'WHO & an independent group of experts are scheduled to meet next week to carry out the risk/benefit assessment and come to a final decision whether to grant Emergency Use Listing to Covaxin,' the global health body tweeted.
Covaxin is being developed by Bharat Biotech, in collaboration with the Indian Council of Medical Research - National Institute of Virology.
'We seem to be in a situation where we can do little, and nothing needs to be done anyway.'
Safety and Efficacy results from the final analysis will be available in June, and the final report will be submitted to a peer-reviewed publication.
'Even if Serum Institute and Bharat Biotech were successful in ramping up production overnight, what happens to the capacity after the demand from India is met?' asks Sanjeev Nayyar.
The first nasal vaccine against COVID-19, developed by Bharat Biotech, has received regulator's nod for conducting phase 2 clinical trials, the Department of Biotechnology said on Friday.
Covaxin is an anti-coronavirus vaccine of Bharat Biotech
A technical advisory group of the World Health Organisation was on Tuesday reviewing data on Covaxin for the emergency use listing of India's indigenously-made vaccine and it could pronounce its decision within the next 24 hours or so, a spokesperson said.
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.
While Covishield supplies would meet the target of 500 mn doses between August and December, it looks like Covaxin would miss the target of 400 mn unless the partner sites of Bharat Biotech ramp up very rapidly, reports Sohini Das.
A technical advisory group of the UN health agency which met on Tuesday has sought "additional clarifications" from Bharat Biotech for Covaxin to conduct a final "risk-benefit assessment" for Emergency Use Listing of the vaccine.
The trial will take place in 525 subjects at various sites, including AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur.
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.
According to CoWIN data, only 73 vaccination centres are currently active in India, of which 32 are government-run.
An expert panel of India's central drug authority on Wednesday recommended granting regular market approval to COVID vaccines Covishield and Covaxin for use in adult population subject to certain conditions, official sources said.
The needle-free vaccine will be available at private centres.
'Almost 70 per cent production time of a vaccine is dedicated to quality control, which is done through several hundred tests.'
Reacting to it, the vaccine maker said it is working towards resolving the issues cited during the inspection and the order of 20 million doses from the Brazilian government is still active.
Modi on Saturday will embark on a three-city tour to take stock of the COVID-19 vaccine development work.
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"The compensation for serious adverse event will be paid by sponsor (BBIL) in case if the SAE is proven to be causally related to the vaccine," the consent form said.
The ICMR-National Institute of Virology has been regularly undertaking studies to understand the protective efficacy of COVID-19 vaccines against emerging variants.
The fact sheet also asked people to inform the vaccinator or a supervising official about their medical condition before taking the vaccine.
'I would go for Bharat Biotech's Covaxin and not Covishield, and that is my personal judgment since at least 11,500 have got at least one dose by now and it has proven to be safe.'
Bharat Biotech is in the middle of conducting a phase 3 trial with 22,000 subjects.
In a series of tweets after the Drugs Controller General of India (DCGI) approved Oxford's vaccine Covishield and Bharat Biotech's Covaxin for restricted emergency use, Modi said it will make every Indian proud that both the vaccines are made in India.
Covaxin was found to have 78 per cent efficacy against COVID-19 of any severity, 14 or more days after the second dose, and is extremely suitable for low- and middle-income countries due to easy storage requirements, said the global health body.
'In case of shortage of other raw material, like filters and bags, one can try to develop another vendor. However, for chemicals as critical as adjuvants, this is not possible'
The prime minister was happy that the assurance given by the Serum Institute that it will make India self-sufficient in vaccines at the lowest possible price in the world was fulfilled.
Australia's medicines and medical devices regulator on Monday formally recognised India's Covaxin, a vaccine against the coronavirus as the country's border was reopened for the first time in nearly 20 months.
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.
Out of the 45 lakh doses, the Hyderabad-based vaccine maker will be supplying over eight lakh to some of the friendly countries such as Mauritius, Philippines and Myanmar, free of cost as good will gesture sources added.
The foreign envoys were taken to Hyderabad over a month after the ministry of external affairs briefed over 190 heads of diplomatic missions and representatives of leading international organisations on COVID-19 related issues.
Covishield comprises over 90 pc of 12.76 cr COVID vaccines administered so far
Ahmedabad was the first stop in the PM's three city tour today, to personally review the vaccine development and manufacturing process in the country.
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 vaccine maker Bharat Biotech said in a statement that preliminary reviews indicated that the death was unrelated to Covaxin.
The primary objective was to get the adult vaccine as children rarely have a severe form of the disease. Once schools reopen, the demand for vaccines for children under 12 may soar.
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.
This could also be India's first vaccine for children aged 12 years and above as the company has conducted trials on the age group. The decision, however, lies with the regulator, reports Sohini Das
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