Chandigarh: No Adverse Event Reported In Covovax Trials On 12 To 17 Year Age Group

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CHANDIGARH : Not a single adverse event has been reported in Covovax trials conducted at PGI on children between 12 and 17 years of age. Next in line are trials on children in two to six year age group. Safety data has to be approved by the Drug Controller General of India (DGCI) to start the trials. There are a total of 128 children in this group at all sites.

“There was no adverse event for the 12 years and 17 years of age group at our sites,” said Prof Madhu Gupta, principal investigator for the study in PGI.

PGI is one of the trial centres for Covovax, which shall be phase 2/3 observer blind randomised control study to determine the safety and immunogenicity of Covovax in children aged between two and 17 years. The study, sponsored by the Serum Institute of India (SII), will have 100 participants.

The children will be followed up for six months after being administered two shots of Covovax after a gap of 21 days. The SII has partnered with Novovax, which has been branded as Covovax in India.

No Nasal vaccine trial for children is being conducted in the country. However, ZyCoV-D vaccine has received approval for restricted use in emergency setting by the national regulator–DCGI for the 12 years and above age group, based on interim clinical data of Phase III clinical trial conducted in the country.

The interim phase II/III clinical trial data of Covaxin on healthy volunteers aged two to 18 years submitted by Bharat Biotech was deliberated on in the meeting of the subject expert committee. The committee recommended grant of market authorisation for the two to 18 year age group for restricted use in emergency situation subject to various conditions. This recommendation is being examined and additional information has been requested at the level of the Central Drugs Standard Control Organisation (CDSCO).

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