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According to sources, the launch of Covaxin will depend on its overall trial. Researchers will check the effectiveness of the vaccine for at least 6 months.
Recently, India's drug regulator had given a green signal for the start of human clinical trials for the COVID-19 vaccine candidate Covaxin, developed by the Hyderabad-based Bharat Biotech in collaboration with the ICMR and the National Institute of Virology (NIV). Soon after this, on Saturday, AIIMS Ethics Committee gave its approval for conducting the human clinical trial of the indigenously developed COVID-19 vaccine candidate Covaxin. Trials started on Monday.
According to AIIMS director, Dr Guleria, Phase 1 vaccine trial will be conducted on healthy people aged 18-55 years who have no co-morbidity. The call for volunteers was received well by people and many came forward after approval for trials was granted. Though AIIMS needs only 100 participants for the trial, 1,800 people came forward to volunteer for the same.
Total number of participants for human trials across India is 375. Of these 100 participants will participate at the AIIMS trial. All of them are between the ages of 18 to 55 years. Pregnant women and those with comorbidities are exempt. All participants will be screened for diabetes, hypertension and kidney function. Only those who clear the screening are allowed to participate. Immunity of participants is also checked before they are administered the vaccine. A total of 1,125 samples have been collected, which will be used for trials in the first two phases.
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After the screening, select candidates will be given the vaccine. They will be tested after one, four and six weeks to check for allergic reactions and antibody development. All participants will also be followed for 6 months to see the long-term effects of the vaccine. Human trials of Covaxin will be conducted in three phases. Phase 1 will be conducted on healthy people between the ages of 18-55 years. So far, AIIMs has collected a total of 1,125 samples. Out of this, 375 people will be studied in the first phase of trials and 750 people between the ages of 12-65 years will be studied in the second phase. The first and second phase in AIIMS (Delhi) will choose only 100 participants out of 375 volunteers and the remaining will participate at other sites where trials are being held. In phase 3, they premier institute will test the efficacy and effectiveness of the vaccine.
According to sources, the launch of Covaxin will depend on its overall trial. Researchers will check the effectiveness of the vaccine for at least 6 months. So ideally, by the end of this year or early next year, there are chances that there will be a vaccine for COVID-19.
Zydus Cadila started clinical trials of its COVID-19 vaccine candidate with the first human dosing last week. Another major player in the vaccine scene, Serum Institute of India, which is working on the AstraZeneca Oxford vaccine, plans to start human trials in India in August 2020.
(With input from Agencies)