Tag: covaxin

Shares of Hester Biosciences gained 19 per cent to Rs 2,944 on the BSE in intra-day trade on Monday, up 33 per cent in the past two trading days, after the pharmaceutical company said it has tied up with the Gujarat government to explore the production of Covid-19 vaccine through technology transfer from Bharat Biotech. Rajiv Gandhi, Hester Biosciences CEO and MD, said in a statement, "A triparty consortium has been formed with the Government of Gujarat as the lead partner, to explore the prospects of manufacturing the Covid vaccine through technology from Bharat Biotech. "The discussions are currently ongoing with Bharat Biotech towards reviewing the infrastructure at Hester, the technology adaption process and the regulatory compliances, he added. Read more

Covaxin, developed by Hyderabad-based Bharat Biotech International (BBIL), appeared to inch closer to approval as its phase 1 clinical trial results showed a ‘’robust’’ immune response without any serious adverse events, the firm said in a research paper. Bharat Biotech had recently sought an accelerated approval from the regulator based on phase 1 and phase 2 studies. The company is in the middle of conducting a phase 3 trial with 22,000 subjects. Serum Institute of India, which is partnering with Astra Zeneca and Oxford University for the Covid vaccine, has also sought emergency approval. Pfizer-BioNTech too has applied for the same. Only one serious adverse event was reported around August which was not found to be causally linked to the investigational product, according the research paper.

An Indian government-backed COVID-19 vaccine could be launched as early as February as last-stage trials begin this month and studies have so far shown it is safe and effective, according to sources. Bharat Biotech, a private company that is developing COVAXIN with the government-run Indian Council of Medical Research (ICMR), had earlier hoped to launch it only in the second quarter of next year. "The vaccine has shown good efficacy," senior ICMR scientist Rajni Kant, who is also a member of its COVID-19 task-force, said at the research body's New Delhi headquarters on 5th November 2020.. "It is expected that by the beginning of next year, February or March, something would be available." A launch in February would make COVAXIN the first India-made vaccine to be rolled out. Read more

Hyderabad-based vaccine maker Bharat Biotech has not only started the at-risk manufacturing of its candidate Covaxin but is also looking to ramp up capacities as India’s first indigenous Covid-19 vaccine candidate gets the nod for phase 3 trials. The first vaccine candidate will be an intra-muscular one, followed by intra-dermal and nasal ones, depending on test results. Besides setting up a second plant at its Genome Valley facility in Hyderabad to make Covaxin, the firm is looking for another site in the country to make the vaccine. This would be crucial as BBIL expects to forge global partnerships with international agencies like Gavi and also some countries for Covaxin by December.

It is reported that preliminary results of phase 1 clinical trials of the Bharat Biotech-ICMR developed Covid-19 vaccine, Covaxin, suggest that the vaccine is safe. The vaccine is being tested on 375 volunteers who have enrolled at 12 sites in India. Two doses of the vaccine are being administered to each volunteer. “As of now, we know that it is safe. The second step is to know how effective the vaccine is for which we have started collecting the samples,” said Savita Verma, principal investigator, who is leading the trial at PGI, Rohtak. Read more