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Home >News >India >Coronavirus vaccine: Dr Reddy's partners with BIRAC for trials of Sputnik V in India
Earlier this month, Dr Reddy's and RDIF received approval from DCGI to conduct an adaptive phase 2/3 human clinical trial for Sputnik V vaccine in India. (MINT_PRINT)
Earlier this month, Dr Reddy's and RDIF received approval from DCGI to conduct an adaptive phase 2/3 human clinical trial for Sputnik V vaccine in India. (MINT_PRINT)

Coronavirus vaccine: Dr Reddy's partners with BIRAC for trials of Sputnik V in India

  • Currently, 2 indigenously developed vaccine candidates for Covid, one by Bharat Biotech in collaboration with ICMR and another one by Zydus Cadila, are undergoing phase 2 of human clinical trials
  • Serum Institute, which has partnered with AstraZeneca for manufacturing the Oxford vaccine is also conducting phase 2 and phase 3 human clinical trials in India

Announcing its partnership with the Biotechnology Industry Research Assistance Council (BIRAC), set up by the Department of Biotechnology, for advisory support on clinical trials of Russian coronavirus vaccine, Sputnik V, in India, Dr Reddy's Laboratories said, "The partnership will allow Dr Reddy's to identify and use some of BIRAC's clinical trial centres for the vaccine, which are funded under the National Biopharma Mission (NBM), implemented by Project Management Unit-NBM at BIRAC."

The drug major on Thursday said in a regulatory filing: “Further, the company will have access to good clinical laboratory practice (GCLP) labs to conduct immunogenicity assay testing of the vaccine."

As of now, two indigenously developed vaccine candidates for coronavirus, one by Bharat Biotech in collaboration with ICMR and another one by Zydus Cadila, are undergoing phase 2 of human clinical trials.

Pune-based Serum Institute of India (SII), which has partnered with AstraZeneca for manufacturing the Oxford Covid-19 vaccine is also conducting phase 2 and phase 3 human clinical trials in the country.

Satish Reddy, Chairman, Dr. Reddy’s Laboratories said, “We are pleased with the collaboration with BIRAC as an advisory partner for clinical trials of the Sputnik V vaccine in India. We look forward to working with them to accelerate our efforts in bringing the vaccine to India."

Commenting on the collaboration with Dr. Reddy’s, Dr Renu Swarup, Secretary, DBT and Chairperson, BIRAC said, "The government is committed to fast track clinical development of COVID vaccine candidates and provide facilitation to accelerate market readiness of a suitable vaccine. We at DBT look forward to this partnership with Dr. Reddy’s for this Indo Russian Collaboration for Vaccine Development."

India trial results of Sputnik V

Meanwhile, Dr Reddy's Laboratories, which is conducting the India trials of the Russian coronavirus vaccine Sputnik V, has said the late-stage trials are expected to be completed by March next year.

According to a report, Dr Reddy’s CEO Erez Israeli has said enrolment to the mid-stage trial of the Sputnik V vaccine will start in the next few weeks and the trial was likely to end by December.

Oxford India trial vaccine results

Oxford and AstraZeneca’s vaccine that is also undergoing clinical trials in India are expected to be over by January, said SII CEO Adar Poonawalla.

“We have already given the first dose to most of the patients in the trial, which is more than a 1,000 already. The total trial is for 1,600 patients in India. Then we will give the second dose and then and then analyse them for safety and efficacy," said Adar Poonawalla, as per reports.

The AstraZeneca Covid-19 vaccine is at Phase III trials in the country and other parts of the world. It is one of the most-anticipated coronavirus vaccine candidate across the world.

Coronavirus vaccine status worldwide

Senior officials in the British government believe that a German coronavirus vaccine backed by Pfizer could be ready to distribute by Christmas before the results are in on AstraZeneca’s competing vaccine, with the first doses earmarked for the elderly and vulnerable, according to a report.

“Senior government sources expect that a verdict on whether it works will be available before Oxford’s competing vaccine, which may not provide results until after Christmas," the report said.

Chief executive of Pfizer, Albert Bourla said that the Covid-19 vaccine was in the “last mile" and that the pharmaceutical firm expected results within a matter of weeks.

Earlier on October, Dr Reddy's and Russia Direct Investment Fund (RDIF) received approval from the Drugs Controller General of India (DCGI) to conduct an adaptive phase 2/3 human clinical trial for Sputnik V vaccine in India.

On August 11, 2020, the Sputnik V vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia and became the world's first registered vaccine against COVID-19 based on the human adenoviral vector platform.

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