‘Covaxin Phase-III trials nearing 20k volunteers’

Does not commit on timelines of release of the vaccine candidate

The ongoing Phase III-trial for Covaxin, the indigenous vaccine candidate for COVID-19 Hyderabad-based vaccine maker Bharat Biotech is developing in collaboration with ICMR-National Institute of Virology, is nearing 20,000 volunteers.

“We are doing (the Phase III trial) in 26,000 people. As we speak, we are crossing 20,000 people already in the trial,” Bharat Biotech chairman and managing director Krishna Ella said while delivering the 9th Dr. Manohar V.N. Shirodkar Memorial Lecture virtually.

His statement follows an announcement a week ago by the company that it has successfully recruited 13,000 volunteers across the country. It also assumes significance in the backdrop of some reports on how finding the requisite number of volunteers posed challenge at certain trial sites. The company had sought to highlight how with 26,000 volunteers it would be the largest Phase III efficacy trial ever conducted for any vaccine in the country.

“This is probably the first efficacy trial in the developing world. We are really the safest vaccine and have had five publications in last six months,” Mr. Ella said. While not mentioning any timeline related to the trial, he said the vaccine availability was dependent on regulatory approval.

An expert committee of the Drugs Controller General of India had recently put on hold an Emergency Use Authorisation filed by Bharat Biotech.

The company has set up the first BSL-3 production facility for the vaccine, he said, adding the Covaxin has the lowest adverse effects at about 15%.

Delivering the lecture, which is a part of the Endowment Lecture Series instituted by Rajkumari Indira Devi Dhanarajgiri and hosted by the Telangana Academy of Sciences, Mr. Ella traced the various vaccine developed by Bharat Biotech. He said the company, in association with Washington University of Medicine in St.Louis, was also developing a novel chimp adenovirus, single-dose intranasal vaccine for COVID-19.

“We decided to go in for a nasal vaccine as it is much better in delivering the medication and also reduces pollution on earth” since other vaccines require syringes and needles whose disposal will be a challenge, he said. Moreover, nasal vaccine is effective to both upper and lower respiratory tracts, he said, pointing out that a two dose vaccine for a country like India — with a population of 1.3 billion — would need 2.6 billion syringes.

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