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Many human trials of hopeful COVID-19 vaccines are going on in many parts of the world. India, too, has initiated clinical trials of Covishield. The first dose of this COVID-19 vaccine candidate developed by the Oxford University and AstraZeneca will be administered to three volunteers at the King Edward Memorial (KEM) Hospital in Mumbai today while 10 more volunteers have been selected for the human clinical trial. Another Mumbai hospital BYL Nair will commence the process of clinical trials from Monday.
Meanwhile, the Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, has already administered the first dose of this vaccine to three candidates on Friday. This marked the start of clinical trials of this vaccine in India. Two women and a man were given dosage of 0.5 ml. The PGIMER in Chandigarh is one of the 17 sites where the phase II trials of the 'Covishield' vaccine developed by Oxford University and being mass-produced by Pune based Serum Institute of India (SII) is being conducted. Eighteen candidates have been found eligible here till now to undergo the trial. The institute plans to take 100 candidates into the phase II study while it has made commitment for 253 candidates to Indian Council of Medical Research (ICMR).
The trials were suspended pan-India by Central Drugs Standard Control Organisation (CDSCO) after COVID-19 vaccine trials were put on hold in the United Kingdom (UK) as one of the participants there reported a severe adverse reaction following administration of a booster dose. The suspension was revoked by Drugs Controller General of India (DCGI) last week only. The vaccine induces a strong immune response. It provokes a T cell (white blood cells that can attack cells infected with the coronavirus) response within 14 days of the dose, and an antibody response within 28 days.
According to Indian Council of Medical Research (ICMR) guidelines, each of the volunteers has been covered with Rs 1crore life insurance in case of death due to any side effects during the trial. They have also been covered under Rs 50lakh medical insurance if they develop any adverse effect from the vaccine.
A source privy to the development confirmed that the candidates will be monitored for 28 days after the 0.5 ml dose of vaccine and then the second dose will be given followed by a monitoring of 28 days. After that a blood sample will be taken and they will be observed for a span of six months. Besides, the candidates have also been asked to note any development of symptoms like fever in their personal diary.
The criteria fulfilling the eligibility prerequisites for the study included the minimum age of 18, no underlying medical condition and no prior COVID-19 infection. Besides, family members of the candidates are also required to be COVID negative. Volunteers underwent RT-PCR and antibody testing. They were screened for comorbidity.
(With inputs from IANS)