COVAXIN, ZyCoV-D complete phase 1 trial; SII to begin testing for Oxford COVID-19 vaccine next week


COVAXIN, ZyCoV-D complete phase 1 trial; SII to begin testing for Oxford COVID-19 vaccine next week&nbsp | &nbspPhoto Credit:&nbspiStock Images

New Delhi: Two indigenously developed vaccines for the novel coronavirus have completed phase 1 trial and begun phase 2 studies, the Indian Council of Medical Research (ICMR) said on Tuesday. COVAXIN, India’s first indigenous coronavirus vaccine developed by Bharat Biotech in collaboration with ICMR, and Zydus Cadila’s  ZyCoV-D, a DNA vaccine against the SARS-CoV-2, have shown satisfactory results in preclinical studies.

Meanwhile, Serum Institute of India (SII) may begin the phase 2 and 3 clinical trials of the Oxford-AstraZeneca COVID-19 vaccine next week following approval by the Indian drug controller on Monday.

India's 3 COVID-19 vaccines in different phases of clinical testing

The ICMR on Tuesday said that three Indian COVID-19 vaccines are in different phases of clinical testing, reported ANI. Dr Balram Bhargava, DG, ICMR while addressing a press conference, said that two indigenous vaccines - COVAXIN and DNA vaccine of Zydus Cadila - have completed phase 1 and started the phase 2 studies. Trial for the third candidate, which is the Oxford vaccine, will begin the trial within a week.

“Oxford vaccine, being manufactured by Serum Institute of India (SII) got approval for phase 2 and 3 clinical trials, which are starting within a week at 17 sites,” he added.

Oxford COVID-19 vaccine to begin phase 2/3 trials in India

The ChAdOx1 nCoV-19 (AZD1222) vaccine developed by the University of Oxford has shown an acceptable safety profile and strong immune response in early trials. The vaccine - called Covishield in India - will start trials within a week. Trial data published in the journal The Lancet showed that the vaccine provoked a T-cell response within 14 days of vaccination, and an antibody response within 28 days. T-cells are white blood cells that can attack coronavirus infected cells, whereas antibodies are protein molecules that able to neutralise the virus so that it cannot infect cells when initially contracted.

The researchers reported that the vaccine candidate was safe and tolerated, with reduced reactogenicity when paracetamol was used prophylactically for the first 24 hours after vaccination.

“We saw the strongest immune response in the 10 participants who received two doses of the vaccine, indicating that this might be a good strategy for vaccination,” Professor Pollard was quoted as saying.

In India, SII will recruit 1,600 healthy individuals above 18 years of age for the trials which will be carried out across 17 sites in India, including PGIMER Chandigarh, AIIMS in Delhi, ABJ Medical College in Pune, Rajendra Memorial Research Institute of Medical Sciences (RMRIMS) in Patna, AIIMS in Jodhpur, Nehru Hospital in Gorakhpur, Andhra Medical College in Visakhapatnam and JSS Academy of Higher Education and Research in Mysuru.

CEO Adar Poonawalla had said that the company aims to manufacture 300-400 million doses of the vaccine by the year-end, if trials succeed, adding that Covishield will cost less than Rs 1,000 per dose.

As per the World Health Organization (WHO), six experimental COVID-19 vaccines have moved into the final phase of testing as scientists race against time to find a safe and effective vaccine against coronavirus, which has so far claimed at least 694,507 lives and infected 18,324,580 people in the world.



Source link