Oxford vaccine clinical trials begin at PGI Chandigarh
New Delhi: The Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, has administered the first dose of Oxford Covid-19 vaccine -- Covishield -- to three candidates on Friday, informed PGI Chandigarh Director Prof Jagat Ram.
The clinical trials of the Oxford vaccine has started at PGI Chandigarh after the institute administered the first dosage of the vaccine to three volunteers on Friday, Prof Jagat Ram, Director, PGIMER told IANS.
Ram said that two females and a male were given a dosage of 0.5 ml. "Two females aged 57 and 26 years and a 33-year-old male were administered the vaccine candidate at the institute," he specified.
The PGIMER is one of the seventeen sites where 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.
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 been asked to note any development of symptoms like a fever in their personal diary. 18 candidates have been found eligible 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 the Indian Council of Medical Research (ICMR).
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.
The trials started after the institute received safety approval pending from the Data Safety and Monitoring Board (DSMB) for the first 100 candidates selected to undergo the trials last week. The trails have been delayed by more than two weeks. The institute had earlier claimed to start the trials by the first week of September.
However, it was initially delayed due to pending safety approvals of the candidates from DSMB. Later, 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 the administration of a booster dose. The suspension was revoked by Drugs Controller General of India (DCGI) last week only.