Bharat Biotech, which completed the Phase 2/3 trials of COVID-19 vaccine Covaxin for administering under 18 years of age, has submitted the data to the Central Drugs Standard Control Organisation for its verification and subsequent approval for Emergency Use Authorisation for the jab, company sources said on Wednesday. "Covaxin clinical trial data of 2-18 years age group has been submitted to CDSCO... This is feasible due to the safety of the manufacturing platform and empirical evidence from Phase 1, 2 and 3 clinical trials in adults," sources told PTI.
Chairman and Managing Director of Bharat Biotech International Ltd, Krishna Ella, had said on September 21 that the Paediatric Covaxin completed phase 2/3 trials with about 1,000 subjects and the data analysis was going on.
As part of the Phase 2/3 trial, the two-dose Covaxin was administered with 28 days apart. "We will be submitting the data (to the regulator) by next week," he had said. He also had said that Phase 2 trials of intranasal vaccine to prevent COVID-19 were going on and expected to be over in October. If approved, Covaxin will be the first COVID-19 vaccine that can be administered to children in India.
Meanwhile, the World Health Organisation is set to take a decision on granting Emergency Use Listing (EUL) status for Bharat Biotech's COVID-19 vaccine Covaxin next week, the global health body said on Tuesday, October 5. "WHO & an independent group of experts are scheduled to meet next week to carry out the risk/benefit assessment and come to a final decision whether to grant Emergency Use Listing to Covaxin," the global health body tweeted.
The Strategic Advisory Group of Experts on Immunization (SAGE) of the WHO met on Tuesday to make its recommendations on Covaxin on EUL, among other issues.
Covaxin manufacturer, Bharat Biotech, has been submitting data to WHO on a rolling basis & submitted additional info at WHO's request on 27 September. WHO experts are currently reviewing this info & if it addresses all questions raised, WHO assessment will be finalized next week, WHO said in a series of tweets.