India has covered enough population with vaccine and infection, but protein vaccines should remain available on payment basis for elderly and those with comorbidities.
The Union health ministry on Thursday termed as 'misleading' and 'fallacious' media reports which claimed that regulatory approval for COVID-19 vaccine Covaxin was rushed due to political pressure.
According to CoWIN data, only 73 vaccination centres are currently active in India, of which 32 are government-run.
An expert panel of the country's drugs regulatory authority had recommended against granting such approval to the firm at this stage just two days ago, officials said.
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.
The approval by the Drugs Controller General of India comes following recommendations by the Subject Expert Committee on COVID-19 of the Central Drugs Standard Control Organisation.
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.'
Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research.
The Drugs Controller General of India will take a final call on the recommendation. If approved, it will be the third COVID-19 vaccine to be available in India.
Covaxin is being indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
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.
This is the world's first DNA-based vaccine against the coronavirus, and this three-dose vaccine when injected produces the spike protein of the SARS-CoV-2 virus and elicits an immune response, which plays a vital role in protection from the disease as well as viral clearance
Addressing a press briefing, Union Health Secretary Rajesh Bhushan said Zydus Cadila, Sputnik V, Biological E and Gennova are other vaccines also in the pipeline which are in advanced clinical trials in India.
An expert committee of the Central Drugs Standard Control Organisation (CDSCO) on Wednesday sought additional safety and efficacy data for COVID-19 vaccine candidates of Serum Institute and Bharat Biotech, after deliberating upon their applications seeking emergency use authorisation for the shots, official sources said.
"India expands its vaccine basket! Johnson and Johnson's single-dose COVID-19 vaccine is given approval for Emergency Use in India. Now India has 5 EUA vaccines. This will further boost our nation's collective fight against COVID-19," tweeted the minister.
Briefing the media in Rome, Goyal said the Leaders adopted the 'Rome Declaration' at the G20 Summit and the communique gives a very strong message under the health section with the countries agreeing that the COVID-19 immunisation is a global public good.
The Serum Institute of India, Bharat Biotech and Pfizer have applied to the DCGI seeking emergency use authorisation for their COVID-19 vaccine candidates and are awaiting approval.
SII is the first indigenous company that has sought emergency approval for the vaccine developed along with global pharma giant AstraZeneca and Oxford University.
The Subject Expert Committee on COVID-19 examined the data and deliberated on the EUA application on Monday.
Over the last four days, the Indian arm of US pharmaceutical giant Pfizer, Pune-based Serum Institute of India and Hyderabad-based pharmaceutical firm Bharat Biotech have applied to the Drugs Controller General of India seeking emergency use authorisation for their COVID-19 vaccines.
Healthcare and frontline workers and citizens above 60 years of age with comorbidities would be administered the third dose of the same vaccine they had been given before.
The company said regulatory approvals for Covaxin are in process in more than 60 countries including the USA, Brazil and Hungary among others.
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.
Nearly 50 million doses of Bharat Biotech's COVID-19 vaccine, Covaxin lying with the firm are set to expire early next year as there are no takers owing to poor demand, company sources said.
A statement issued by the WHO on Saturday said the suspension is in response to the outcomes of its post EUL (emergency use authorisation) inspection held between March 14-22, 2022 and the need to conduct process and facility upgrade to address recently identified GMP (good manufacturing practice) deficiencies.
Sputnik V is already approved in India and Sinovac is unlikely to come in as it does not meet the criteria.
The trial is being conducted in three phases by segregating children into categories according to their age. The first trial was started in the age group of 12 to 18 years followed by the age group of 6 to 12. Trials for children between the ages of and 2-6 years are currently undergoing trials.
More than 200 million Pfizer doses have been administered in the US, and hundreds of millions more worldwide, since December.
Serum Institute has the capacity to make 250 million doses of Covishield monthly.
The firm presented that Sputnik Light vaccine is approved in 29 countries, including Russia and Argentina.
Under the conditions, the firms shall submit data of ongoing clinical trials and the vaccines to be supplied for programmatic setting.Adverse event following immunisation will continue to be monitored.
Drug firm Zydus Cadila on Thursday said it has applied for emergency use authorisation (EUA) with the Indian drug regulator for its three-dose COVID-19 vaccine ZyCoV-D, and plans to manufacture 10-12 crore doses annually.
The vaccine option for this age group would only be Covaxin, according to guidelines issued by the Union Health Ministry on December 27.
Bharat Biotech recruited 13,000 participants for the Phase-3 clinical trial of Covaxin. This is one of the largest efficacy trials held in the country.
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.
'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.
Dr Reddy's, which has tied up with Russian Direct Investment Fund for Sputnik V in India, soft launched the vaccine in India in May 2021, after receiving Emergency Use Authorisation in April 2021.
The Standing Technical Sub-Committee (STSC) of the National Technical Advisory Group on Immunisation (NTAGI) on Thursday recommended reducing the gap between the second and precaution doses of COVID-19 vaccines from the current nine to six months, official sources said.
As many as 34 new drugs were added to and 26 dropped from an updated list of essential medicines on Tuesday, with the government saying this will reduce "patients' out-of-pocket expenditure". The National List of Essential Medicines (NLEM 2022) has 384 drugs, up from 376 in 2015. "Drafting this list is a lengthy process, and around 350 experts from across India have held over 140 consultation meetings to draft the NLEM 2022," Union Health Minister Mansukh Mandaviya said.
In a report submitted Monday to Rajya Sabha chairman and Vice President M Venkaiah Naidu, the Parliamentary Standing Committee on Home Affairs also said there was a need for a comprehensive public health law to keep a tab on private hospitals and check black-marketing of medicines.
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