Covaxin Granted EUL by WHO: Tracing The COVID-19 Vaccine's Journey
3 years, 1 month ago

Covaxin Granted EUL by WHO: Tracing The COVID-19 Vaccine's Journey

The Quint  

On 7 December Bharat Biotech officially applied for Emergency Use Authorisation for Covaxin. On 9 December, However, the DGCI asked Bharat biotech to submit more data for Covaxin before it could be granted an EUA. On 2 January 2021, Covaxin received EUA from the DGCI for restricted use "in public interest as an abundant precaution, in clinical trial mode, specially in the context of infection by mutant strains”. On 3 March, it was then announced that interim results of the phase 3 clinical trials for Covaxin showed an 81% efficacy in preventing COVID. Quickly, following this, on 11 March, the Drugs Controller General of India, announced that Bharat Biotech’s Covaxin was no longer in 'clinical trial mode', although it remains approved under an EUA.

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History of this topic

ICMR got ₹172 cr. from Bharat Biotech for Covaxin: Nadda
4 months, 3 weeks ago

ICMR got ₹172 cr. from Bharat Biotech for Covaxin: Nadda

The Hindu  

The Indian Council of Medical Research has received ₹172 crore as royalty from Bharat Biotech International Limited for jointly developing Covaxin, an indigenously developed vaccine for COVID-19, Union Health Minister J.P. Nadda said, during Question Hour in the Lok Sabha on Friday. Covaxin was jointly developed by ICMR, National Institute of Virology, and Bharat Biotech International Ltd, in two phases. …

The right way to counter a poor Covaxin safety study
4 months, 3 weeks ago

The right way to counter a poor Covaxin safety study

The Hindu  

It took all of five days for the Indian Council of Medical Research to strongly criticise the poor design of the long-term safety study of Covaxin by researchers from the Banaras Hindu University, Varanasi. A publication failure that is glaring Three years after the interim data were posted as a preprint, Bharat Biotech and ICMR are yet to publish any …

BHU study: Over 30 per cent of Covaxin recipients report adverse events
7 months, 1 week ago

BHU study: Over 30 per cent of Covaxin recipients report adverse events

India TV News  

A recent study conducted by researchers at Banaras Hindu University revealed that over 30% of individuals who received Bharat Biotech's Covaxin reported adverse events. The one-year follow-up study, encompassing 926 participants, shed light on the long-term safety of the BBV152 vaccine, with serious adverse events of special interest such as stroke and Guillain-Barre syndrome reported in one per cent of …

‘Safety is primary focus’: Covaxin-developer amid reports on AstraZeneca vaccine
7 months, 3 weeks ago

‘Safety is primary focus’: Covaxin-developer amid reports on AstraZeneca vaccine

Hindustan Times  

Amid reports over potential rare side effects of the AstraZeneca-Oxford COVID-19 vaccine, Bharat Biotech, which developed the Covaxin, said in a statement that the vaccine was developed with a "single-minded focus on safety first." It stated that Covaxin was the "only Covid vaccine" in government of India's COVID-19 immunisation program to have conducted efficacy trials in India. "@bharatbiotech announcement - …

A new regime: On the Emergency Use Authorisation regime in India and clinical trials
1 year, 5 months ago

A new regime: On the Emergency Use Authorisation regime in India and clinical trials

The Hindu  

Last week, the Drug Controller General of India cleared, under the provisions of ‘emergency use authorisation’, a new mRNA vaccine for COVID-19 developed by Pune-based Gennova Biopharmaceuticals, a pioneer in India in developing mRNA vaccines. More than evidence-based assessment, it was a technicality in India’s ‘New Drugs and Clinical Trials Rules, 2019’ that allowed EUA in India for COVID-19 vaccines. …

Serum institute seeks to add Covovax on CoWIN portal as booster dose for adults
1 year, 8 months ago

Serum institute seeks to add Covovax on CoWIN portal as booster dose for adults

Hindustan Times  

Amid rising coronavirus cases, the Serum Institute of India has written a letter to the Union health ministry seeking the inclusion of its COVID-19 vaccine Covovax on the CoWIN portal as a heterologous booster dose for adults, official sources said on Monday. The letter was written by Prakash Kumar Singh, Director, Serum Institute of India on March 27, they said. …

DCGI Approves Market Authorisation for SII's Covid Vaccine Covovax as Heterologous Booster Dose
1 year, 11 months ago

DCGI Approves Market Authorisation for SII's Covid Vaccine Covovax as Heterologous Booster Dose

News 18  

The Drug Controller General of India has approved market authorisation to COVID-19 vaccine Covovax as a heterologous booster dose for adults who have been administered two doses of Covishield or Covaxin, official sources said on Monday. Prakash Kumar Singh, Director of Government and Regulatory Affairs at the Serum Institute of India, had recently written to the DCGI for the approval …

Covid: 250 million Corbevax, Covaxin in stock, ready for dispatch
1 year, 11 months ago

Covid: 250 million Corbevax, Covaxin in stock, ready for dispatch

Hindustan Times  

Around 250 million Covid vaccines manufactured by two major Hyderabad-based units – Biological E and Bharat Biotech – are ready for dispatch in the market as soon as orders are received. Nearly 200 million Corbevax vaccine of Biological E and 50 million of Bharat Biotech's Covaxin are stockpiled at the moment. Read| Covid drills at hospitals; case count remains low …

Biological E, Bharat Biotech Together Sitting on Stockpile of 250 Million Covid Vaccine Doses
1 year, 11 months ago

Biological E, Bharat Biotech Together Sitting on Stockpile of 250 Million Covid Vaccine Doses

News 18  

Two major vaccine makers from Hyderabad, Biological E Ltd and Bharat Biotech, together are holding about 250 million doses of Covid-19 vaccines ready to dispatch as and when orders are received. According to respective company sources, Biological E is holding 200 million doses of its Covid-19 vaccine Corbevax while Bharat Biotech is sitting on a stockpile of 50 million doses …

Covid: Biological E, Bharat Biotech together holding 250 million vaccine doses
1 year, 11 months ago

Covid: Biological E, Bharat Biotech together holding 250 million vaccine doses

Live Mint  

The two major Hyderabad-based vaccine manufacturing units, Biological E and Bharat Biotech, together are holding about 250 million Covid vaccine doses ready to dispatch as and when orders are received, according to news agency PTI. Currently, Biological E is holding 200 million doses of its Covid-19 vaccine Corbevax while Bharat Biotech is sitting on a stockpile of 50 million doses …

Biological E, Bharat Biotech have stockpile of 250 million COVID vaccine doses
1 year, 11 months ago

Biological E, Bharat Biotech have stockpile of 250 million COVID vaccine doses

India TV News  

As Covid cases are increasing in the country, now focus is back on vaccination drive. According to sources- two major vaccine makers from Hyderabad, Biological E Ltd and Bharat Biotech, together have about 250 million doses of COVID-19 vaccines ready to dispatch as and when orders are received. Corbevax and Covaxin stocks Biological E held 200 million doses of its …

COVID-19: Centre approves Bharat Biotech's intranasal vaccine, to be available on CoWIN
2 years ago

COVID-19: Centre approves Bharat Biotech's intranasal vaccine, to be available on CoWIN

Firstpost  

The needle-free vaccine will be available at private centres. It will be introduced on the Co-WIN platform on Friday evening New Delhi: Bharat Biotech’s intranasal COVID-19 vaccine has been approved by the Ministry of Health and Family Welfare for inclusion in the vaccination programme as a booster dose for those above 18 years of age, official sources said on Thursday. …

SII Seeks Drug Regulator's Nod for Market Authorisation of Covovax Vaccine as Covid-19 Booster Dose
2 years ago

SII Seeks Drug Regulator's Nod for Market Authorisation of Covovax Vaccine as Covid-19 Booster Dose

News 18  

The Serum Institute of India has sought the drug regulator’s approval for market authorisation of its COVID-19 vaccine Covovax as a booster dose for those aged 18 years and above who have been administered two doses of Covishield or Covaxin, official sources said on Thursday. Prakash Kumar Singh, director, government and regulatory affairs, SII, submitted a market authorisation application for …

Bharat Biotech urges Centre to include its intranasal COVID vaccine in CoWIN portal
2 years ago

Bharat Biotech urges Centre to include its intranasal COVID vaccine in CoWIN portal

Deccan Chronicle  

Hyderabad: Bharat Biotech has requested the central government to include its intranasal COVID-19 vaccine iNCOVACC, in CoWIN portal to enable the recipients of the jab to get vaccination certificate. The company sources said Bharat Biotech is currently holding discussions with international “potential partners” who have approached the company for manufacturing and distribution of the intranasal vaccine globally. “Since iNCOVACC has …

Bharat Biotech misstated Covaxin trial data
2 years ago

Bharat Biotech misstated Covaxin trial data

Deccan Chronicle  

HYDERABAD: Extremely serious procedural leniencies and incorrect reporting of the results of trials of Covaxin, Bharat Biotech’s anti-Covid vaccine, have come to light, raising some very uncomfortable questions on the vaccine’s rollout for general use in India. Inquiries and investigation into the three phases of human trials of Covaxin have found grave reporting errors – some that appear to be …

Govt, Bharat Biotech Deny ‘Shortcut’ in Covaxin Trials: What's the Controversy?
2 years, 1 month ago

Govt, Bharat Biotech Deny ‘Shortcut’ in Covaxin Trials: What's the Controversy?

The Quint  

The allegations: Here's a quick run through of the STAT report. It said that Bharat Biotech: Omitted data of some participants in the phase 1 trial when the study was published in a medical journal. The report says they had access to internal documents from the company, and they also quote people in the company, including Krishna Mohan, one of …

50 million doses of Covaxin set to expire early 2023 due to poor offtake
2 years, 1 month ago

50 million doses of Covaxin set to expire early 2023 due to poor offtake

The Hindu  

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. Due to lack of product demand, production stoppage of Covaxin - a two dose jab, was initiated by Bharat Biotech earlier this year, though the vaccine maker …

COVID: 50 million Covaxin doses set to expire early 2023 due to poor off take
2 years, 1 month ago

COVID: 50 million Covaxin doses set to expire early 2023 due to poor off take

India TV News  

Highlights Covaxin lying with the firm are set to expire early next year There are no takers owing to poor demand, said company sources India reported 1,082 fresh COVID-19 cases on Saturday Covaxin news: 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 …

COVID-19: Delhi High Court Closes Plea Challenging Centre's Permission For Clinical Trials Of Covaxin Among 2-18 Yrs Old
2 years, 3 months ago

COVID-19: Delhi High Court Closes Plea Challenging Centre's Permission For Clinical Trials Of Covaxin Among 2-18 Yrs Old

Live Law  

The Delhi High Court has disposed of a plea filed during the second wave of COVID-19 against Centre's permission for conducting Phase II and III clinical trials of Covaxin in the age group of 2 to 18 years. A division bench comprising of Chief Justice Satish Chandra Sharma and Justice Subramonium Prasad took note of the Supreme Court's judgment in …

COVID-19 intranasal vaccine Phase III trials over, proven safe, says Bharat Biotech
2 years, 4 months ago

COVID-19 intranasal vaccine Phase III trials over, proven safe, says Bharat Biotech

Deccan Chronicle  

HYDERABAD: Bharat Biotech International Limited on Monday said its COVID-19 intranasal vaccine has proven to be safe, well-tolerated, and immunogenic in subjects in controlled clinical trials phase III. Product development related to pre-clinical safety evaluation, large-scale manufacturing scale-up, formulation, and delivery device development, including human clinical trials, was conducted by Bharat Biotech. Suchitra K Ella, Joint Managing Director, Bharat Biotech, …

Corbevax approved as booster for those jabbed with Covishield, Covaxin: Report
2 years, 4 months ago

Corbevax approved as booster for those jabbed with Covishield, Covaxin: Report

Live Mint  

The government has approved Biological E's Corbevax as a precaution dose for those above 18 years fully vaccinated with either Covishield or Covaxin, news agency PTI has reported on 10 August citing official sources. "Corbevax will be considered as a precaution dose after completion of six months or 26 weeks from the date of administration of the second dose of …

In A First, Biological E's Corbevax Approved As Covid Booster for Covishield, Covaxin Recipients
2 years, 4 months ago

In A First, Biological E's Corbevax Approved As Covid Booster for Covishield, Covaxin Recipients

News 18  

The Centre has approved Biological E’s Corbevax as a Covid-19 precaution dose for those above 18 years fully vaccinated with either Covishield or Covaxin. Union Health Secretary Rajesh Bhushan said, “Corbevax will be available as precaution dose after completion of six months or 26 weeks from the date of administration of the second dose of either Covaxin or Covishield vaccines …

Corbevax, Covaxin vacines get nod for use among 5-12 years olds; details here
2 years, 5 months ago

Corbevax, Covaxin vacines get nod for use among 5-12 years olds; details here

Live Mint  

Biological E's Corbevax and Bharat Biotech's Covaxin on July 8 received the nod from the National Technical Advisory Group on Immunisation's Standing Technical Sub-Committee for use among children aged between 5-12 years. The Drugs Controller General of India granted emergency use authorisation to the Biological E's Corbevax for 5-12 year old and Bharat Biotech's Covaxin for minors belonging to the …

Allowing Corbevax as booster for those vaccinated with Coivishield, Covaxin likely to be considered by NTAGI
2 years, 5 months ago

Allowing Corbevax as booster for those vaccinated with Coivishield, Covaxin likely to be considered by NTAGI

The Hindu  

Allowing Biological E’s Corbevax as a booster for those fully vaccinated against COVID-19 with either Covishield or Covaxin is likely to be considered by the NTAGI, which is scheduled to meet on Tuesday, sources said. “The National Technical Advisory Group on Immunisation will discuss allowing Corbevax, which has been cleared by the DCGI, as a booster for those fully vaccinated …

Bharat Biotech Nasal Covid Vaccine's Phase 3 Trials Completed
2 years, 6 months ago

Bharat Biotech Nasal Covid Vaccine's Phase 3 Trials Completed

News 18  

Bharat Biotech on Saturday said that the clinical Phase III trials of the nasal vaccine for Covid-19 have been completed and that the company will submit its data with Drugs Controller General of India next month. Dr Krishna Ella, Chairman and Managing Director of Bharat Biotech on Saturday said, if everything is okay, then they will get permission to launch …

COVID-19: Nasal vaccine's phase 3 trial completed, informs Bharat Biotech chief
2 years, 6 months ago

COVID-19: Nasal vaccine's phase 3 trial completed, informs Bharat Biotech chief

Firstpost  

Dr Krishna Ella said that the company will submit its data with Drugs Controller General of India next month and If everything is okay, it will be the world’s first clinically proven nasal COVID-19 vaccine Dr Krishna Ella, Chairman and Managing Director of Bharat Biotech on Saturday said that the clinical phase III trials of the COVID-19 nasal vaccine have …

Covaxin demonstrates robust safety and immunogenicity in children 2-18 years: Bharat Biotech
2 years, 6 months ago

Covaxin demonstrates robust safety and immunogenicity in children 2-18 years: Bharat Biotech

The Hindu  

Bharat Biotech International Limited, on Friday, announced that COVID-vaccine Covaxin has proven to be safe, well-tolerated, and highly immunogenic in paediatric subjects in phase II/III study. The company in its press release said that Bharat Biotech had conducted phase II/III, open-label, and multi-centre study to evaluate the safety, reactogenicity, and immunogenicity Covaxin in healthy children and adolescents in 2-18 years …

Covaxin safe, well-tolerated in 2-18 years age-group, announces Bharat Biotech
2 years, 6 months ago

Covaxin safe, well-tolerated in 2-18 years age-group, announces Bharat Biotech

Firstpost  

The clinical trial conducted in the paediatric population between June 2021 to September 2021 has shown safety, less reactogenic, and robust immunogenicity Hyderabad: Bharat Biotech International Limited on Friday announced that its COVID-19 vaccine Covaxin has proven to be safe, well-tolerated and highly immunogenic in paediatric subjects in phase II/III study. Bharat Biotech had conducted phase II/III, open-label, and multi-centre …

Germany recognises Bharat Biotech's Covaxin for travel from June 1
2 years, 6 months ago

Germany recognises Bharat Biotech's Covaxin for travel from June 1

India TV News  

Highlights WHO in November last year issued an emergency use listing for Covaxin The step added a growing portfolio of vaccines validated for the prevention of COVID-19 WHO's EUL procedure assesses the quality, safety and efficacy of COVID-19 vaccines Germany has recognised the WHO-listed Bharat Biotech's COVID vaccine Covaxin, for travel to the country starting June 1. World Health Organization …

No Haste In Granting Emergency Use Authorization To Covaxin & Covishield: Supreme Court
2 years, 7 months ago

No Haste In Granting Emergency Use Authorization To Covaxin & Covishield: Supreme Court

Live Law  

In its judgment holding that the policy of the Union Government on COVID-19 vaccination policy is reasonable, the Supreme Court rejected the contention that restricted emergency use approvals had been granted to COVISHIELD and COVAXIN in haste, without thorough review of the relevant data.The court observed that the challenge to the procedures adopted by the expertbodies while granting. "However, it …

SEC seeks more data from Serum Institute of India over COVID vaccine 'Covovax' for 7-12 age group: Sources
2 years, 7 months ago

SEC seeks more data from Serum Institute of India over COVID vaccine 'Covovax' for 7-12 age group: Sources

India TV News  

Highlights DCGI subject expert committee on April 29 sought more data from SII on Covovax vaccine SEC has sought more data for Covovax vaccine for 7-12 years age group Covovax has already been recommended by DCGI for children above 12 years of age Coronavirus vaccine: The Drugs Controller General of India's subject expert committee on Friday sought more data from …

In haste: The Hindu Editorial on vaccinating children against COVID-19
2 years, 7 months ago

In haste: The Hindu Editorial on vaccinating children against COVID-19

The Hindu  

The emergency use authorisation granted on April 26 to two COVID-19 vaccines — Corbevax for children 5-11 years, and Covaxin for children 6-11 years — is one more instance where the Indian drug regulator has acted in haste. Even if the EUA granted to Covaxin in January 2021 despite no safety and efficacy data of the phase-3 trial is condoned …

India Could Start Vaccinating Younger Kids Soon as Govt Panel Suggests Covaxin for 6-12 Age Group​ - News18
2 years, 8 months ago

India Could Start Vaccinating Younger Kids Soon as Govt Panel Suggests Covaxin for 6-12 Age Group​ - News18

News 18  

Amid a resurgence of Covid-19 cases, especially among children, the focus is back on vaccinating kids and now, there are indications from the government that India could soon start coronavirus jabs for younger children. Covaxin in the 6-12 age group The Subject Expert Committee has recommended Bharat Biotech’s Covaxin to the Drug Controller General of India for children aged between …

Bharat Biotech asked to provide more data on Covaxin for below 12-year-olds
2 years, 8 months ago

Bharat Biotech asked to provide more data on Covaxin for below 12-year-olds

Deccan Chronicle  

New Delhi: The Subject Expert Committee of the Drug Controller General of India has asked Bharat Biotech for additional data on its COVID-19 vaccine, Covaxin, for administering it to children aged between 2-12 years, sources said. This development comes after the Subject Expert Committee discussed recommendations for the restricted emergency of Covaxin in children aged between 2-12 years. However, the …

Govt panel approves use of Corbevax for 5-12 year age group
2 years, 8 months ago

Govt panel approves use of Corbevax for 5-12 year age group

India Today  

Expert panel of Drug Controller General of India -- India’s drug regulator-- has recommended granting emergency use authorisation for Biological E's Covid-19 vaccine Corbevax for children in 5 to 12 years age group. "The Subject Expert Committee on COVID-19 of the CDSCO which deliberated on Biological E's EUA application has recommended granting emergency use authorisation for use of Corbevax in …

Morning Digest | Four militants behind J&K targeted killings shot dead; Covaxin trials in U.S. put on hold, and more
2 years, 8 months ago

Morning Digest | Four militants behind J&K targeted killings shot dead; Covaxin trials in U.S. put on hold, and more

The Hindu  

Four dead in Shopian shoot-out behind migrant killing: police Four Lashkar-e-Taiba militants, who were behind the recent targeted killings of non-locals, were killed in an operation in south Kashmir’s Shopian on Thursday. U.S. FDA puts on hold Covaxin’s phase 2/3 clinical trials The U.S. Food and Drug Administration has put on hold the phase 2/3 clinical trials of Bharat Biotech’s …

WHO suspends UN supply of Covaxin over manufacturing deficiencies, Bharat Biotech slows down production
2 years, 8 months ago

WHO suspends UN supply of Covaxin over manufacturing deficiencies, Bharat Biotech slows down production

India Today  

In a setback to India’s indigenous vaccine against Covid-19, the World Health Organisation has issued a statement saying that the body is suspending the supply of Bharat Biotech’s Covaxin through UN agencies. A day earlier, Bharat Biotech issued a statement saying the company “announces the temporary slowing down of production of Covaxin across its manufacturing facilities, having completed its supply …

Bharat Biotech says upgrading Covaxin facilities as WHO suspends vaccine supplies
2 years, 8 months ago

Bharat Biotech says upgrading Covaxin facilities as WHO suspends vaccine supplies

India TV News  

Highlights The WHO has suspended the supply of Covaxin vaccine under the United Nations procurement The development comes after an inspection of the COVID-19 vaccine last month Earlier too, Bharat Biotech had said it is working on further improvements and upgrades Bharat Biotech has said it is working on upgrades to ensure that the production of Covaxin continues to meet …

WHO pauses Covaxin supply via UN bodies
2 years, 8 months ago

WHO pauses Covaxin supply via UN bodies

The Hindu  

Bharat Biotech to upgrade facility The World Health Organisation on Saturday suspended supply of Bharat Biotech’s COVID vaccine, Covaxin, to allow the manufacturer to upgrade facilities and address deficiencies found during an inspection last month. ‘Will meet standards’ In a statement issued on April 1, Bharat Biotech said it was fully committed to implementing facility improvements and upgrades to ensure …

WHO suspends Covaxin supply to UN agencies
2 years, 8 months ago

WHO suspends Covaxin supply to UN agencies

Deccan Chronicle  

Hyderabad: The World Health Organization has confirmed it has suspended the supply of Covaxin, produced by city-based Bharat Biotech, through UN procurement agencies and recommending to countries that received the covid vaccine to take actions as appropriate. A statement issued by WHO on Saturday said the suspension is in response to the outcomes of its post EUL inspection held between …

WHO suspends international supply of Covaxin via UN procurement
2 years, 8 months ago

WHO suspends international supply of Covaxin via UN procurement

India Today  

The World Health Organization in a statement issued on April 2 confirmed the suspension of supply of Covaxin produced by Bharat Biotech, through UN procurement agencies and gave recommendation to the countries that received the vaccine to take actions as appropriate. On April 1, the Indian vaccine manufacturer Bharat Biotech issued a statement announcing the “temporary slowing down of Covaxin …

Bharat Biotech temporarily slows down Covaxin production for facility optimisation
2 years, 8 months ago

Bharat Biotech temporarily slows down Covaxin production for facility optimisation

India Today  

Bharat Biotech on Friday announced it was temporarily slowing down production of its Covid-19 vaccine, Covaxin, across its manufacturing facilities for facility optimisation as it had already completed its supply obligations to procurement agencies and foresaw a decrease in demand. "For the coming period, the company will focus on pending facility maintenance, process, and facility optimisation activities," Bharat Biotech said …

Bharat Biotech says slowing down Covaxin production for facility optimisation
2 years, 8 months ago

Bharat Biotech says slowing down Covaxin production for facility optimisation

India TV News  

Highlights Bharat Biotech said it is temporarily slowing down production of its COVID-19 vaccine Covaxin. Company said 'will focus on pending facility maintenance, process, facility optimisation activities' Bharat Biotech on Friday said it is temporarily slowing down production of its COVID-19 vaccine Covaxin across its manufacturing units for facility optimisation as it has already completed its supply obligations to procurement …

India's drugs regulator approves phase-3 trial of covid vaccine covovax
2 years, 9 months ago

India's drugs regulator approves phase-3 trial of covid vaccine covovax

India Today  

The Drugs Controller General of India granted permission on Wednesday for conducting the phase-3 clinical trial of Covid-19 vaccine Covovax as a booster dose in adults, official sources said. The Subject Expert Committee on Covid-19 of the Central Drugs Standard Control Organisation had, on March 5, recommended permission for conducting the phase-3 clinical trial for Covovax as a booster dose …

Bharat Biotech, SII Oppose Plea In Supreme Court For Public Disclosure Of Vaccine Trial Data
2 years, 9 months ago

Bharat Biotech, SII Oppose Plea In Supreme Court For Public Disclosure Of Vaccine Trial Data

Live Law  

Vaccine manufactures Bharat Biotech Ltd and Serum Institute of India opposed a petition in the Supreme Court seeking disclosure of the data on clinical trial and adverse events following immunization in relation to Covaxin and Covishield vaccines developed by them respectively against COVID-19 pandemic.A bench comprising Justices L Nageswara Rao and BR Gavai was hearing a writ petition filed. Vaccine …

DCGI Grants Emergency Use Authorisation to SII's Covid Vaccine Covovax for 12-17 Age Group
2 years, 9 months ago

DCGI Grants Emergency Use Authorisation to SII's Covid Vaccine Covovax for 12-17 Age Group

News 18  

India’s central drug regulator on Wednesday granted emergency use authorisation to Serum Institute of India’s Covid-19 vaccine Covovax for the 12-17 age group subject to certain conditions. Confirming the 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 …

Govt Panel Recommends Permission for Phase-3 Trial of Covovax as Booster Dose in Adults
2 years, 9 months ago

Govt Panel Recommends Permission for Phase-3 Trial of Covovax as Booster Dose in Adults

News 18  

An expert panel of India’s central drug authority has recommended permission for conducting a phase-3 clinical trial of Covid vaccine Covovax as a booster dose in adults, official sources said on Sunday. The Subject Expert Committee on COVID-19 of the Central Drugs Standard Control Organisation had on Friday recommended giving permission for conducting a phase-3 clinical trial of the single-dose …

DCGI grants restricted EUA to COVID jab Corbevax for 12-18 age group
2 years, 10 months ago

DCGI grants restricted EUA to COVID jab Corbevax for 12-18 age group

Deccan Chronicle  

New Delhi/Hyderabad: The Drugs Controller General of India has granted restricted emergency use authorisation to Biological E's COVID-19 vaccine Corbevax for the 12 to 18 years age group, subject to certain conditions, official sources said on Monday. The DCGI's approval comes after the Subject Expert Committee on COVID-19 of the CDSCO on February 14 recommended granting restricted EUA to Corbevax …

US to evaluate Covaxin as COVID-19 vaccine candidate, announces Bharat Biotech
2 years, 10 months ago

US to evaluate Covaxin as COVID-19 vaccine candidate, announces Bharat Biotech

Firstpost  

The FDA has lifted its clinical hold on Bharat Biotech’s Investigational New Drug application to evaluate the COVID-19 vaccine candidate, BBV152, known as Covaxin outside the United States Hyderabad: Hyderabad-based Bharat Biotech on Saturday said its COVID-19 vaccine Covaxin will be evaluated as a vaccine candidate for the disease in the United States. “Ocugen, Inc announced that the US Food …

Covaxin to be evaluated as COVID-19 vaccine candidate in US, says Bharat Biotech
2 years, 10 months ago

Covaxin to be evaluated as COVID-19 vaccine candidate in US, says Bharat Biotech

India TV News  

Highlights Covaxin will be evaluated as a COVID-19 vaccine candidate in United States, Bharat Biotech said. COVAXIN will be evaluated as a COVID-19 vaccine candidate in the United States, said Bharat Biotech on Saturday. In a statement, Ocugen Inc, Bharat Biotech's partner in the US and Canada for Covaxin, noted that the American health regulator -- the US Food and …

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