Karnataka reported 67 adverse events following immunisation (AEFIs) (in adults and children) as per the Co-WIN portal from January 3 -- when paediatric vaccination for the 15-17 years age group was rolled out -- to January 6. At least eleven of these AEFIs were mild to moderate in nature in children aged 15-17 years who suffered chills, dizziness and syncope (brief loss of consciousness).
On January 3, a total of 16 AEFIs were reported in the state. "Out of these, six to seven AEFIs that were mild to moderate, were in the 15-17 year age group," said State Health Commissioner D Randeep.
On the same day, Ballari DHO Dr HL Janardhan said three minor AEFIs were reported in children in Ballari district: two in Hospet and one in Siruguppa. "The children experienced dizziness, and chills," he said.
On January 4, total AEFIs reported were 16, on January 5, 14 were reported, and on January 6, total AEFIs reported were 21. BBMP Reproductive and Child Health Officer Dr Sudarshan said four AEFIs among children have been reported till January 6. "They were all syncopal attacks and minor in nature," he said.
At Rainbow Children's Hospital in the city, a 17-year-old girl had a syncope attack on January 3. A hospital representative said, "Her BP was 90/50 but she was dehydrated. She consulted a paediatrician and was fine later."
In Haveri district, district immunisation officer Dr Jayanand said four AEFIs have been reported in children till January 6. "Two were reported from Byadgi taluk, one from Hirekerur taluk, and another from Ranebennur. Most of them were girls. While two fainted, another two had muscle cramps. They were kept in the hospital by the paediatrician for observation and later sent home," he said.
On being asked about the lack of WHO’s emergency use listing for Covaxin for use in children, a Bharat Biotech representative said, "We never said so (that they do have approval). We got our WHO approval (for adults) on November 3, 2021. Did we start vaccination for adults post-November 3 only? Each country can take their own call with data of safety and efficacy, and Covaxin has data openly put out in 14 peer-reviewed journals."
However, the paediatric trial results for Covaxin are yet to be published in a peer-reviewed journal and are only available in a pre-print server.
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