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Covaxin trials to start among minors

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Trials of Covaxin, India’s indigenously-manufactured COVID-19 vaccine candidate, are set to begin among young people to test its immunogenicity, reactogenicity, and safety.

Trials among those aged between twelve and eighteen years are set to commence across five institutes throughout India. The institutes in question are the All India Institute of Medical Sciences (AIIMS) in Bihar state capital Patna; the Meditrina Institute of Medical Sciences in Nagpur, Maharashtra; the Mysore Medical College and Research Institute (MMCRI) in Mysore, Karnataka; Prakhar Hospital in Kanpur, Uttar Pradesh; and the Pranaam Hospital in the Madeenaguda neighbourhood of Telangana state capital Hyderabad.

Covaxin, developed by Bharat Biotech in conjunction with the Indian Council of Medical Research (ICMR), is one of three vaccines approved for use in India alongside Covishield – manufactured by the Serum Institute of India (SII) under license from AstraZeneca – and Sputnik-V, manufactured in Russia. As the country battles a virulent second wave of COVID-19, these vaccine candidates will form crucial bulwarks of the country’s response as it seeks to scale up vaccine production with a goal of producing at least two billion doses between August and December of this year. 

However, the Government’s goal of inoculating 1.08 billion Indians by December has come under scrutiny as the pace of shots administered has plateaued since a peak of four million doses in a single day earlier this year. Now, the pace is around three million doses a day with 4.15 percent of the eligible population – translating to more than 215 million doses delivered – inoculated as of May 31st. 

This has not stopped plans to test the efficacy and safety of Covaxin among the 12-18 age demographic, divided into three age brackets: those aged two to six years, those aged six to twelve years and those aged twelve to eighteen years. At the Meditrina Institute of Medical Sciences, sources told that more than 150 volunteers have been selected – approximately fifty for each subgroup. 

The decision to test among this age group comes as Bharat Biotech announces plans to scale up vaccine production. Almost 25 crore vaccine doses are expected to be available by August. “Yesterday, SII in a letter mentioned that they will be manufacturing 10-12 crore of vaccine doses, which is almost fifty percent ramping up [of their capacity] by June-end,” said Dr N. K. Arora, chairman of the COVID-19 working group under National Technical Advisory Group on Immunization (NTAGI). “Similarly, Covaxin is also going to increase its production and by July-end they will also produce between 10-12 crore doses (per month).” 

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