Excitement in some, disappointment in others: A peek into Covaxin phase 3 trial centres
3 years, 11 months ago

Excitement in some, disappointment in others: A peek into Covaxin phase 3 trial centres

India Today  

Three different cities, three different scenarios on Covaxin phase 3 trials! In Mumbai, doctors are finding it hard to convince people for the second dose; in Patna, more people have registered for clinical trials compared to phase 1 and phase 2; and in Jaipur, long lines of exuberant candidates are witnessed outside trial centres. 1,200 HUMAN TRIAL VOLUNTEERS AT PATNA AIIMS More than 1,200 volunteers have already received their first shot of the 0.5-ml intramuscular injection in the last phase of human trials at Patna AIIMS. Dr Chandra Mani Singh, medical superintendent of Patna AIIMS, said clinical trials of Covaxin began on December 7, and in the last four weeks, approximately 1,200 participants have been administered the vaccine. Dr CM Singh, who is also the principal investigator of the clinical trial, said, "Some 1,200 people have so far volunteered for the third phase of trial at Patna AIIMS.

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History of this topic

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 - …

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 …

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 …

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 …

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 …

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 …

Weighing the choices: on precautionary vaccine doses
2 years, 8 months ago

Weighing the choices: on precautionary vaccine doses

The Hindu  

As India sees a steady slump in its daily coronavirus count, the Centre has announced opening up the third, or ‘precautionary doses’, to everyone over 18 years. A major aspect of vaccines is the risk of adverse events following vaccination, and previous experience has suggested that certain vaccines may induce a higher risk of blood clots in younger populations. With …

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 …

ICMR Study Has Shown Rise in Antibodies Post Covaxin Booster Dose: MoS Health Tells Rajya Sabha
2 years, 8 months ago

ICMR Study Has Shown Rise in Antibodies Post Covaxin Booster Dose: MoS Health Tells Rajya Sabha

News 18  

An ICMR study to examine the effect of Covaxin's booster dose has shown an increase in the levels of antibodies against SARS-CoV-2, Minister of State for Health Bharati Pravin Pawar told the Rajya Sabha on Tuesday. International data available on booster doses of AstraZeneca and Covishield suggests a three- to four-fold increase in antibody levels after their administration, Pawar said …

Why India's vaccine advisory body recommends reducing second-dose gap for Covishield
2 years, 9 months ago

Why India's vaccine advisory body recommends reducing second-dose gap for Covishield

Firstpost  

The National Technical Advisory Group on Immunisation has recommended that the gap between the first and second dose of Covishield should be reduced to eight to 16 weeks, from the current gap of 12 to 16 The National Technical Advisory Group on Immunisation has recommended that the gap between the first and second dose of Covishield should be reduced to …

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 …

Covishield, Covaxin get sale approval in India
2 years, 10 months ago

Covishield, Covaxin get sale approval in India

Deccan Chronicle  

New Delhi: The Drugs Controller-General of India on Thursday granted regular market approval for the Serum Institute of India’s Covishield and Bharat Biotech’s Covaxin for use in the adult population subject to conditions. As Covid-19 infections, driven by the Omicron variant, are still raging, with 407 districts reporting a positivity rate of over 10 per cent, the Centre on Thursday …

Bharat Biotech gets approval for intranasal Covid-19 booster dose trials
2 years, 10 months ago

Bharat Biotech gets approval for intranasal Covid-19 booster dose trials

India TV News  

Highlights Intranasal vaccine will be administered to those who have already taken their two-dose vaccine The interval between the second dose of Covid vaccine and booster dose will be six months According to Bharat Biotech, its nasal vaccine stimulates immune responses at the site of infection The Drugs Controller General of India has granted permission to Hyderabad-based biotechnology firm Bharat …

Panel pitches full market nod for Covaxin, Covishield
2 years, 11 months ago

Panel pitches full market nod for Covaxin, Covishield

Hindustan Times  

The subject expert panel of the national drugs regulator on Wednesday recommended full market authorisation for both Covaxin and Covishield under certain conditions, according to people familiar with the developments. Serum Institute of India and Bharat Biotech International Ltd, manufacturers of Covishield and Covaxin respectively, separately applied to the central drugs standard control organisation to seek full market authorisation stating …

SEC recommends Covaxin, Covishield for full market authorisation: Report
2 years, 11 months ago

SEC recommends Covaxin, Covishield for full market authorisation: Report

Hindustan Times  

The subject expert committee of the Central Drugs Standard Control Organisation on Wednesday recommended regular market approval for Covaxin and Covishield, the two most widely used jabs in the national vaccination drive against Covid-19, news agency PTI has reported, citing official sources. The development comes just days after the SEC, on January 14, sought more data from the two manufacturers--Hyderabad-based …

Bharat Biotech again urges health workers to be ‘highly vigilant’ while jabbing teenagers
2 years, 11 months ago

Bharat Biotech again urges health workers to be ‘highly vigilant’ while jabbing teenagers

Hindustan Times  

Hyderabad-based Bharat Biotech International Limited on Tuesday urged healthcare workers to be ‘highly vigilant’ while administering jabs to teenagers aged 15 to 18, citing what it said were ‘additional reports’ stating that beneficiaries in the said age group were being jabbed with ‘unapproved Covid-19 vaccines.’ A medic administers Covid vaccine to a teen in Ludhiana at the civil surgeon’s office. …

Maharashtra faces shortage of Covaxin
2 years, 11 months ago

Maharashtra faces shortage of Covaxin

The Hindu  

Maharashtra is facing a shortage of Covaxin, which has been prescribed for the 15-18 age group by the Central government. Chief Minister Uddhav Thackeray will be placing the State’s demand for 40 lakh more doses to Prime Minister Narendra Modi at a videoconference on Thursday. The State government has also clarified that restrictions implemented are unlikely to be lifted before …

Holds promise: ICMR on trial results of third dose of Covaxin
2 years, 11 months ago

Holds promise: ICMR on trial results of third dose of Covaxin

Hindustan Times  

A day after Bharat Biotech released the trial results of the safety and immunogenicity of its Covid-19 vaccine ‘Covaxin’ as a booster shot, the Indian Council of Medical Research on Sunday affirmed the findings. Prime Minister Narendra Modi, in a televised address on December 25, 2021, announced precaution doses for healthcare and frontline workers from January 10 and Covid-19 jabs …

Covaxin booster shot may provide long-term immunity against severe Covid, says Bharat Biotech
2 years, 11 months ago

Covaxin booster shot may provide long-term immunity against severe Covid, says Bharat Biotech

India Today  

A booster dose of Bharat Biotech's Covid-19 vaccine Covaxin, administered six months after the second dose, could provide long-term immunity from severe SARS-CoV-2 infection, a study by Bharat Biotech and the Indian Council of Medical Research - National Institute of Virology, Pune, has indicated. The study, published on medRxiv and not yet peer-reviewed, said that the Covaxin booster shot is …

SEC approval for Bharat Biotech\'s COVID booster intranasal vaccine phase 3 trials
2 years, 11 months ago

SEC approval for Bharat Biotech\'s COVID booster intranasal vaccine phase 3 trials

Deccan Chronicle  

New Delhi: The Subject Experts Committee of the Drug Controller General of India on Wednesday granted approval to Bharat Biotech for conducting intranasal phase 3 trials and heterologous trials for COVID-19 booster intranasal vaccine for those who have taken both the doses of Covaxin and Covishield. "After detailed deliberation, the SEC 'in principle' agreed for the conduct of both phase …

SEC Recommends Bharat Biotech to Conduct Late-stage Trials, Submit Booster Protocol
2 years, 11 months ago

SEC Recommends Bharat Biotech to Conduct Late-stage Trials, Submit Booster Protocol

News 18  

The Subject Expert Committee of India’s drug authority has recommended Bharat Biotech to conduct late-stage trials for its intranasal vaccine BBV154. After discussions and deliberations for almost five hours on Tuesday, the expert panel has asked Bharat Biotech to add a Covishield arm in the booster trails and submit a protocol for the same. Bharat Biotech will submit a revised …

SEC Meet to Discuss Bharat Biotech’s Nasal Vaccine as Booster for Those Jabbed with Covishield, Covaxin
2 years, 11 months ago

SEC Meet to Discuss Bharat Biotech’s Nasal Vaccine as Booster for Those Jabbed with Covishield, Covaxin

News 18  

The Subject Expert Committee of India’s drug authority is set to meet to examine Bharat Biotech’s application for its intranasal Covid vaccine as a booster or a third dose, CNN-News18 has learnt. In its application, the company has proposed to use its intranasal vaccine BBV154 as a heterologous booster dose in already vaccinated individuals, who have received two doses of …

AP teenagers to start getting jabs from today
2 years, 11 months ago

AP teenagers to start getting jabs from today

Deccan Chronicle  

VIIJAYAWADA: Teenagers in the 15-18 years age-group will start getting Covid vaccination doses across the state from Monday. She said booster doses would be given to healthcare and frontline workers who had taken the second dose at least 39 weeks before January 10. Health and family welfare state commissioner Katamneni Bhaskar said that nearly 19 lakh ANMs would administer the …

\'Precaution dose\' vaccine: NTAGI to decide next week
2 years, 11 months ago

\'Precaution dose\' vaccine: NTAGI to decide next week

Deccan Chronicle  

New Delhi: Amid a sharp rise in Covid-19 cases across the country, the National Technical Advisory Group on Immunisation and its working group will meet next week to finalise which vaccine will be given as a “precautionary” dose to healthcare and frontline workers and senior citizens above 60 with co-morbidities from January 10. The order issued by DCP S. Chaitanya …

60+ to Get 3rd Dose 9 Months After 2nd Shot, Kids to Get Covaxin Only, Centre Says in New Guidelines
2 years, 11 months ago

60+ to Get 3rd Dose 9 Months After 2nd Shot, Kids to Get Covaxin Only, Centre Says in New Guidelines

News 18  

The Union Health Ministry on Monday issued guidelines for Covid-19 vaccination of children aged between 15-18 years and precaution dose to healthcare and frontline workers, and those above the age of 60 with comorbidities. The guidelines comes, two days after Prime Minister Narendra Modi announced on Saturday that vaccination for children between 15-18 years will start from January 3, while …

Only Covaxin for young adults, 39-week gap for precaution doses: Here's more
2 years, 11 months ago

Only Covaxin for young adults, 39-week gap for precaution doses: Here's more

Hindustan Times  

As the country expands its vaccination programme against Covid-19, the Union ministry of health and family welfare on Monday issued a fresh set of guidelines on the registration and inoculation drive that will cover children between 15 and 18 years of age, besides administration of ‘precaution doses’ for healthcare and frontline workers and those above 60 years of age with …

Bharat Biotech Seeks DCGI Nod for Trials to Evaluate Efficacy of Covaxin Booster Shot - News18
2 years, 11 months ago

Bharat Biotech Seeks DCGI Nod for Trials to Evaluate Efficacy of Covaxin Booster Shot - News18

News 18  

Bharat Biotech has sought permission from India’s drug regulator to conduct clinical trials for evaluating the efficacy of a third dose of its Covid-19 vaccine, Covaxin. According to a top government official, the indigenous vaccine maker has proposed to conduct clinical trials for Covaxin’s booster shot on 5,000 healthy volunteers, keeping a gap of six months between the second and …

Covaxin cleared for those above 12
2 years, 11 months ago

Covaxin cleared for those above 12

The Hindu  

Covaxin has been approved for use in those aged 12 and above by the Drugs Controller General of India. The DCGI in August granted emergency approval to Zycov-D, a three-dose, DNA COVID-19 vaccine developed by the Ahmedabad-based Zydus Cadilla Group, making it the first vaccine in India that could be administered to adults and those 12 and above. Welcoming the …

Bharat Biotech to donate 2 lakh doses of covaxin to Vietnam
3 years ago

Bharat Biotech to donate 2 lakh doses of covaxin to Vietnam

Live Mint  

Bharat Biotech will donate 2,00,000 doses of covaxin to The Republic of Vietnam, the Hyderabad based pharmaceutical company said on Thursday. This donation represents a gesture of goodwill to provide access to Bharat Biotech World Health Organization approved, indigenously developed covaxin to fight the covid-19 pandemic across borders, Suchitra Ella, Joint Managing Director of Bharat Biotech said. Bharat Biotech was …

Covaxin shows 50% effectiveness against symptomatic Covid-19, says Lancet study
3 years, 1 month ago

Covaxin shows 50% effectiveness against symptomatic Covid-19, says Lancet study

India Today  

Two doses of Covaxin are 50 per cent effective against the symptomatic disease, according to the first real-world assessment of India's indigenous Covid-19 vaccine published in The Lancet Infectious Diseases journal. Results of an interim study recently published in The Lancet showed that two doses of Covaxin, also known as BBV152, had 77.8 per cent efficacy against symptomatic disease and …

How Macaulay Putras Ridiculed Covaxin and Data Proved Them Wrong
3 years, 1 month ago

How Macaulay Putras Ridiculed Covaxin and Data Proved Them Wrong

News 18  

The Phase III human clinical trials of Covaxin began in mid-November 2020, involving 26,000 volunteers, between 18 and 98 years of age, across 21 sites. It was India’s first and only Phase III study for a COVID-19 vaccine, and the largest Phase III efficacy trial ever conducted here for any vaccine. He said that if the East India Company had …

Bharat Biotech's Covaxin phase 3 data shows 77.8 pc efficacy against COVID, says Lancet
3 years, 1 month ago

Bharat Biotech's Covaxin phase 3 data shows 77.8 pc efficacy against COVID, says Lancet

India TV News  

Hyderabad-based Bharat Biotech on Friday announced that the Lancet peer-review confirmed the efficacy analysis of Bharat Biotech's Covaxin. "COVAXIN is the only COVID-19 vaccine to have demonstrated efficacy data from phase III clinical trials against the delta variant at 65.2 per cent," the official statement issued by Bharat Biotech said citing the study by the Lancet. "Efficacy analysis demonstrates Covaxin …

Covaxin Maker Bats for Booster Shots in India, Says Ideal After 6 Months of 2nd Dose
3 years, 1 month ago

Covaxin Maker Bats for Booster Shots in India, Says Ideal After 6 Months of 2nd Dose

News 18  

After several countries have begun inoculating the vulnerable population with booster shots against Covid-19, Covaxin manufacturer- Bharat Biotech CMD Krishna Ella said that a booster dose would be ideal six months after receiving the second dose of the anti-Covid vaccine. Taking about the delay in granting the EUA by the World Health Organisation for Covaxin, Ella blamed the “negative campaign” …

'Let's Wait For WHO Decision On COVAXIN' : Supreme Court Adjourns Plea For Re-Vaccination Option
3 years, 1 month ago

'Let's Wait For WHO Decision On COVAXIN' : Supreme Court Adjourns Plea For Re-Vaccination Option

Live Law  

The Supreme Court on Friday posted for after the Diwali vacation a PIL seeking that in view of COVAXIN not having received WHO approval, individuals who have received COVAXIN shots to be re-vaccinated with COVISHIELD. The petition prays for directions to the UOI, Directorate General of Health Services, ICMR and Bharat Biotech to 'not restrain those who voluntarily, at their …

Second dose of Covid vaccine overdue for over 11 crore people: Govt data
3 years, 1 month ago

Second dose of Covid vaccine overdue for over 11 crore people: Govt data

Live Mint  

Over 11 crore people who have taken the first shot of COVID-19 vaccine have not got themselves jabbed with the second dose even after the expiry of the prescribed interval between two doses, according to government data. The data showed that over 3.92 crore beneficiaries are more than six weeks overdue for their second dose, around 1.57 crore are up …

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 …

No Nod for Covaxin Yet as WHO Seeks More Data, Final Assessment Likely on November 3
3 years, 1 month ago

No Nod for Covaxin Yet as WHO Seeks More Data, Final Assessment Likely on November 3

News 18  

The World Health Organization on Tuesday once again postponed granting approval to India’s indigenous Covid-19 vaccine Covaxin, seeking more technical details to conduct a final ‘risk-benefit assessment’. The global body — which was reviewing data on India’s Covaxin shot against Covid-19 to grant Emergency Use Listing — has sought additional information from Hyderabad-based Bharat Biotech to conduct a final “risk-benefit …

11 crore people skipped second dose of Covid-19 vaccine, shows govt data
3 years, 1 month ago

11 crore people skipped second dose of Covid-19 vaccine, shows govt data

India Today  

Over 11 crore people who have taken the first shot of Covid-19 vaccine have not got themselves jabbed with the second dose even after the expiry of the prescribed interval between two doses, according to government data. The data showed that over 3.92 crore beneficiaries are more than six weeks overdue for their second dose, around 1.57 crore are up …

WHO delays Covaxin approval, seeks additional clarifications from Bharat Biotech
3 years, 1 month ago

WHO delays Covaxin approval, seeks additional clarifications from Bharat Biotech

India TV News  

The World Health Organisation’s technical advisory group on Tuesday sought "additional clarifications" from Bharat Biotech for its COVID-19 vaccine Covaxin to conduct a final “risk-benefit assessment” for Emergency Use Listing of the vaccine. The technical advisory group met on Tuesday to review data on Covaxin for the emergency use listing of India’s indigenously-made vaccine. "The TAG met today and decided …

WHO Reviewing Data on Bharat Biotech’s Covaxin, Decision on Approval in '24 Hours or So'
3 years, 1 month ago

WHO Reviewing Data on Bharat Biotech’s Covaxin, Decision on Approval in '24 Hours or So'

News 18  

The World Health Organization was reviewing data on Covaxin, India’s indigenously-made vaccine against Covid-19 and will announce a decision on its Emergency Use Listing in “24 hours or so” a spokesperson said. WHO Chief Scientist Soumya Swaminathan had said in a tweet earlier that the technical advisory group at the organisation will meet on October 26 to consider the much-coveted …

‘Aware People Are Waiting, But…': WHO Explains Delay in Nod to Covaxin for Emergency Use
3 years, 2 months ago

‘Aware People Are Waiting, But…': WHO Explains Delay in Nod to Covaxin for Emergency Use

News 18  

The World Health Organization on Monday said it is “expecting one additional piece of information” from Bharat Biotech before it thoroughly evaluates COVAXIN for it to be included in the COVID-19 Emergency Use Listing. Covaxin manufacturer, Bharat Biotech, has been submitting data to WHO on a rolling basis and experts have been reviewing them, it said in a series of …

Biological E seeks DCGI’s nod for phase-3 trial of Corbevax as booster dose in those vaccinated with Covishield or Covax
3 years, 2 months ago

Biological E seeks DCGI’s nod for phase-3 trial of Corbevax as booster dose in those vaccinated with Covishield or Covax

Live Mint  

Hyderabad-based pharmaceutical company Biological E has sought permission from India's drug regulator to conduct the phase-3 clinical trial for its COVID-19 vaccine Corbevax as a single booster dose for those who have been fully vaccinated with Covishield or Covaxin. The company, meanwhile, has put in an application seeking the nod of the Drugs Controller General of India to conduct the …

Expert Committee recommends Covaxin for children, DCGI nod awaited
3 years, 2 months ago

Expert Committee recommends Covaxin for children, DCGI nod awaited

Deccan Chronicle  

HYDERABAD: The Subject Expert Committee on Covid-19 has recommended that the Drugs Controller General of India grant emergency use authorisation for Bharat Biotech’s Covaxin for children in the age group of two to 18 years, who constitute 41 per cent of the population. It noted that the data of the trials conducted on over 1,000 children across the country showed …

SEC to Take a Call on Paediatric Covaxin Today, Pre-filled Syringe to be Used for Children - News18
3 years, 2 months ago

SEC to Take a Call on Paediatric Covaxin Today, Pre-filled Syringe to be Used for Children - News18

News 18  

The Subject Expert Committee of the Central Drugs Standard Control Organization will take a call on Bharat Biotech’s paediatric Covid-19 vaccine on Monday. Pre-filled Syringe Vaccine Unlike the Covaxin for adults and other Covid-19 vaccines currently being administered that are available in multi-dose vials, the paediatric Covaxin will use a pre-filled syringe or PFS mechanism. In the case of children …

Bharat Biotech Submits Clinical Trial Data of Covaxin in Children to CDSC
3 years, 2 months ago

Bharat Biotech Submits Clinical Trial Data of Covaxin in Children to CDSC

News 18  

Bharat Biotech, which completed the Phase 2/3 trials of COVID-19 vaccine Covaxin for use in children under 18 years of age, has submitted the data to the Central Drugs Standard Control Organisation for its verification and subsequent approval for Emergency Use Authorisation for the jab, company sources said on Wednesday. ?Covaxin clinical trial data of 2-18 years age group has …

WHO decision on Bharat Biotech's Covaxin emergency use listing likely next week
3 years, 2 months ago

WHO decision on Bharat Biotech's Covaxin emergency use listing likely next week

Firstpost  

The Strategic Advisory Group of Experts on Immunization of the WHO met on Tuesday to make its recommendations on Covaxin on EUL, among other issues New Delhi: The WHO will take a call on granting Emergency Use Listing status for Bharat Biotech’s COVID-19 vaccine Covaxin next week, the global health body said on Tuesday. “WHO and an independent group of …

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