India starts trial of US firm's second-generation Covid vaccine

MUMBAI: A clinical study of the US-based Akston Biosciences’ second generation Covid-19 vaccine candidate has kicked off in India.

In an open-label bridging study of `AKS-452’, the protein sub-unit Covid-19 vaccine candidate, the first 100 subjects have been dosed. The AKS-452 is shelf-stable for at least six months in room temperatures (up to 25° Celsius) and maintains its potency for one month at 37° Celsius, says a release.

India’s Drug Controller General has approved the open-label bridging study being conducted by Supe Heart and Diabetes Hospital and Research Centre in Nashik, along with four other sites in Maharashtra. Ahmedabad-based Veeda Clinical Research is managing the study, it adds. The AKS-452 is a protein sub-unit vaccine, and does not contain mRNA technology, viral vectors or a weakened SARS-CoV-2 virus.

The first participants were dosed under the supervision of principal investigator Pravin Dinkar Supe, founder of the Nashik hospital. A double-blind Phase II/III study will follow with 1,500 healthy volunteers, aged 18 and above, across 12 clinical sites in five states across India.

“The highly promising results from a previous Phase II trial in the Netherlands warrant moving forward with an open-label bridging study and the Phase II/III clinical trial here in India to help speed a low-cost, temperature-resistant vaccine that can be easily manufactured, transported and stored in economically deprived countries in Africa and Asia,” said Dr Supe.

“These countries lack the infrastructure to transport and store the currently approved vaccines that require ultra-cold conditions.”

Khan also instructed the National Security Adviser to visit Afghanistan to hold delegation-level talks and agree on specific areas where immediate capacity building support shall be provided to Afghans. The meeting was attended by Foreign Minister Shah Mehmood Qureshi, Advisor on Finance Shaukat Tarin, Army Chief General Qamar Javed Bajwa, and senior civil and military officers.

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