As India races against time to bring a safe and efficient anti-coronavirus vaccine made indigenously within the country, phase 1 of the human trials in most centres chosen for COVAXIN trials have concluded, India Today TV has learnt. The centres are now bracing for recruitment of candidates for phase 2 human trials, which are scheduled to begin in the first week of September.
Except for AIIMS Delhi - one of the 12 centres for the Bharat Biotech vaccine - where phase 1 trials are still underway, most of the other 11 centres have completed the process. AIIMS Delhi has only recruited 16 candidates for the vaccine human trials phase 1.
Initially, AIIMS Delhi was supposed to recruit 100 candidates for the vaccine trials. The total candidate recruitment for phase 1 Bharat Biotech trials in 12 centres is 375.
Sources at the AIIMS centre said that the phase 2 human trials will likely begin in the first week of September. The findings of phase 1 trials will be submitted soon. Preliminary results of Phase 1 clinical trials showed that Covaxin is safe, sources associated with the Phase1 trial have confirmed.
Meanwhile, in Maharashtra's trial centre in Nagpur phase 1 trials have been completed as 55 healthy participants were vaccinated with the first dose of vaccine, the clinical lead investigator informed India Today. "After the first dosing, two patients reported some fever-related symptoms. However, they got better after a few hours of monitoring without any medical intervention," said a source at the centre.
The second round of dosing was also done for seven candidates, two days ago. 13 more candidates were given second dosage of COVAXIN on Thursday. The centre in Nagpur submitted initial results of phase 1 human trials to Bharat Biotech, sources said.
Similarly, phase 1 trials at the Jeevan Rekha Hospital in Belgaum, Karnataka have been completed. Only four people have been vaccinated at the centre. After completion of 28 days, data of the clinical trials will be submitted to Bharat Biotech, said a source from the centre. Phase 2 trial recruitment will begin in the first week of September. These findings will be based on a monitoring done for 28 days after the Phase 1.
Three vaccine candidates are currently in different phases of human trials.
Meanwhile, the Serum Institute of India (SII) has been granted regulatory approval to conduct phase 2 and 3 trials in India Covishield, a vaccine created by the University of Oxford and AstraZeneca. SII plans to start human trials in less than two weeks, India Today has learnt.
20 different sites have been chosen along with hospitals across the country, covering five different regions that are also Covid-19 hotspots. SII will conduct trials across 11-12 hospitals in partnership with ICMR. Currently, the recruitment process for at least 1,000 candidates is underway at the trial sites.
Phase 1 trials of ZyCOV-D the vaccine being made by Zydus Cadila have been completed. The company has reported that the Phase 2 trials have commenced, and the trials will be conducted on 1,000 healthy participants in Ahmedabad.
"An independent Data Safety Monitoring Board (DSMB) endorsed the seven-day safety of the vaccine in all the Phase I participants," a statement by the company said.
Story Courtesy - www.indiatoday.in