Covaxin launch now depends on clinical sites' deadline

There are 12 sites across India, including private and public hospitals, conducting Phase 1 and 2 human clinical trials for Bharat Biotech’s Covaxin. Based on an earlier letter by the Indian Council of Medical Research (ICMR) to the 12 sites, volunteer recruitments for the clinical trials were to begin by July 7. At least three sites are yet to kick-start the process. 

After the country’s apex health research institute tried to allay concerns over setting a hurried deadline to find India’s indigenous Covid-19 vaccine, it is now up to clinical sites to ensure trials happen swiftly, albeit following due process.

Sites Business Standard spoke to say they might take their own time. This will largely depend on getting the logistics right before volunteer recruitments are set in motion. 

There are 12 sites across India, including private and public hospitals, conducting Phase 1 and 2 human clinical trials for Bharat Biotech’s Covaxin. 

Based on an earlier letter by the Indian Council of Medical Research (ICMR) to the 12 sites, volunteer recruitments for the clinical trials were to begin by July 7. At least three sites are yet to kick-start the process. 

At Jeevan Rekha Hospital in Belgaum -- one of the 12 clinical trial sites -- investigators are awaiting further communication from the ICMR and Bharat Biotech, with volunteer screening and recruitment yet to begin any time soon. 

The Institute of Medical Sciences and SUM Hospital in Bhubaneswar is awaiting a site initiation visit (SIV) by Bharat Biotech. 

Another site in South India said it had not started screening patients. Its site initiation process is awaited. 

“We will start recruiting in two-three days. We will follow a 28-day timeline for Phase 1. Once Phase 1 trials are completed and the data duly analysed, we will start Phase 2. The process may take 180 days,” said a site lead. 

Meanwhile, the Jaipur site said it was awaiting the vaccine samples. 

“The SIV is conducted to check whether all safety protocols for the clinical trials are being met. This is yet to happen and should be completed in a day or two. It is only after the SIV will the site begin screening volunteers for clinical trials or even receive vaccine samples from the sponsor. The timeline for clinical trials is now site-specific,” said Venkata Rao at the Institute of Medical Sciences and SUM Hospital. 

Before the ICMR retracted the August 15 deadline, clinical trial sites were divided in their opinion on the timeline as well as the protocols to be followed. Some even said Phase 1 and 2 would be conducted together and the trials would end in a month’s time, while others felt it was impossible to adhere to the deadline. 

Chandrasekhar Gillurkar of the Gillurkar Multispeciality Hospital & Research Centre in Nagpur -- one of the 12 sites -- had told Business Standard that after the vaccine was given (counted as Day Zero), the site would wait for a fortnight. The second dose will be given before the 14th day. After the second dose, these volunteers will again be checked a fortnight later to see if they develop antibodies. 

The Phase 1 and 2 trials will be on 1,125 volunteers, of which 375 will be in Phase 1. Sources revealed that after Phase 2 ends, the country’s drug regulator is likely to take a call on whether to launch the vaccine on compassionate-use grounds, at least for health care workers.

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