reduce import duties to sell Tesla electric cars but the government has insisted on local manufacturing.
Serum Institute of India (SII) Director for Government and Regulatory Affairs Prakash Kumar Singh had written to the Union Health Ministry recently, requesting for Covovax's inclusion in the immunisation drive for children aged 12 to 17 years.
Covovax has already been recommended by the Drugs Controller General of India for children above 12 years of age, but its administration has not been allowed yet.
In February, Director, Government and Regulatory Affairs at Serum Institute of India, Prakash Kumar Singh had sought from DCGI nod to conduct a phase-3, observer-blind, randomized, controlled study to evaluate the safety and immunogenicity of Covovax as a booster dose in adults
Covishield has been one of the main Covid-19 vaccines used in India for inoculation. Around 90% population have got Covishield.
Speaking about the Omicron variant, Poonawalla said, "On the back of enough data, it is safe to say that booster vaccine doses are a proven strategy to get antibodies up to a great extent".
The DCGI office had granted SII permission to manufacture and stock Covovax on May 17. Based on the DCGI's approval, till now, the Pune-based firm has manufactured and stockpiled vaccine doses.
The vaccine maker has cumulatively produced 1.25 billion doses of COVID-19 vaccines so far, a company statement said.
If the DCGI grants regular marketing authorisation, Covishield will be the second vaccine in the world to receive such approval. Pfizer-BioNTech's COVID-19 vaccine has received full US FDA approval for use in individuals 16 years of age and older.
Representatives from seven vaccine makers -- Serum Institute of India, Bharat Biotech, Dr Reddy's Laboratories, Zydus Cadila, Biological E, Gennova Biopharma and Panacea Biotech -- participated in the meeting.
As many as nine centres have been identified across India for this phase, including Bharati Vidyapeeth Medical College Hospital.
The trial would be held across 10 sites and would cover 920 children -- 460 each in the age groups of 12-17 and 2-11 -- according to official sources.
The government thinks that this move is feasible now because there are many vaccines available for the people, apart from Covishield and Covaxin, and also because there is a sufficient amount of vaccines available in the country.
Cyrus Poonawalla on Friday strongly affirmed that mixing two different vaccines of COVID-19 is a very risky decision and it is must be discouraged.
If cocktail vaccines are administered and if the result is not good, then SII may say that another vaccine was not good, vice versa, the other company might say that since you mixed Serum's vaccine, it did not give desired results, Poonawalla said.
He also thanked the government for all the support provided to Serum Institute and said the company is always trying to expand its Covishield production capacity to meet the demand.
The RDIF and Serum Institute of India, the world’s largest vaccine producer, will start production of Sputnik V vaccine in September.
According to information provided to the Drugs Controller General of India (DCGI) by the Pune-based Serum Institute of India, it has sent 45 batches of Covishield, amounting to 10. 80 crore doses, to the Central Drugs Laboratory, Kasauli for release in June so far
“We are now urgently trying to work with AstraZeneca itself as well as SII, the Government of India to restart those shipments so that we can get those second doses into those populations because we are running” to a longer interval “than we would have liked,” a WHO official said.
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