Clinical trial of fourth Covid-19 vaccine to start in October

The clinical trial of a fourth Covid-19 vaccine is set to start in India in October in partnership with an ICMR laboratory.

“Pune-based National AIDS Research Institute has joined hands with the Serum Institute of India for the clinical trial of a vaccine developed by a US company, Novavax. The trial will be initiated in the second half of October, once the vaccine is manufactured by the SII,” Union Minister of State for Health Ashwini Kumar Choubey informed the Rajya Sabha on Tuesday.

The vaccine is also being tried in a human trial in South Africa that started last month.

The Novavax vaccine candidate - NVX-CoV2373 - has been engineered from the genetic sequence of SARS-CoV-2, the virus that causes Covid-19.

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In preclinical studies, it elicited antibody responses to block binding of the virus’s spike protein to the cell receptors targeted by the virus, which is a critical aspect for effective vaccine protection.

Studies of this Novavax vaccine in non-human primates have shown protection against SARS-CoV-2 infection in upper airways (nasal passages) as well as protection against lower airway (lung) disease.

The trial of the fourth vaccine comes in the wake of the first two Indian vaccines demonstrating “excellent” safety results in the first phase of clinical trial following which the manufacturers started recruiting volunteers for the trial’s second phase.

The Oxford vaccine’s trials being conducted by the Serum Institute of India in partnership with the Indian Council of Medical Research is also set to restart after a pause of a week.

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“Both Bharat Biotech and Cadila have started recruiting volunteers for phase-II of their trials while the phase-1 results are being analysed. The second dose of Bharat Biotech’s vaccine and the third dose of the Cadila vaccine are yet to be administered,” Balram Bhargava, director general of the Indian Council of Medical Research said here.

The first part of the bridging study for the Oxford vaccine candidate has been completed on 100 patients followed by a week-long pause.

The Serum Institute will carry out the second part of the study on 1500 people at 14 sites once the regulatory approval comes,” Bhargava said. ICMR’s National Institute for Research in Tuberculosis is a partner in the clinical trial.

Discussions were also going on with the Russian officials for the phase-3 trial of the Sputnik-V vaccine that was launched by the Vladimir Putin administration as the world’s first vaccine against Covid-19 even without the necessary regulatory trials.

India’s Covid-19 count crossed the 49 lakh mark with the addition of 83,809 new cases. The death toll now stands at 80,776 out of which 1054 was added in the last 24 hours.