The CEPI will fund the researchers to conduct activities including immunogen design, preclinical studies, manufacturing process development, and a Phase 1 clinical trial.
The WHO said in a statement late on on Saturday that the Covaxin suspension was in response to the outcomes of its post EUL (emergency use authorisation) inspection, held between March 14-22, and the need to conduct process and facility upgrades to address recently identified GMP (good manufacturing practice) deficiencies.
Bharat Biotech on April 1 announced the temporary slowing down of production of its covid-19 vaccine Covaxin across its manufacturing facilities, having completed its supply obligations to procurement agencies and foreseeing the decrease in demand.
Hyderabad-based vaccine manufacturer Bharat Biotech on Friday announced the temporary slowing down of its Covid vaccine Covaxin's production across its manufacturing facilities.
Bharat Biotech has received approval from the Drug Controller General of India to conduct phase-3 trials for its COVID-19 intra-nasal vaccine (BBV154), sources in the company said on Friday.
Dr Krishna Ella and Suchitra Ella, the couple behind Bharat Biotech, which developed India's first indigenous vaccine for Covid-19, have been awarded Padma Bhushan, the third highest civilian award in the country.
COVAXIN Booster Dose Data Shows Promising Results
"Through our clinical trials spanning 30,000 individuals, approximately 10-20 per cent individuals report side effects. Most of these are mild, resolve within 1-2 days, and do not require medication. Medication is only recommended only after you consult a physician," the company said.
According to a source, Bharat Biotech aims to conduct clinical trials on 5,000 healthy subjects: half or 2,500 individuals who have received Covishield and another 2,500 who have been administered Covaxin.
No serious adverse event was reported. 374 subjects reported either mild or moderate severity symptoms with 78.6 per cent getting resolved within one day.
"It is a big concern if it plays in view of the driver, for sure," Jonathan Adkins, executive director of the Governors Highway Safety Association, which coordinates state efforts to promote safe driving, was quoted as saying.
The phase 3 trial Efficacy and Safety Study involving 25,800 volunteers across 25 sites in India is India's largest ever clinical trial conducted for a Covid-19 vaccine.
Covaxin uses the same Vero Cell manufacturing platform as other childhood vaccines, including the inactivated polio vaccine.
Covaxin Gets WHO Nod; Union Health Minister’s Reaction
This recognition is for travellers aged 12 and over who have been vaccinated with Covaxin, and those 18 to 60 who have been vaccinated with BBIBP-CorV.
The Drugs and Comptroller General of India (DCGI) has given a go-ahead to Bharat Biotech's Covaxin for vaccination of children in the 2-18 years age group.
India's vaccination coverage against coronavirus under the mass vaccination drive has crossed the landmark of 63 crore. Over 73 lakh doses have been administered in the last 24 hours.
The results of Phase II and III trials of COVAXIN are going on for children in the age group of 2-18 years. So, by September or just after it, we may have COVID-19 vaccines for children, said Priya Abraham, Director of ICMR-NIV
The regulatory approval has been received for conducting "Phase 2 randomised, multi-centric, clinical trial of heterologous prime-boost combination of SARS-CoV-2 vaccines to evaluate the immunogenicity and safety of BBV152 (Covaxin) with BBV154 (Adenoviral Intranasal Covid-19 vaccine) in healthy volunteers.
India's Covid vaccination coverage has crossed 51 crores cumulatively.
The Hyderabad-based company had said in May that that application for EUL was submitted to WHO-Geneva and regulatory approvals are expected by July-September 2021.
Novavax Inc had announced that NVX-CoV2373, its recombinant nanoparticle protein-based Covid-19 vaccine, demonstrated 100 per cent protection against moderate and severe disease, 90.4 per cent efficacy overall.
Bharat Biotech dispatched its Covid-19 vaccine Covaxin to nine states through the government of India and to 16 states through the respective state governments.
The FDA had on Thursday recommended Ocugen, the US partner of the Indian vaccine maker, to "pursue a Biologics Licence Application (BLA) submission instead of an EUA application" and "requested additional information and data".
Bharat Biotech has been directly supplying its Covid-19 vaccine Covaxin to 18 states since May 1
Bharat Biotech has started direct supplies of its Covid-19 vaccine Covaxin to 14 states.
Bhubaneswar: A day after Serum Institute of India reduced Covishield vaccine price for States to Rs 300 per dose as a philanthropic gesture, Bharat Biotech also slashed the price of…
New Delhi: Bharat Biotech on Saturday said it would provide its COVID-19 vaccine, Covaxin, to state governments at Rs 600 per dosage. The Hyderabad-based vaccine major also said that it would…
New Delhi: Increasing efforts towards faster mass vaccination and virus surveillance is the key to ward off dangers posed by a triple-mutant coronavirus now present in the country, health experts…
New Delhi: Looking to ramp up supplies ahead of the opening of Covid-19 vaccination to all citizens over 18 years of age, the government has approved a payment of about…
New Delhi: Bharat Biotech’s Covaxin has a negligible number of side effects reported among the beneficiaries of the Covid-19 vaccine, NITI Aayog’s Member (Health), VK Paul said on Thursday. “The vaccine has been administered so far to 19 lakh people and only 311 individuals of them have reported minimal side effects. “It has stood the […]
Hyderabad: Bharat Biotech on Wednesday announced the first interim analysis of Covaxin, which shows the efficacy of the Covid-19 vaccine to be at 81 per cent. The Hyderabad-based vaccine maker said whole virion inactivated Covid-19 vaccine candidate demonstrated an interim vaccine efficacy of 81 per cent in its Phase 3 clinical trial. The trials involved […]
Bhubaneswar: With the ‘vaccine hesitancy’ getting manifested in nearly half a dozen districts– including the Capital City– in the State despite a mere 0.01 per cent showing any AEFI (adverse events following immunisation) signs, the two vaccine manufacturers – Bharat Biotech and Serum Institute India – have released fact-sheets that tell who are eligible for […]
New Delhi: Days before the commencement of the nationwide Covid-19 vaccination drive, the Union Health Ministry said on Tuesday that 1.1 crore Covishield and 55 lakh Covaxin vaccines have been procured at a cost of Rs 200 and Rs 206 per dose, respectively. However, BBIL will provide 16.5 lakh doses of Covaxin free of cost […]
New Delhi: Vaccine makers Serum Institute of India and Bharat Biotech on Tuesday said both the companies jointly pledge for smooth roll out of COVID-19 vaccines in the country and the world. In a show of solidarity after some bitter comments, Adar Poonawala and Krishna Ella, jointly on behalf of Serum Institute and Bharat Biotech, […]
New Delhi: Hyderabad-based Bharat Biotech has sent the first batch of its Covid vaccine, Covaxin, to the government for further distribution as the immunisation drive in the country is set to start in coming days, its CMD Dr Krishna Ella said on Monday. “We have already sent the batch to the Central Research Institute in […]
New Delhi: The All India Drug Action Network (AIDAN) said it is shocked to learn of the SEC’s recommendation to grant REU approval to Bharat Biotech’s COVAXIN in “clinical trial mode” and “specially in the context of infection by mutant strains”. “In light of the intense concerns arising from the absence of efficacy data and […]
New Delhi: The Subject Expert Committee of Central Drug Standard Control Organization on Saturday recommended Bharat Biotech’s ‘Covaxin’ for emergency use in India. However, the final decision on its approval will be taken by the Drug Controller General of India (DCGI). Expert panel recommends granting permission for restricted emergency use authorization for Bharat Biotech’s indigenously […]
New Delhi: Bharat Biotech has said that it will be advisable to participate in the Phase 3 efficacy trial for its indigenous Covaxin and get vaccinated to ensure protection against Covid-19 as it may take months for people above 50 years to get the vaccine. In frequently asked questions (FAQ) on its vaccine trials, Bharat […]
Hyderabad: Bharat Biotech on Tuesday announced successful recruitment of 13,000 volunteers, and continued progress towards achieving the goal of 26,000 participants for Phase III clinical trial of its coronavirus vaccine Covaxin across multiple sites in India. The Phase III human clinical trials of Covaxin began mid-November, targeted to be done in 26,000 volunteers across India. […]