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.
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.
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.
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 global health agency also emphasized that it must evaluate a vaccine thoroughly to make sure it is "safe and effective".
'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.
Bharat Biotech is also looking at nasal vaccine as a booster dose as its scaling up capacity is very easy when compared with Covaxin, he added.
Covaxin is an anti-coronavirus vaccine of Bharat Biotech
'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.
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.
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.
Modi on Saturday will embark on a three-city tour to take stock of the COVID-19 vaccine development work.
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.
The trial will take place in 525 subjects at various sites, including AIIMS, Delhi, AIIMS, Patna and Meditrina Institute of Medical Sciences, Nagpur.
Serious AESI, which included stroke and Guillain-Barre syndrome, were reported in one per cent of individuals, the study, which looked at long-term safety of the BBV152 vaccine in adolescents and adults, claimed.
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.
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.
Dominic Xavier ponders the Vaccine Dilemma: Should he take the shot or not?
"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.
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.
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.
The fact sheet also asked people to inform the vaccinator or a supervising official about their medical condition before taking the vaccine.
'Almost 70 per cent production time of a vaccine is dedicated to quality control, which is done through several hundred tests.'
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.
Bharat Biotech is in the middle of conducting a phase 3 trial with 22,000 subjects.
'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.'
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.
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.
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.
'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'
India witnessed a record-breaking surge in deal activity in February, with 226 M&A and private equity deals totaling $7.2 billion -- the highest monthly deal volume in the last three years, according to the Dealtracker report of Grant Thornton Bharat. "This represents a 67 per cent increase in volumes and a 5.4-fold increase in values compared to February 2024, while a 14 per cent increase over the previous month," it said.
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 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.
Covishield comprises over 90 pc of 12.76 cr COVID vaccines administered so far
In a statement Bharat Biotech clarified that the vaccine's efficacy can only be determined 14 days after the second dose.
The vaccine maker Bharat Biotech said in a statement that preliminary reviews indicated that the death was unrelated to Covaxin.
Ahmedabad-based Zydus Cadila, Bharat Biotech's intra-nasal candidate are among the candidates who got approval from the expert panel to conduct clinical trials, Sohini Das reports.
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.
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