Over 100 Experts from Friendly Nations Trained for Clinical Trials of Indian Covid-19 Vaccine: Official
4 years ago

Over 100 Experts from Friendly Nations Trained for Clinical Trials of Indian Covid-19 Vaccine: Official

News 18  

Over 100 experts from friendly neighbouring nations have so far been trained to strengthen capacities in their countries for facilitating phase-3 clinical trials of Indian COVID-19 vaccine, a senior official of the department of biotechnology said on Wednesday. Addressing a webinar organised by the Confederation of Indian Industry, Alka Sharma, an adviser with the Department of Biotechnology, said the partnership for advancing clinical trials initiative is being carried out in association with the external affairs ministry. "…The PACT is under the initiative of Department of Biotechnology and Ministry of External Affairs to strengthen capacities for facilitating phase-3 clinical trials of Indian COVID vaccine in friendly neighbouring countries," she said. Similarly, Dr Reddy's Laboratories is conducting phase 2 and 3 clinical trials for Russian vaccine Sputnik V, she said.

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History of this topic

Phase-3 clinical trial of India's first dengue vaccine begins at KIMS-Bhubaneswar
3 months, 3 weeks ago

Phase-3 clinical trial of India's first dengue vaccine begins at KIMS-Bhubaneswar

New Indian Express  

BHUBANESWAR: The phase-3 clinical trial for India's first Indigenous dengue vaccine, ‘DengiAll,’ commenced at the Kalinga Institute of Medical Sciences on Tuesday. This trial aims to evaluate the efficacy of the Indigenous tetravalent dengue vaccine developed by Panacea Biotec in collaboration with the Indian Council of Medical Research. The tetravalent dengue vaccine, originally developed by the National Institutes of Health, …

With State prod, India can be world leader in vaccines
10 months, 4 weeks ago

With State prod, India can be world leader in vaccines

Hindustan Times  

The World Health Organization activated its incident management support team as part of its emergency response framework on the emergence of a cluster of atypical pneumonia cases emerging from Wuhan, China, on January 1, 2020. India, the dark horse in the vaccine race, did the unexpected and against all odds, approving EUA to two vaccines — “made in India” Covishield …

How India’s Vaccine Industry Will Save Millions of Children in Africa - News18
1 year, 2 months ago

How India’s Vaccine Industry Will Save Millions of Children in Africa - News18

News 18  

On 2 October 2023, when India celebrated both Gandhi and Lal Bahadur Shastri Jayanti, there was one more reason to celebrate this year. In April 2023, almost coinciding with World Malaria Day, the West African nation Ghana approved the malaria vaccine R21, even before it was approved by the WHO. The vaccine R21 is developed at the University of Oxford …

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. …

India urges G-20 countries to join vaccine research collaborative in wake of COVID vaccine inequity
1 year, 6 months ago

India urges G-20 countries to join vaccine research collaborative in wake of COVID vaccine inequity

The Hindu  

With the COVID-19 pandemic exposing the acute inequity in vaccine development and access, the Indian government is working in partnership with two leading global non-profits to convene and build consensus among the G-20 member States and others, for a proposed Global Vaccine Research Collaborative. “International cooperation is essential to advance vaccine development for emerging pathogens, and the G-20 can serve …

Explained | What are the problems with India’s clinical trials registry?
1 year, 8 months ago

Explained | What are the problems with India’s clinical trials registry?

The Hindu  

The speedy approval of Covid-19 vaccines during the SARS-CoV-2 pandemic spotlighted the importance of clinical trials. Hosted with the Indian Council of Medical Research’s National Institute of Medical Statistics, the CTRI is a free, online public-record system to register clinical trials being conducted in India. The CTRI is one of 17 public trial registries under the International Clinical Trials Registry …

‘The Vial’ trailer out: Manoj Bajpayee narrates History TV18's documentary on India’s Covid-19 vaccine journey
1 year, 9 months ago

‘The Vial’ trailer out: Manoj Bajpayee narrates History TV18's documentary on India’s Covid-19 vaccine journey

Firstpost  

India’s Covid-19 vaccination programme has proven to be the world’s largest but how did the nation, led by Prime Minister Narendra Modi, embark on this journey? To find out the details of a historic and unprecedented battle, check out History TV18’s documentary titled ‘The Vial – India’s Vaccine Story’ on March 24, 2023, at 8PM. ‘The Vial’ brings to life …

COVID-19: 3 lakh doses of intranasal vaccine iNCOVACC sent to hospitals, says Bharat Biotech's Krishna Ella
1 year, 10 months ago

COVID-19: 3 lakh doses of intranasal vaccine iNCOVACC sent to hospitals, says Bharat Biotech's Krishna Ella

India TV News  

COVID-19 vaccine : Bharat Biotech dispatched three lakh doses of its intranasal COVID-19 vaccine to some hospitals two days ago, the company's executive chairman Krishna Ella said on Sunday. "We dispatched three lakh doses of the world's first intranasal COVID-19 vaccine to some hospitals two days ago," Ella said. Establishing the UW-Madison Global One Health Centre holds great significance as …

Bharat Biotech’s nasal vaccine likely to be launched on Jan 26
1 year, 11 months ago

Bharat Biotech’s nasal vaccine likely to be launched on Jan 26

Hindustan Times  

Bhopal: Bharat Biotech’s nasal Covid-19 vaccine iNCOVACC is expected to be launched on January 26, executive chairman Krishna Ella said at an event on Saturday. “Our nasal vaccine will be officially launched on January 26 on Republic Day,” Ella told students at the Maulana Azad National Institute of Technology in Bhopal, where the India International Science Festival, 2022, is being …

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 …

Oxford, Serum initiative: Anti-malaria vaccine’s Phase 3 trials conclude
2 years ago

Oxford, Serum initiative: Anti-malaria vaccine’s Phase 3 trials conclude

Hindustan Times  

Oxford University and the Serum Institute of India have completed Phase 3 trials for the R21 anti-malarial vaccine in Africa, company officials said on Monday. “Phase-3 trial for R21, which is a cost-effective multi-stage malaria vaccine, is completed in Africa,” said Umesh Shaligram, executive director of Serum Institute of India, on Monday. The makers said that the aim of the …

Will Two ‘Made-in-India’ Vaccines Be the New Covid Boosters? News18 Decodes Differences
2 years, 3 months ago

Will Two ‘Made-in-India’ Vaccines Be the New Covid Boosters? News18 Decodes Differences

News 18  

India will soon roll out mRNA shots and intranasal vaccines, which will be available on CoWIN, and can be used as boosters against Covid-19. India’s first mRNA shot is only the third mRNA vaccine to be approved for Covid-19 in the world after Pfizer and Moderna. But mortality will be reduced.” Sharing a study of the intranasal vaccines under clinical …

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, …

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 …

India to Participate in Global Trials to Assess Safety of Covishield among Cancer, HIV, Transplant Patients
2 years, 7 months ago

India to Participate in Global Trials to Assess Safety of Covishield among Cancer, HIV, Transplant Patients

News 18  

India will soon kick-start trials to assess the safety and immunity of AstraZeneca’s Covid-19 vaccine, dubbed Covishield in India, among unvaccinated immunocompromised adults, News18.com has learnt. According to the study planned on the global scale, previously unvaccinated immunocompromised adults will be enrolled in five disease cohorts — solid organ transplant, hematopoietic stem cell transplant, solid organ cancer patients receiving cytotoxic …

Nasal COVID-19 vaccine trials held at Vizag Institute
2 years, 8 months ago

Nasal COVID-19 vaccine trials held at Vizag Institute

Deccan Chronicle  

Visakhapatnam: The Visakha Institute of Medical Science hosted the third phase of the clinical trial of Covid-19 intranasal vaccine here on Saturday. VIMS is the only hospital in Andhra Pradesh among 17 locations in the country to have the trials of the Covid-19 nasal vaccine that is meant for people who have never got vaccinated so far. VIMS director Dr …

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 …

BRICS grouping should work together to support vaccine endeavours: Health Minister
2 years, 9 months ago

BRICS grouping should work together to support vaccine endeavours: Health Minister

The Hindu  

India, having one of the world’s largest vaccine manufacturing industries that supplied vaccines to more than 150 countries and met 65-70% of the World Health Organisation’s vaccine requirements, is willing to offer its robust vaccine manufacturing industry for developing vaccines for BRICS, as well as the world,” Union Health Minister Dr. Mansukh Mandaviya said on Tuesday while launching the BRICS …

Gennova Biopharmaceuticals submits Phase 2,3 trial data of India's first mRNA COVID vaccine to DCGI
2 years, 9 months ago

Gennova Biopharmaceuticals submits Phase 2,3 trial data of India's first mRNA COVID vaccine to DCGI

Firstpost  

The company has also developed an Omicron-specific vaccine which will be tested on humans for efficacy and immunogenicity New Delhi: Pune-based Gennova Biopharmaceuticals has submitted the phase-II and phase-III trials data of India’s first mRNA COVID vaccine to the regulator Drugs Controller General of India on Friday, said sources. “India is heading towards becoming a vaccine superpower and the fact …

Govt panel recommends permission for phase 3 trial of Sputnik Light vaccine as booster dose
2 years, 9 months ago

Govt panel recommends permission for phase 3 trial of Sputnik Light vaccine as booster dose

India Today  

An expert panel of India’s central drug authority has recommended permission to conduct a phase-3 clinical trial of the single-dose Covid-19 vaccine ‘Sputnik Light’ as a booster dose, official sources said on Saturday. "The Subject Expert Committee on Covid-19 of the Central Drugs Standard Control Organisation, which reviewed the application on Friday after detailed deliberation, recommended granting permission for the …

Covid-19 Vaccine Sputnik V's India Production In A Fix After Sanctions on Russia's Jab Manufacturer
2 years, 9 months ago

Covid-19 Vaccine Sputnik V's India Production In A Fix After Sanctions on Russia's Jab Manufacturer

News 18  

The sanctions imposed by the United States on the Russian Direct Investment Fund, which markets Sputnik V internationally has raised concerns over the manufacturing of the Covid-19 vaccine in India, the second largest producer of the jab after Russia. RDIF is Russia’s sovereign wealth fund established in 2011 to make equity co-investments, primarily in Russia, alongside reputable international financial and …

India’s first mRNA COVID-19 vaccine likely to be rolled out by April
2 years, 10 months ago

India’s first mRNA COVID-19 vaccine likely to be rolled out by April

The Hindu  

Data from human trials of India’s first homegrown mRNA COVID-19 vaccine are likely to be presented to authorities for evaluation by the end of the month, and company officials are aiming to roll out the product before April, two senior scientists connected to the Department of Biotechnology told The Hindu. The mRNA vaccine being developed by Pune-based Gennova Biopharmaceuticals is …

A dose of science in the vaccination strategy
2 years, 10 months ago

A dose of science in the vaccination strategy

The Hindu  

Six weeks after the Indian government announced ‘precaution shots’ or the ‘third dose’ of COVID-19 vaccines for select populations, there have been four relevant developments. Two, given that COVID-19 vaccines currently in use in India have limited evidence about their role in reducing transmission, nasal vaccines, through mucosal antibodies, are likely to perform better in reducing transmission. The role of …

Single-dose Sputnik Light Covid vaccine gets approval for emergency use in India
2 years, 10 months ago

Single-dose Sputnik Light Covid vaccine gets approval for emergency use in India

India Today  

The Drugs Controller General of India has granted emergency-use permission to the single-dose Sputnik Light COVID-19 vaccine on Sunday. DCGI has granted emergency use permission to Single-dose Sputnik Light COVID-19 vaccine in India. — Dr Mansukh Mandaviya February 6, 2022 An expert panel of India's central drug authority on Friday recommended granting restricted emergency use authorisation to the single-dose Covid-19 …

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 …

India's Gennova Biopharma developing Omicron-specific Covid vaccine: Sources
2 years, 11 months ago

India's Gennova Biopharma developing Omicron-specific Covid vaccine: Sources

India Today  

Gennova Biopharmaceuticals, a Pune-based company which is making India's first mRNA vaccine, has submitted phase-2 trial data of its mRNA Covid-19 vaccine. During his speech at the 76th United Nations General Assembly, Prime Minister Narendra Modi had earlier stated that India’s first mRNA vaccine was in the final stages. The vaccines developed using mRNA techniques teach our cells how to …

An epidemiologically sound testing strategy
2 years, 11 months ago

An epidemiologically sound testing strategy

The Hindu  

On January 10, 2022, the Indian Council of Medical Research released an Advisory on Purposive Testing Strategy for COVID-19 in India. The latest COVID-19 testing strategy replaces the previous advisory, released on September 4, 2020 and inter alia, had the provision of COVID-19 testing on demand for ‘all individuals who wish to get themselves tested’. India, following this approach, ramped …

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 …

Maximising the boost: The Hindu Editorial on mixing COVID-19 vaccines
2 years, 11 months ago

Maximising the boost: The Hindu Editorial on mixing COVID-19 vaccines

The Hindu  

Heralding a new frontier in India’s vaccination programme, the apex drug regulator has approved two more vaccines under emergency use authorisation, and an antiviral drug. Despite three vaccines being available, India has overwhelmingly been reliant on Covishield and that is a matter of concern as a new chapter in the vaccination programme unfolds. The new directives say that “precaution doses”, …

Biological E Gets Govt Go-ahead for Phase 3 Trials of Corbevax as Booster Dose
2 years, 11 months ago

Biological E Gets Govt Go-ahead for Phase 3 Trials of Corbevax as Booster Dose

News 18  

The Drug Controller General of India has given the nod for conducting phase 3 trials to test Biological E’s Covid vaccine Corbevax as booster shots, News18.com has learnt. “The company has been given the go-ahead to conduct phase 3 trials using Corbevax as a booster dose. The approvals have been given for conducting trials on those who will receive first …

Explained | How has India responded to SARS-CoV-2 variants?
2 years, 11 months ago

Explained | How has India responded to SARS-CoV-2 variants?

The Hindu  

The story so far : India began 2021 with the hope that cases would continue to decline as had been the trend from September 2020 and that the two vaccines would help stem the spread of COVID-19. On April 8, with daily cases close to a lakh and higher than it had ever been as per India’s official count, India …

Omicron: Parliamentary panel recommends evaluation of vaccines, more research for booster dose
3 years ago

Omicron: Parliamentary panel recommends evaluation of vaccines, more research for booster dose

The Hindu  

Amid growing concerns over the Omicron variant of SARS-CoV-2, a parliamentary committee has recommended that the efficacy of COVID-19 vaccines must be evaluated and the government conduct more research to examine the need for booster doses to contain the new strain. The Parliamentary Standing Committee on Health, which presented its report on Friday, also said that concerns with regard to …

Covid-19: J&J's Hyderabad-made Jabs Get CDL Nod, Over 1 Cr Doses Ready for Export
3 years, 1 month ago

Covid-19: J&J's Hyderabad-made Jabs Get CDL Nod, Over 1 Cr Doses Ready for Export

News 18  

American pharma giant Johnson & Johnson’s Covid-19 vaccine shots, manufactured in India by Hyderabad-based Biological E, are ready for export, News18.com learnt. “Once the Drug Controller General of India approves the report sent by CDL and the request filed by the company, the batches can be exported.” The move is in line with Prime Minister Narendra Modi’s announcement at the …

India to Start Clinical Trials of US-Based Second Generation, Low-Cost Covid-19 Vaccine
3 years, 1 month ago

India to Start Clinical Trials of US-Based Second Generation, Low-Cost Covid-19 Vaccine

News 18  

India will soon start clinical trials of US-based Akston Biosciences second-generation Covid-19 vaccine — one of the most promising candidates that can be rapidly produced at a low cost, suitable for repeated dosing if immunity wanes and requires no refrigeration. “The total sample size from Indian trial is around 1,600 people under phase2/phase 3 trials, which take at least a …

Serum Institute seeks DCGI nod for Covid vaccine Covovax
3 years, 1 month ago

Serum Institute seeks DCGI nod for Covid vaccine Covovax

India Today  

The Serum Institute of India on Friday sought permission from the Drugs Controller General of India to manufacture Covid-19 vaccine Covovax for restricted use in emergency situations at its Manjari manufacturing site, official sources said. There were no safety concerns arising from the study data and Covovax is safe and immunogenic in the adult population, Prakash Kumar Singh, Director, Government …

After 100 crore milestone, Narendra Modi to meet seven Indian COVID-19 vaccine manufacturers today
3 years, 2 months ago

After 100 crore milestone, Narendra Modi to meet seven Indian COVID-19 vaccine manufacturers today

Firstpost  

Representatives from Serum Institute of India, Bharat Biotech, Dr Reddy’s Laboratories, Zydus Cadila, Biological E, Gennova Biopharma and Panacea Biotech will attend the meet New Delhi: Prime Minister Narendra Modi will meet seven Indian COVID-19 vaccine manufacturers on Saturday, a meeting that comes in the wake of the country achieving the landmark of administering 100 crore doses of the jabs, …

Mix-and-match vaccines highly effective against COVID-19: Lancet study
3 years, 2 months ago

Mix-and-match vaccines highly effective against COVID-19: Lancet study

Deccan Chronicle  

London: People who received a first dose of the Oxford-AstraZeneca COVID-19 vaccine followed by an mRNA vaccine shot had a lower risk of infection compared to those immunised with both doses of the AstraZeneca preventive, according to a nationwide study in Sweden. "However, our study shows a greater risk reduction for people who received an mRNA vaccine after having received …

WHO 'Deeply Concerned' Over Covid Vaccines Approved for Emergency Use Not Being Recognised in All Countries: Official
3 years, 2 months ago

WHO 'Deeply Concerned' Over Covid Vaccines Approved for Emergency Use Not Being Recognised in All Countries: Official

News 18  

The World Health Organisation is deeply concerned that COVID-19 vaccines that have proven to be effective and have been approved by the global health body for emergency use are not being recognised in all countries, an official said on Thursday. Addressing a press briefing, Dr Bruce Aylward, Senior Advisor to WHO Director General Dr Tedros Adhanom Ghebreyesus, said the organisation …

WHO 'deeply concerned' over Covid vaccines approved for emergency use not being recognised in all countries
3 years, 2 months ago

WHO 'deeply concerned' over Covid vaccines approved for emergency use not being recognised in all countries

India TV News  

The World Health Organisation is “deeply concerned” that COVID-19 vaccines that have proven to be effective and have been approved by the global health body for emergency use are not being recognized in all countries, an official said on Thursday. Addressing a press briefing, Dr. Bruce Aylward, Senior Advisor to WHO Director-General Dr. Tedros Adhanom Ghebreyesus, said the organization again …

India Allows Serum Institute to Enrol 7-11-year-olds in Novavax Covid-19 Vaccine Trial
3 years, 2 months ago

India Allows Serum Institute to Enrol 7-11-year-olds in Novavax Covid-19 Vaccine Trial

News 18  

India's drug regulator on Tuesday allowed vaccine maker Serum Institute to enrol kids aged 7-11 years for its trial of US drugmaker Novavax's Covid-19 vaccine, as the country prepares to protect children from the novel coronavirus. "After detailed deliberation, the committee recommended for allowing enrolment of subjects of 7 to 11 years of age group as per the protocol," a …

Sputnik Light, J&J take another step towards joining India's COVID vaccine arsenal
3 years, 3 months ago

Sputnik Light, J&J take another step towards joining India's COVID vaccine arsenal

Firstpost  

While Sputnik Light has received DCGI’s approval for phase-3 bridging trials, around 35 lakh doses of J&J’s vaccine have been dispatched for final round of quality and safety checks in HP In an affidavit dated 26 June, the Centre had told the Supreme Court that a total of 135 crore doses of COVID-19 vaccines will be made available to the …

Dr Reddy’s Labs gets approval for phase 3 trials of Sputnik Light in India
3 years, 3 months ago

Dr Reddy’s Labs gets approval for phase 3 trials of Sputnik Light in India

Hindustan Times  

India’s drugs regulator has granted permission to Dr Reddy’s Laboratories to conduct phase 3 clinical trials for Sputnik Light, the single dose and first component of the Russian made Sputnik V vaccine against Coronavirus disease. The subject expert committee of the Central Drugs Standard Control Organisation, in its 172nd meeting last month, recommended the drugs controller to grant approval to …

India to Begin Testing Russia’s Single-Shot Sputnik Light Shortly, 1st Tranche Sent for Quality Testing
3 years, 3 months ago

India to Begin Testing Russia’s Single-Shot Sputnik Light Shortly, 1st Tranche Sent for Quality Testing

News 18  

As India gears up to kick-start the bridging trial of Russia’s single-shot vaccine, Sputnik Light, the first tranche has been sent for quality and safety validation, News18.com has learnt. “While samples of Sputnik Light, manufactured by domestic pharma company Panacea Biotec, have already been sent for quality, safety checks at the Central Drugs Laboratory in Kasauli, the hospitals have also …

Biological E.’s COVID-19 vaccine approved for advanced trials on children
3 years, 3 months ago

Biological E.’s COVID-19 vaccine approved for advanced trials on children

The Hindu  

Hyderabad-based pharmaceutical company Biological E. Limited has been approved by the Drugs Controller General of India to conduct further trials of its vaccine Corbevax on children and adolescents. Health Ministry officials said in June that the Centre had reserved 30 crore doses of the vaccine for inclusion into India’s vaccination drive. These approvals encourage our organisation to move forward and …

Biological E's ‘Corbevax’ gets DCGI approval for two clinical trials
3 years, 3 months ago

Biological E's ‘Corbevax’ gets DCGI approval for two clinical trials

Hindustan Times  

The Drugs Controller General of India has given approval to Biological E for two clinical trials of its Covid-19 vaccine candidate Corbevax, the ministry of science and technology announced Friday. The Hyderabad-based pharmaceutical company received approval for Phase 3 comparator safety and immunogenicity trial in adults after a review of Phase 1 and 2 clinical trials data by a subject …

DGCI Gives Nod for Phase 2/3 Trials of Biological E's Covid Vaccine for Children
3 years, 3 months ago

DGCI Gives Nod for Phase 2/3 Trials of Biological E's Covid Vaccine for Children

News 18  

The Drugs Controller General of India on Wednesday granted permission to Hyderabad-based Biological E Limited to conduct phase 2/3 clinical trials of its ‘Made in India’ COVID-19 vaccine on children aged between 5 and 18 years with certain conditions, sources said. Meanwhile, the data of phase 2/3 clinical trials of Bharat Biotech’s Covaxin in the age group 2 to 18 …

COVID-19: India's First mRNA Vaccine Safe, Gets Nod for Phase 2 and 3 Trials
3 years, 4 months ago

COVID-19: India's First mRNA Vaccine Safe, Gets Nod for Phase 2 and 3 Trials

The Quint  

The Central Drugs Standard Control Organisation, India's National Regulatory Authority, has approved Gennova Biopharmaceuticals Limited's work on the country's first mRNA-based COVID-19 vaccine for its clinical data of the phase-1 study. "Vaccine Subject Expert Committee reviewed the interim phase-1 data and found that HGCO19 was safe, tolerable, and immunogenic in the participants of the study. The Director General, CDSCO, approved …

Gennova’s mRNA-based COVID-19 vaccine gets approval for Phase 2/3 clinical trials
3 years, 4 months ago

Gennova’s mRNA-based COVID-19 vaccine gets approval for Phase 2/3 clinical trials

The Hindu  

India’s first mRNA-based COVID-19 vaccine candidate HGCO19 by Gennova Biopharmaceuticals Ltd has been granted approval for Phase 2/3 clinical trails, the Department of Biotechnology said on Tuesday. The Pune-based biotechnology company had submitted the interim clinical data of the vaccine’s Phase 1 study to the Central Drugs Standard Control Organisation, it said. Gennova’s mRNA-based COVID-19 vaccine development programme was partly …

India's First mRNA-Based Covid Vaccine Gets DCGI Approval For Phase 2-3 Trials
3 years, 4 months ago

India's First mRNA-Based Covid Vaccine Gets DCGI Approval For Phase 2-3 Trials

ABP News  

New Delhi: India's first mRNA-based Covid-19 vaccine on Tuesday got the Drugs Controller General of India nod to move into Phase 2 and 3 trials. According to reports, the Centre informed that the vaccine developed by Gennova Biopharmaceuticals Ltd. was found to be safe, and was given go-ahead for Phase II/III trials. "After establishing the safety of our mRNA-based COVID-19 …

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