Covovax is likely to be available on the portal in a few days at a price of Rs 225 per dose plus applicable GST.
The DCGI's approval came following recommendation by the Subject Expert Committee of the Central Drugs Standard Control Organisation.
It has been approved by the European Medicines Agency for conditional marketing authorisation.
The Pune-based firm had submitted interim safety and immunogenicity data of phase 2/3 bridging clinical trial conducted in the country as well as interim clinical trial data of safety and efficacy from phase3 clinical trials conducted in the UK and the US along with its application.
'WHO issued an emergency use listing for Covovax, expanding the basket of WHO-validated vaccines against COVID-19. The vaccine is produced by the Serum Institute of India under licence from Novavax,' the world health body said in a tweet on Friday.
There were no safety concerns arising from the study data and Covovax is safe and immunogenic in the adult population, Prakash Kumar Singh, Director, Government and Regulatory Affairs at the Serum Institute of India (SII), is learnt to have said in the application sent to the DCGI.
Vaccine major Serum Institute of India on Tuesday said the approval for the COVID-19 vaccine 'Covovax' would strengthen immunization initiatives across India and various lower and middle income countries across the world.
Confirming the Drugs Controller General Of India (DCGI) approval, Serum Institute of India CEO Adar Poonawalla on Tuesday tweeted: '@SerumInstIndia's brand Covovax has completed bridging studies in India and has been granted Emergency Use Authorisation by DCGI for adults and for children above the age of 12. Younger age groups will follow shortly.'
The Serum Institute of India (SII) had put in an application to the Drugs Controller General of India (DCGI) in October for grant of market authorisation of Covovax for restricted use in emergency situations.
On production capacity of Covishield, the vaccine being manufactured and supplied by Serum in India under a licensing agreement with Oxford and AstraZeneca, he said the present capacity is 130 million doses per month and always try to increase it further.
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.
An expert panel of India's Central Drug Authority on Tuesday recommended granting permission to Serum Institute of India (SII) for conducting phase 2/3 trials of Covid vaccine Covovax on children aged 2 to 17 years with certain conditions, official sources said.
'I understand some people are comfortable getting a Covishield shot as their third dose.'
Poonawalla was talking to media persons amid rising cases of coronavirus infections in the country since March.
'We seem to be in a situation where we can do little, and nothing needs to be done anyway.'
Serum Institute of India (SII) CEO Adar Poonawalla on Wednesday said it has restarted manufacturing of Covid-19 vaccine Covishield amid rising numbers of cases of the virus infection.
According to CoWIN data, only 73 vaccination centres are currently active in India, of which 32 are government-run.
India has covered enough population with vaccine and infection, but protein vaccines should remain available on payment basis for elderly and those with comorbidities.
Serum Institute of India (SII) and Bharat Biotech have also stopped producing the Covishield and Covaxin vaccines respectively.
Currently, Covishield and other COVID vaccines are approved for people above the age of 18 years.
The announcement comes a day after the Subject Expert Committee (SEC) on COVID-19 of the CDSCO recommended granting emergency use authorisation (EUA) to the COVID-19 vaccines Covovax and Corbevax with certain conditions.
The quantity of Covid vaccines to be exported will be decided by the government every month to ensure there is no dearth of domestic availability.
The Covid-19 vaccine demonstrated an overall 90.4 per cent efficacy in phase 3 clinical trials, reports Sohini Das
Poonawalla said booster vaccines have no demand as there is general lethargy among people and also because they are fed up with the pandemic.
Adar Poonawalla said he was hopeful that Covovax, the Novavax vaccine made by SII, will be launched around October this year for adults and for children by the first quarter of next year, depending on DCGI approvals.
India expects 2.16 billion doses of Covid-19 vaccines between August and December, including the jabs that are currently in clinical trials, reports Sohini Das
Both manufacturers have sought funds in excess of Rs 150 crore under the department of biotechnology's Mission Covid Suraksha scheme. Announced last November, the scheme has an outlay of Rs 900 crore to help develop Covid vaccines, from the clinical development stage to setting up production sites.
The development comes after requests for indemnity and exemption from bridging trials have been made by Pfizer and Moderna to the Indian government.
Behind each Covid vaccine are hundreds of parents, who had the courage and conviction to come forth with their children for the trial of a vaccine which was, until then, untried in that age group, reports Sindhu Bhattacharya.
The government on Thursday took a series of measures in view of the rising number of COVID-19 cases in several parts of the world, including China.
A back of the envelope calculation shows that India has roughly over 680 million doses of Covid-19 vaccines consisting primarily of Covishield doses.
The Central Drugs Standard Control Organisation has granted restricted emergency use authorisation to two new vaccines and a drug for COVID-19, taking the number of preventives and treatments available in India to 12.
'SII has started stockpiling the vaccine and now has roughly 40 million doses ready. It is using some of the capacities it had for under development products for the COVID-19 vaccine and by January we will have a capacity to make 100 million doses per month and a stockpile of 200 million doses.'
865 million Indian adults require vaccination.
'Your body will be able to deal with Omicron at any time, but it depends (on when) if you are vaccinated.'
The Drugs Controller General of India has approved the manufacture of this Sars-CoV-2 spike protein recombinant nano-particle vaccine for 'examination, test, and analysis', reports Sohini Das.
Poonawalla also warned against the return to 'the business as usual' approach of the administration in the national capital, saying 'we can't afford to put a price tag on the life of a citizen' as the pandemic is 'not behind us yet nor we know by when it will be'.
Biological E has received approval for conducting phase II/III human clinical trial of COVID-19 vaccine candidate Corbevax on children above five years and adolescents, the Department of Biotechnology (DBT) said on Friday.
The Subject Expert Committee on COVID-19 of the CDSCO on October 12 after deliberating Bharat Biotech's EUA application had recommended granting emergency use approval to Covaxin for use in the 12-18 years age group with certain conditions.
Benchmark indices Sensex and Nifty retreated from over one-week highs to close lower on Wednesday due to profit booking in banking, IT and metal stocks amid weak global trends. After a two-day rally, the 30-share BSE Sensex dropped by 90.99 points or 0.16 per cent to settle at 57,806.49 in volatile trade. As many as 19 of its constituents declined while 11 advanced. The broader Nifty slipped by 19.65 points or 0.11 per cent to close at 17,213.60 with 31 of its stocks ending in the red.
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