JSS Academy of Higher Education and Research (JSSAHER), which has already begun phase three of the clinical trials for vaccine candidate Covishield at its facility in Mysuru, has been approached for human trials of Novavax, another COVID-19 vaccine candidate developed by a U.S.-based company, as well as Russia’s Sputnik V.
JSSAHER Pro-Chancellor B. Suresh said the institution has consented to carrying out trials for Novavax, while the request on Sputnik V has been kept in abeyance.
Novavax, the U.S.-based biotechnology company, had entered into a manufacturing pact with the Pune-based Serum Institute of India (SII). “Novavax approached us through SII and we consented to it. We will be submitting the required documents shortly,” he said.
Though the institution was also approached for the human trials of Sputnik V, which has tied up with the Hyderabad-based Dr. Reddy’s Laboratories, Dr. Suresh said JSSAHER was still studying the proposal.
Apart from carrying out clinical studies for Covishield, the vaccine candidate developed by Oxford University and multi-national pharmaceutical company AstraZeneca, JSSAHER has taken up human trials to study the efficacy of BCG, the anti-tuberculosis vaccine, against COVID-19.
As part of the studies on BCG vaccine, about 250 elderly citizens in the age group of 60 to 80 will be inoculated with a dose of the anti-tuberculosis vaccine and monitored for the presence of antibodies in their blood and their response in the context of COVID-19.
The flood of enquiries received by JSSAHER for carrying out human trials of COVID-19 vaccines comes in the backdrop of the legal requirements for manufacturing vaccines in the country. Dr. Suresh pointed out that a lot of interest has been generated for human trials in India because of the country’s huge capacity for manufacturing drugs. “Also, by law, you cannot manufacture the drug elsewhere and import it into India. If you are manufacturing in India a vaccine developed elsewhere, you should carry out the trials in India,” he said.
Manufacture of vaccines can be allowed in India only after trials are conducted in the country and evidence of the trials on Indian population submitted. “Only then can you make it available to the people of the country,” Dr. Suresh said.
Dr. Suresh also said phase three of the Covishield trials had begun after no adverse effect was shown on any of the 25 healthy volunteers who enrolled for the trials. Phase three is expected to test the immunogenicity of the vaccine, crucial to check if the shots had helped produce antibodies in the blood to fight COVID-19.