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Karnataka’s Covid fight gets boost with nod for Covaxin trials on children at five sites across state

Nandita Vijay, Bengaluru
Tuesday, June 1, 2021, 08:00 Hrs  [IST]

The Karnataka government’s fight against Covid has got a booster shot as it received the consent to conduct Covaxin trials on children. The trials of Covaxin for phase 2 and 3 on children aged between 12 and 18 will be followed by those aged from 6 to 12 years and thereafter children between 2 to 6 years will be brought for the human study.

Mysuru’s government-owned Chelvumba Hospital is among the five sites across the state selected for the study. This oldest medical centre in the district is attached to the Mysore Medical College and Research Institute (MMCRI).

The Drugs Controller General of India (DCGI) has approved Bharat Biotech’s application to test the vaccine on below 18 years. In fact, Chelvumba Hospital is known for its expertise in conducting several vaccine trials that are now under the national immunization protocol for children, said Dr C P Nanjaraj, dean and director, MMCRI.

Those children aged between 6 and 12 will be held at the Chelvumba Hospital, said Dr H B Shashidhar, member secretary of the ethical committee at the Chelvumba Hospital, adding that Dr Prashanth and Dr Pradeep have been appointed as the principal investigators. The number of subjects are yet to be fixed.

In another development, Karnataka was in talks with 2 responses to its global vaccine tender from medical supply distributors for Sputnik V which stands canceled. Dr Reddy’s Laboratories issued a joint statement with the Russian Direct Investment Fund (RDIF) stating it is the sole distributor for the first 250 million doses of the Russian Covid-19 vaccine, Sputnik V in India.

Following this the state government said that the global tender is annulled. The government also noted that while it was ready to float the global tender for Sputnik, two medical supply distributors: Bengaluru-based Thulasi Systems and Mumbai’s Bulk MRO Industrial Supply which is a US government-registered vendor evinced interested. While the former had offered to start supply in 30 days, the latter consented to commence delivery of the first batch of Sputnik V within two weeks of receiving the order.

In fact, Karnataka is among the many states that have floated global tender to procure vaccines. So far, none of the states have been able to firm up on the procurement.

Russian Direct Investment Fund (RDIF, Russia's Sovereign Wealth Fund) developed Sputnik V is the third vaccine in the country to seek regulatory clearances after Serum Institute’s Covishield and Bharat Biotech’s Covaxin.

It was early this year that Dr Reddy’s had applied for restricted emergency use authorisation for Sputnik V. In point of fact, RDIF had inked a slew of deals apart from Dr Reddy with pharma companies like Strides, Gland Pharma and Panacea to ensure quick access to its vaccine.


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