India will soon start clinical trials of US-based Akston Biosciences second-generation Covid-19 vaccine — one of the most promising candidates that can be rapidly produced at a low cost, suitable for repeated dosing if immunity wanes and requires no refrigeration.
The vaccine samples have been sent to the Central Drugs Laboratory in Kasauli as a protocol for checking the safety prior to starting its use in clinical trials.
The vaccine candidate — tentatively titled ‘AKS-452’ — is shelf-stable for a minimum of six months at 25°C and remains potent for a month at 37°C.
“The samples have been sent to CDL, Kasauli and trial is expected to begin in a month at around 12 sites in India,” a senior government official told News18. “The total sample size from Indian trial is around 1,600 people under phase2/phase 3 trials, which take at least a year to conclude.”
The officer further said, “India may not require the vaccine for domestic use but can manufacture this vaccine for exports and solving the problem of access to vaccines in poor and middle income countries.”
The trial is expected to start in hospitals in Maharashtra, Karnataka, Tamil Nadu, Rajasthan and Gujarat.
Ideal for Countries with Poor Storage Infra
The vaccine, if proven effective, can solve the storage issues in areas, which lack good infrastructure as the company says the vaccine candidate is shelf-stable at room temperature for at least six months and is ideal for hot countries such as Kenya because it can be transported and stored for months without refrigeration.
The company, which in August, had dosed the first subjects in a Phase II open-label clinical trial of its protein subunit Covid-19 vaccine candidate, says that “the vaccine has been engineered to use standard, low-cost, antibody manufacturing techniques, such that a single production line could be capable of producing over one billion doses per year at existing plants around the world.”
The first generation of vaccines are those which worked on the original strain of novel coronavirus such as Covishield, Covaxin and products by Pfizer-BioNTech, Moderna, Johnson & Johnson vaccines among others.
Any improvement in these vaccines such as reduction in side-effects, adaptation to the requirements of the world would lead to the creation of second- and third-generation vaccines.
According to Akston Biosciences, “The extended shelf stability, the clinical data that show a single injection of the 90μg dose provides 100% seroconversion at significantly higher titres than confirmed Covid-19-positive convalescent serum samples, and the ease of manufacturing relative to currently approved vaccines, indicate that our second-generation vaccine has the potential to more easily safeguard the health of populations worldwide against Covid.”
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