Covaxin is being developed by Bharat Biotech jointly with the Indian Council of Medical Research (ICMR)- National Institute of Virology (NIV). The Phase III human clinical trials of Covaxin began mid-November, targeted to be done in 26,000 volunteers and it is the country's first and only Phase III efficacy study for a COVID-19 vaccine, a press release from the vaccine maker said on Saturday night.
The Russian vaccine has been registered in more than 55 countries and is gaining recognition in the virtual world -- being the only to have its own Facebook page, YouTube channel and a Twitter handle, reports Aneesh Phadnis
Bharat Biotech applied to the Drugs Controller General of India (DCGI) seeking permission for conducting phase 1 and phase 2 clinical trials of the intranasal vaccine following which the subject expert committee of the CDSCO on Tuesday deliberated on the application and recommended granting permission for phase 1 trial.
The vaccine candidate -- 'Covaxin' -- is being indigenously developed by the Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
'Someone may have diabetes, but at what level the disease qualifies as a comorbid condition is something a doctor will decide upon and certify accordingly.'
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.
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.
Many companies globally are working on plasma research to develop and manufacture hyperimmune globulin therapies from plasma donations.
According to sources, around 10 crore doses of the Sputnik V vaccine is likely to be imported for emergency use in the country in the next six to seven months.
The senior officials of the health ministry apprised the minister on various improvements that have been made to make the pan India dry run glitch free, such as number of telephone operators has been increased to answer every possible query from the teams on the ground conducting the dry run.
Once the UK drug regulator gives its approval to the Oxford vaccine, the expert committee on COVID-19 at the Central Drugs Standard Control Organisation (CDSCO) will hold its meeting and thoroughly review the safety and immunogenicity data from the clinical evaluations conducted abroad and in India before granting any emergency authorisation for the vaccine here, official sources said.
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.
So far, no other vaccine has been approved globally for children below 12 years. Sohini Das reports.
The phase 3 clinical trial will cover around 28,500 subjects, aged 18 years and above, and it will be conducted in 21 sites across ten states, including Delhi, Mumbai, Patna and Lucknow.
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.
The Serum Institute of India has stockpiled 40 mn-50 mn doses and is adding more every week. Most of these will come to India.
The company has developed detailed logistical plans and tools to support effective vaccine transport, storage, and temperature monitoring. Sohini Das and Ruchika Chitravanshi report.
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.
Currently, phase 2 and 3 clinical trials of the Oxford vaccine candidate is going on in the United Kingdom, phase 3 clinical trial in Brazil and phase 1 and 2 clinical trials in South Africa.
'There is no emergency of a third wave that we are rushing for booster doses.'
Union Health Minister Harsh Vardhan on Friday said the COVID-19 vaccination drive will be extended in the coming days and asserted that there should not be any misconceptions about the two Indian vaccines being administered in the country.
The institute expects to complete both, phase-2 and 3 trials in India by the end of this year.
Paul noted that "three to four months from now, there will be other vaccines and the stockpile will be even bigger. "And more acceleration can be brought about in the vaccination programme," Paul added.
The Pune-based vaccine major has entered into a collaboration with the University of Oxford and AstraZeneca to manufacture the vaccine.
As for Bharat Biotech, the Subject Expert Committee (SEC) on COVID-19 of the CDSCO asked the firm to expedite volunteer recruitment for the ongoing clinical trial and said it may conduct interim efficacy analysis for further consideration of restricted emergency use approval for its vaccine Covaxin, they stated.
At $37 per dose, the Pfizer vaccine is much more expensive compared to $3 per dose for the Covishield.
The Drug Controller General of India has sent a letter to the Glenmark seeking clarifications on pricing as well as claims of therapeutic efficacy. While Glenmark has claimed this drug is effective in comorbid conditions like diabetes, hypertension, according to protocol summary (of clinical trials) the trial was not designed to access the Fabiflu in comorbid conditions.
India's first mRNA platform-based vaccine will remain stable at 2-8 degrees Celsius while Pfizer-BioNTech's vaccine needs minus 70 degrees Celsius and Moderna vaccine can remain stable for six months at minus 20 degrees Celsius, reports Sohini Das.
Addressing a press briefing, Union Health Secretary Rajesh Bhushan said healthcare workers and frontline workers need not register themselves as their database has been populated on to the Co-WIN vaccine delivery management system in a bulk manner.
Senior Congress leader Anand Sharma on Sunday raised concerns over India's drugs regulator granting permission for restricted use of Bharat Biotech's COVID-19 vaccine and asked the government to explain why mandatory protocols and verification of data has been dispensed with.
The approval by the Drugs Controller General of India (DCGI) was given on the basis of recommendations submitted by a COVID-19 subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).
For vaccination, online registration is mandatory. Thereafter, eligible beneficiaries will be informed on their registered mobile number about the nearest vaccination facility, and the date and time of vaccination.
This is the fifth consecutive day that COVID-19 cases have increased by more than 50,000 in the country.
The dry-run was being conducted in state capitals in at least three session sites. Some states also included districts that are situated in difficult terrain or have poor logistical support, according to officials.
There were apprehensions in the SII about rival Bharat Biotech's 'indigenous' tag, opening up shortcuts for it. One senior person, who was very familiar with the sector, told me, 'The message has gone out from the very top. Somani (V G Somani -- drug controller general of India) has told me "Bharat ka karna hai".' A fascinating excerpt from Abantika Ghosh's Billions Under Lockdown: The Inside Story Of India's Fight Against COVID-19.
The vaccine would be first made available to the vulnerable population and eventually, it would be available in the private market for all.
'We must not compromise with the standard, the quality. We don't need to be the first to launch a drug but what we need is a Made in India vaccine that the entire world can rely on'
'We are rolling out a vaccine when we don't even have the phase 2 trial results; forget about phase 3 trial results.' 'Why are we playing with people's lives?'
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