tds_animation_stack India 30-Year-Old Delhi Man Suffered No Immediate Side Effect; Pune Firm Seeks Permission...

30-Year-Old Delhi Man Suffered No Immediate Side Effect; Pune Firm Seeks Permission for Trial on 1,600 Participants

COVID Vaccine Latest News: A day after India’s first homegrown vaccine, COvaxin, was administered to a 30-year-old Delhi-based man, no immediate side effect has been reported. The man will be under close monitoring for the next seven days. On Saturday, a few more participants were given the vaccine at AIIMS. Also Read – COVID-19 Vaccine India: 30-year-old Man Given First Shot of Bharat Biotech’s Covaxin

Pune’s Serum Institute of India (SII), which has partnered with AstraZeneca for manufacturing the Oxford vaccine candidate for COVID-19, has sought permission from the Drugs Controller General of India (DCGI) for conducting phase 2/3 human clinical trials of the potential vaccine. Also Read – COVID-19 Vaccine: Here is a List of Promising Indian Coronavirus Vaccines That May Give us Good News Very Soon

This firm aims at mass-producing the Oxford vaccine next year, which will be priced at below Rs 1,000. Also Read – Vaccine Tomorrow? Mysterious Tweet by Lancet Editor Excites Netizens, Spirals Hopes on COVID-19 Cure

“According to the application, it would conduct an observer-blind, randomised controlled study to determine the safety and immunogenicity of ‘Covishield’ (COVID-19) in healthy Indian adults. The firm said that around 1,600 participants of more than 18 years would be enrolled in the study,” a source said.

Initial results of the first two-phase trials of the vaccine conducted in five trial sites in the UK showed it has an acceptable safety profile and homologous boosting increased antibody responses, the source said.

To introduce the vaccine, the Pune firm has signed an agreement to manufacture the potential vaccine developed by the Jenner Institute (Oxford University) in collaboration with British-Swedish pharma company AstraZeneca.

These vaccines will be for India and middle and low-income countries across the world (GAVI countries).

The firm plans to start phase 2 and 3 human trials in India in August.

Oxford University on Monday announced satisfactory progress with the vaccine, making it one of the leading ones among the dozens of vaccine candidates being developed around the world.

(With agency inputs)



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