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The interim results of a Phase 3 study of Covaxin, an Indian vaccine developed by Bharat Biotech and the Indian Council of Medical Research, were peer-reviewed and published in The Lancet journal on Friday. According to the study, two doses of the vaccine provide 77.8% protection against symptomatic Covid. The efficacy data was disclosed by Bharat Biotech in a statement in July, but the studies’ results were not published in a peer-reviewed publication.
According to the Lancet study, the vaccination produces a strong antibody response. There were no serious vaccine-related adverse events or deaths among the trial participants. The bulk of the side effects, such as headaches, weariness, fever, and injection site soreness, were minor and occurred within seven days following immunization.
]]>https://theedgemedia.in/as-per-a-peer-reviewed-lancet-study-the-efficacy-of-covaxin-is-77-8/feed0According to a WHO official, Bharat Biotech’s Covid vaccine could be approved “within the next 24 hours”
https://theedgemedia.in/according-to-a-who-official-bharat-biotechs-covid-vaccine-could-be-approved-within-the-next-24-hours
https://theedgemedia.in/according-to-a-who-official-bharat-biotechs-covid-vaccine-could-be-approved-within-the-next-24-hours#respondTue, 26 Oct 2021 16:15:31 +0000https://theedgemedia.in/?p=24547According to Reuters, a technical committee of the World Health Organization (WHO) will assess the India-made Covaxin shot for approval today, citing a WHO official. The representative went on to say that he expects the WHO to issue a recommendation on the usage of Covaxin within the next 24 hours. “If all is in […]
]]>According to Reuters, a technical committee of the World Health Organization (WHO) will assess the India-made Covaxin shot for approval today, citing a WHO official. The representative went on to say that he expects the WHO to issue a recommendation on the usage of Covaxin within the next 24 hours.
“If all is in place and all goes well and if the committee is satisfied, we would expect a recommendation within the next 24 hours or so,” Margaret Harris told journalists at a UN press briefing.
On April 19, Bharat Biotech, based in Hyderabad, submitted an EOI (Expression of Interest) to the WHO for the vaccine’s Emergency Use Listing (EUL).
]]>https://theedgemedia.in/according-to-a-who-official-bharat-biotechs-covid-vaccine-could-be-approved-within-the-next-24-hours/feed0In authorizing India’s Covaxin injection, the WHO said it “cannot take corners”
https://theedgemedia.in/in-authorizing-indias-covaxin-injection-the-who-said-it-cannot-take-corners
https://theedgemedia.in/in-authorizing-indias-covaxin-injection-the-who-said-it-cannot-take-corners#respondMon, 18 Oct 2021 18:05:10 +0000https://theedgemedia.in/?p=24391The World Health Organization requested further information from India’s Bharat Biotech on Monday to examine the company’s request for an emergency-use designation for its COVID-19 injection, stating that the WHO could not “take shortcuts” in making a judgment. Bharat Biotech, which collaborated with an Indian governmental research entity to produce Covaxin, began sharing data […]
]]>The World Health Organization requested further information from India’s Bharat Biotech on Monday to examine the company’s request for an emergency-use designation for its COVID-19 injection, stating that the WHO could not “take shortcuts” in making a judgment.
Bharat Biotech, which collaborated with an Indian governmental research entity to produce Covaxin, began sharing data with the WHO in early July. Even before the end of a late-stage trial, which found the vaccination to be 78 percent effective, the vaccine was given emergency use authorization in India in January.
]]>https://theedgemedia.in/in-authorizing-indias-covaxin-injection-the-who-said-it-cannot-take-corners/feed0Bharat Biotech Put A Stop To Brazilian Agreement Of Vaccine Supply
https://theedgemedia.in/bharat-biotech-put-a-stop-to-brazilian-agreement-of-vaccine-supply
https://theedgemedia.in/bharat-biotech-put-a-stop-to-brazilian-agreement-of-vaccine-supply#respondFri, 23 Jul 2021 16:08:46 +0000https://theedgemedia.in/?p=19558Bharat Biotech announced on Friday that it has terminated its Memorandum of Understanding with Precisa Medicamentos and Envixia Pharmaceuticals LLC for its COVID-19 immunization Covaxin for the Brazilian market. The agreement was terminated when a deal with the Brazilian government for the delivery of 20 million doses of the vaccines faced criticism and prompted an […]
]]>Bharat Biotech announced on Friday that it has terminated its Memorandum of Understanding with Precisa Medicamentos and Envixia Pharmaceuticals LLC for its COVID-19 immunization Covaxin for the Brazilian market. The agreement was terminated when a deal with the Brazilian government for the delivery of 20 million doses of the vaccines faced criticism and prompted an inquiry by Brazilian regulators.
Precisa Medicamentos is Bharat Biotech’s Brazilian partner, assisting, guiding, and supporting the company with regulatory filings, licensing, sales, coverage, and the performance of phase III clinical studies, among other things.
According to the company, Bharat Biotech is pursuing licences in numerous nations based on the legal criteria of each country.
]]>https://theedgemedia.in/bharat-biotech-put-a-stop-to-brazilian-agreement-of-vaccine-supply/feed0Bharat Biotech To Supply 500M Covaxin Doses To Center
https://theedgemedia.in/bharat-biotech-to-supply-500m-covaxin-doses-to-center
https://theedgemedia.in/bharat-biotech-to-supply-500m-covaxin-doses-to-center#respondFri, 23 Jul 2021 15:57:12 +0000https://theedgemedia.in/?p=19555Bharat Biotech spoke on Friday that it has agreed to supply the Centre with approximately 500 million doses of its Covid-19 vaccine Covaxin as part of the nationwide vaccination campaign. Suchitra Ella, joint Managing Director of the metropolitan area vaccine producer, stated at a digital meeting held by the Confederation of Indian Industry that the […]
]]>Bharat Biotech spoke on Friday that it has agreed to supply the Centre with approximately 500 million doses of its Covid-19 vaccine Covaxin as part of the nationwide vaccination campaign. Suchitra Ella, joint Managing Director of the metropolitan area vaccine producer, stated at a digital meeting held by the Confederation of Indian Industry that the company’s operations in four cities – Hyderabad, Bengaluru, Pune, and Ankaleshwar – are now manufacturing Covaxin.
Bharati Pravin Pawar, Minister of State for Health, stated in Parliament on Tuesday that the Serum Institute of India furnished the Centre with 5.45 crore (54.5 million) doses of Covaxin by Bharat Biotech and 36.01 crores (360 million) doses of Covishield from January to July 16.
]]>https://theedgemedia.in/bharat-biotech-to-supply-500m-covaxin-doses-to-center/feed0Bharat Biotech Going To Have A Meeting With WHO Next Wednesday
https://theedgemedia.in/bharat-biotech-going-to-have-a-meeting-with-who-next-wednesday
https://theedgemedia.in/bharat-biotech-going-to-have-a-meeting-with-who-next-wednesday#respondThu, 17 Jun 2021 04:53:35 +0000https://theedgemedia.in/?p=15477After studying a WHO document, Hyderabad-based vaccine producer Bharat Biotech will have its pre-submission meet with the World Health Organization (WHO) next Wednesday, i.e. on June 23, requesting the authorization of Covaxin, its India-made Covid-19 vaccine. The pharma business has faced challenges in obtaining Covaxin authorized in some foreign nations because it lacks Phase-3 trial […]
]]>After studying a WHO document, Hyderabad-based vaccine producer Bharat Biotech will have its pre-submission meet with the World Health Organization (WHO) next Wednesday, i.e. on June 23, requesting the authorization of Covaxin, its India-made Covid-19 vaccine.
The pharma business has faced challenges in obtaining Covaxin authorized in some foreign nations because it lacks Phase-3 trial results, which is required for a WHO approval to ship the vaccine and include it in the much-coveted coronavirus “vaccine passport.”
Bharat Biotech previously informed ANI that Covaxin’s Phase-3 trial data would be made public in July, after which the firm would seek a full license of the Covid-19 vaccine in India.
]]>https://theedgemedia.in/bharat-biotech-going-to-have-a-meeting-with-who-next-wednesday/feed0New plant in Gujrat to ramp up Covaxin production by 200 million
https://theedgemedia.in/new-plant-in-gujrat-to-ramp-up-covaxin-production-by-200-million
https://theedgemedia.in/new-plant-in-gujrat-to-ramp-up-covaxin-production-by-200-million#respondThu, 20 May 2021 16:43:29 +0000https://theedgemedia.in/?p=13131Bharat Biotech on thursday, 20th May has said that they have ramped up the production of Covaxin. Chiron Behring, a subsidy of Bharat Biotech in Ankleshwar, Gujrat to produce 200 million doses of Covaxin per annum. This will take the Covaxin doses up to 1 billion per annum, according to the company. Earlier, Bharat Biotech […]
]]>Bharat Biotech on thursday, 20th May has said that they have ramped up the production of Covaxin. Chiron Behring, a subsidy of Bharat Biotech in Ankleshwar, Gujrat to produce 200 million doses of Covaxin per annum. This will take the Covaxin doses up to 1 billion per annum, according to the company.
Earlier, Bharat Biotech had deployed multiple production lines at its Hyderabad and Bengaluru campuses to meet the country’s growing need of vaccine. There was a drastic drop in the speed of the national vaccine drive due to depleted stocks of vaccine.
The company ramped up capacities at its own established campuses that are specialized in manufacturing inactivated viral vaccines under the highest levels of biosafety.
]]>https://theedgemedia.in/new-plant-in-gujrat-to-ramp-up-covaxin-production-by-200-million/feed0Nitin Gadkari says that more pharma companies should be allowed to make vaccine
https://theedgemedia.in/nitin-gadkari-says-that-more-pharma-companies-should-be-allowed-to-make-vaccine
https://theedgemedia.in/nitin-gadkari-says-that-more-pharma-companies-should-be-allowed-to-make-vaccine#respondTue, 18 May 2021 16:27:01 +0000https://theedgemedia.in/?p=12993The Union Minister Nitin Gadkari suggested that more pharma companies needs to be given permission for the production of Covid-19 vaccine. He made the suggestion in view of the shortage of the vaccine and to increase production. Mr. Gadkari said while addressing virtually to the Vice Chancellors of Universities that he will also request Prime […]
]]>The Union Minister Nitin Gadkari suggested that more pharma companies needs to be given permission for the production of Covid-19 vaccine. He made the suggestion in view of the shortage of the vaccine and to increase production.
Mr. Gadkari said while addressing virtually to the Vice Chancellors of Universities that he will also request Prime Minister Narendra Modi to bring a law that would allow more pharma companies to manufacture the life-saving vaccine.
He said,”If the demand of vaccine is more than its supply then it creates a problem. So, instead of one company, 10 more companies should be allowed to make vaccines by paying 10 per cent royalty to the original patent holder of the vaccine”.
At the recent time, there are only two companies that are producing the vaccine- Bharat Biotech and Serum Institute of India namely Covaxin and Covishield respectively.
]]>https://theedgemedia.in/nitin-gadkari-says-that-more-pharma-companies-should-be-allowed-to-make-vaccine/feed0Phase 2/3 trials of Covaxin in children to begin in 10-12 days
https://theedgemedia.in/phase-2-3-trials-of-covaxin-in-children-to-begin-in-10-12-days
https://theedgemedia.in/phase-2-3-trials-of-covaxin-in-children-to-begin-in-10-12-days#respondTue, 18 May 2021 14:17:44 +0000https://theedgemedia.in/?p=12968The senior NITI Aayog member, VK Paul announced on Tuesday that the phase II/III clinical trials will begin in 10-12 days. The trials will be for the children ageing between 2 to 18 years. The Health Ministry said that proposal was initiated in Subject Expert Committee (SEC) on May 11. India gave clearance to the […]
]]>The senior NITI Aayog member, VK Paul announced on Tuesday that the phase II/III clinical trials will begin in 10-12 days. The trials will be for the children ageing between 2 to 18 years. The Health Ministry said that proposal was initiated in Subject Expert Committee (SEC) on May 11. India gave clearance to the Covaxin trials on May 13.
Dr. VK Paul, a member of the health NITI Aayog said,”COVAXIN has been approved by the Drugs Controller General of India (DCGI), for phase II/III clinical trials in the age group of 2 to 18 years. I have been told that trials will begin in the next 10-12 days”. The trial will be done in 525 subjects at various sites.
Covaxin, together with Covishield, is being used to vaccinate adults in the country. The US authorized Pfizer and BioNTech’s vaccine for children ageing from 2 to 15 years last week.
]]>https://theedgemedia.in/phase-2-3-trials-of-covaxin-in-children-to-begin-in-10-12-days/feed0Results of first stage of Bharat Biotech covid-19 vaccine successful, no side effects shown
https://theedgemedia.in/result-of-first-stage-of-bharat-biotech-covid-19-vaccine
https://theedgemedia.in/result-of-first-stage-of-bharat-biotech-covid-19-vaccine#respondThu, 17 Dec 2020 04:20:27 +0000https://theedgemedia.in/?p=7473Bharat Biotech’s indigenous Corona vaccine ‘Kovaxine’ has shown better immune response in the first phase of clinical trials. No side effects of this vaccine have been seen during the trial. Interim results of the first phase of clinical trials have shown that no serious or adverse effects have been observed on all age groups. In […]
]]>Bharat Biotech’s indigenous Corona vaccine ‘Kovaxine’ has shown better immune response in the first phase of clinical trials. No side effects of this vaccine have been seen during the trial. Interim results of the first phase of clinical trials have shown that no serious or adverse effects have been observed on all age groups. In the foreign portal ‘MedRxIV’, it has been claimed that the vaccine is completely safe and effective. The first phase of clinical trial of this biotech of India biotech ended in September itself, the results of which have now been made public. The year 2020 is nearing its end and with this some positive news has started coming in the ongoing war against the corona virus. Interim results of the first stage clinical trial of the indigenous covid-19 vaccine ‘Kovaxin’ developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) showed no serious or adverse effects on all age groups. According to the result, ‘a serious case of adverse effect came up. The participant was given a vaccine dose on 30 July. Five days later, the symptoms of covid-19 were found in the patient and he was found infected with SARS-Cov 2. It says, ‘These were mild symptoms but the patient was admitted to the hospital on 15 August. The patient was discharged from the hospital on August 22 after the nucleic acid results were negative. This case was not associated with the vaccine. In order to test it, 375 volunteers were involved at different places in 11 hospitals.