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JSS Academy of Higher Education and Research (JSSAHER), which has already begun section three of the clinical trials for vaccine candidate Covishield at its facility in Mysuru, has been approached for human trials of Novavax, one other COVID-19 vaccine candidate developed by a U.S.-based firm, in addition to Russia’s Sputnik V.
JSSAHER Pro-Chancellor B. Suresh mentioned the establishment has consented to carrying out trials for Novavax, whereas the request on Sputnik V has been saved in abeyance.
Novavax, the U.S.-based biotechnology firm, had entered into a producing 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 mentioned.
Though the establishment was additionally approached for the human trials of Sputnik V, which has tied up with the Hyderabad-based Dr. Reddy’s Laboratories, Dr. Suresh mentioned JSSAHER was nonetheless finding out the proposal.
Apart from carrying out clinical research for Covishield, the vaccine candidate developed by Oxford University and multi-national pharmaceutical firm AstraZeneca, JSSAHER has taken up human trials to examine the efficacy of BCG, the anti-tuberculosis vaccine, in opposition to COVID-19.
As a part of the research on BCG vaccine, about 250 aged residents in the age group of 60 to 80 will likely 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 acquired by JSSAHER for carrying out human trials of COVID-19 vaccines comes in the backdrop of the authorized necessities for manufacturing vaccines in the nation. Dr. Suresh pointed out that a number of curiosity has been generated for human trials in India due to the nation’s enormous capability for manufacturing medicine. “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 mentioned.
Manufacture of vaccines will be allowed in India solely after trials are performed in the nation and proof of the trials on Indian inhabitants submitted. “Only then can you make it available to the people of the country,” Dr. Suresh mentioned.
Dr. Suresh additionally mentioned section three of the Covishield trials had begun after no antagonistic impact was proven on any of the 25 wholesome volunteers who enrolled for the trials. Phase three is anticipated to check the immunogenicity of the vaccine, essential to verify if the photographs had helped produce antibodies in the blood to combat COVID-19.
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