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.
On the need for vaccinating kids in the 5-11 age bracket, he said, "My point is we can't put a price tag on the life of a person. Also if an additional dose of vaccine can prevent a 1,000 hospitalisation, so let's do that as was evident from the third wave."
India's drug regulator had approved Covovax for restricted use in emergency situations in adults on December 28 and in the 12-17 age group, subject to certain conditions, on March 9.
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.
A CDSCO panel has also recommended restricted emergency use of anti-Covid pill Molnupiravir in India.
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.
The government, earlier in October, had permitted the SII to export 10 lakh Covishield doses each to Nepal, Myanmar, and Bangladesh under the 'Vaccine Maitri' program.
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.
Biocon Biologics, a subsidiary of Biocon, on Thursday said it will offer around 15 per cent stake to Serum Institute Life Sciences at a post-money valuation of about USD 4.9 billion. Serum Institute Life Sciences (SILS) is a subsidiary of Serum Institute of India (SII).
The daily COVID-19 vaccinations crossed the 1 crore mark on Tuesday for the second time in five days, taking the total number of doses administered in the country to over 65 crore.
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.
Top News
Latest News
