MUMBAI: Recruitment of participants for Bharat Biotech’s Covaxin trial ended in the two city hospitals, J J and Sion, after the company said it completed the overall target of enrolling 25,800 participants for phase III trial.
At J J Hospital in Byculla, 436 participants were recruited, against the original target of 1,000. Of these, 201 have already been administered the second dose. Civic-run Sion Hospital managed to recruit around 200 participants, confirmed dean Dr Mohan Joshi. Given the lukewarm response from common people, the hospital had to recruit several healthcare workers.
Dr Dinesh Dhodi, co-investigator in J J trial, said participants will have to undergo an RT-PCR test every month for the next seven months. After the physical follow-ups spanning eight months, there will be four telephonic follow-ups. “An interim analysis may be done in another few weeks. To understand basic efficacy, we have to wait for minimum 14 days after the second dose is completed.”
Bharat Biotech said on January 7 recruitment for all participants was complete. The company has been facing heat since Covaxin was granted emergency-use authorization by the drug regulator without the completion of phase III trials.