'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.
Speaking at a virtual conference organised by the Confederation of Indian Industry, Suchitra Ella, joint Managing Director of the city-based vaccine maker, said the company's facilities in four cities -- Hyderabad, Bengaluru, Pune and Ankaleshwar -- are currently producing Covaxin.
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.
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.
Raches Ella, project lead, Covid-19 vaccines at Bharat Biotech said in a series of tweets that he was 'surprised' that media and researchers were drawing conclusions based on non-peer reviewed work.
The study titled 'Serendipitous COVID-19 Vaccine-Mix in Uttar Pradesh, India: Safety and Immunogenicity Assessment of a Heterologous Regime' has been uploaded on medRxiv, a preprint server and is yet to be peer reviewed.
Delhi currently has four days of Covaxin and three days of Covishield stock for those above 45, and healthcare and frontline workers.
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.
Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research.
Several citizens expressed anger and frustration at the state of affairs as many of them are due for their second dose since they had taken the first jab over 42 days back.
The trial is to be conducted on 525 healthy volunteers. In the trial, the vaccine will be given by intramuscular route in two doses at day 0 and day 28.
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.
He explained, "Children between the age of 12 and 18 years, particularly those in the age group of 15 to 18 years, are very much like adults. Our research within the country also says that almost two-thirds of the deaths below 18 years which occurred due to COVID in India are within this age group. So, this decision was mainly taken to protect the adolescents."
Bharat Biotech had said last month that it expects approval for its COVID-19 vaccine Covaxin from the World Health Organisation for emergency use listing during July-September.
The Rhesus macaque monkeys, used worldwide in medical research, are believed to be the best non-human primates for such studies.
The Centre's supplying price is pushing the pricing structure for the private sector upward.
The Hyderabad-based manufacturer uses a proprietary adjuvant Algel-IMDG, which has now proven to be a safe and effective adjuvant, especially to stimulate memory T cell responses.
Covaxin is an anti-coronavirus vaccine of Bharat Biotech
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.
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.
India's apex drug regulator has granted permission for conducting the phase II/III clinical trial of Bharat Biotech's Covaxin COVID-19 vaccine in the age group of 2 to 18 years, the Union Health Ministry said on Thursday.
The move follows the World Health Organisation's Emergency Use Listing for Covaxin, which is the second most used formulation in India.
Anil Vij was administered the trial dose of the indigenous COVID vaccine Covaxin last month
Facts have been "twisted and misrepresented" in some social media posts which suggested that indigenously developed Covaxin contains newborn calf serum, the Union health ministry said in a statement on Wednesday.
In September, Bharat Biotech aimed to supply 35 million doses, and take this up to 55 million by October. This is still less than what the Indian government expects from the company.
Bharat Biotech on Thursday said it plans to produce additional 200 million doses of COVID-19 vaccine 'Covaxin' at its subsidiary's Ankleshwar (Gujarat) based facility, taking the overall production volume of the vaccine to 1 billion (100 crore) dosages per annum.
In a setback that could potentially delay the launch of Bharat Biotech's Covid-19 vaccine Covaxin in USA, the Food and Drug Administration there has "recommended" Ocugen Inc, the US partner of the Indian vaccine maker, to go for Biologics Licence Application (BLA) route with additional data, nixing hopes of Emergency Use Authorisation.
"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.
'He came back from the US only to work for his country.' 'He has invested his fortunes to build this company and is married to his work.' 'Rarely does one see such commitment.'
'The residents are a bit apprehensive about the lack of complete trial in case of Covaxin and might not participate in huge numbers thus defeating the purpose of vaccination. We request you to vaccinate us with Covishield which has completed all stages of trial before its roll-out'
The company said regulatory approvals for Covaxin are in process in more than 60 countries including the USA, Brazil and Hungary among others.
The phase-three human clinical trial of indigenously developed anti-coronavirus vaccine candidate Covaxin began at the AIIMS in New Delhi on Thursday, with Dr M V Padma Srivastava, the chief of Neurosciences Centre at the premier institute, and three other volunteers receiving the first dose.
The most important finding of the study was that the Spike-protein neutralising antibodies found in the mixed vaccine groups were significantly higher than the same-vaccine groups, D Nageshwar Reddy, Chairman of AIG Hospitals said.
Amid the reports of coronavirus vaccine shortage from various states, the central government and Hyderabad-based Bharat Biotech are willing to invite other companies which want to produce COVAXIN in a bid to scale up the vaccine production, said NITI Aayog member Dr VK Paul, on Thursday.
Vaccine major Bharat Biotech on Wednesday said its COVID-19 vaccine, Covaxin, has demonstrated an interim vaccine efficacy of 81 per cent in the Phase 3 clinical trials.
Hyderabad-based vaccine manufacturer Bharat Biotech, which is carrying out its phase 3 trial will publish the data in July following that the company will be applying for the full licensure of Covaxin.
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 panel also recommended giving approval to Bharat Biotech for carrying out a study on interchangeability of its Covaxin and the under-trial adenoviral intranasal vaccine candidate BBV154, but asked the Hyderabad-based firm to remove the word "interchangeability" from the study title and submit a revised protocol for approval.
Senior Congress leader Manish Tewari and Union Health Minister Harsh Vardhan sparred on Twitter on Saturday with the Opposition leader raising questions over the emergency use approval given to the indigenously developed vaccine Covaxin and the Bharatiya Janata Party leader hitting back alleging that Tewari was only passionate about spreading rumours.
The New York Times on Tuesday said Covaxin works by teaching the immune system to make antibodies against the SARS-CoV-2 coronavirus. The antibodies attach to viral proteins, such as the so-called spike proteins that stud its surface.
© 2026 Rediff.com - Investor Information - Advertise with us - Disclaimer - Privacy Policy - Sitemap - Feedback - About us - Terms of use - Grievances