E-Paper
Govt’s expert committee to review Covovax data for 2-12 yr olds today
The company sought approval in the form of two separate applications submitted on March 16 and June 1 with trial data of children aged seven to 12 and two to seven years respectively.
The drug regulator’s subject expert committee is likely to review on Friday, Serum Institute of India’s application for an emergency use authorization to Covid-19 vaccine Covovax for children aged 2-12, according to people familiar with the matter.
Covovax is already approved in India for emergency use in children aged between 12 and 18, and is currently being administered to those over the age of 15.
The company sought approval in the form of two separate applications submitted on March 16 and June 1 with trial data of children aged seven to 12 and two to seven years respectively.
In its previous meeting, on April 29, this year, the subject committee of the Central Drugs Standard Control Organization sought more data from the company.
The Drug Controller General of India, the head of drugs regulator CDSCO approved Covovax for restricted use in emergency situations in adults on December 28, 2021, and in the 12 to 17 years age group on March 9, with certain conditions.
Serum Institute of India locally manufactures Covovax. It is the second anti-Covid vaccine manufactured by the company after Covishield, and has been developed by US-based Novavax Inc.
In August 2020, Novavax announced a licence agreement with SII for the development and commercialisation of NVX-CoV2373, its Covid-19 vaccine candidate, in low and middle-income countries.
The vaccine is the only one apart from those developed on the mRNA platform that demonstrate an efficacy of more than 90% against the original Sars-Cov-2 virus, according to the company.
A Phase 2/3, observer-blinded, randomized, controlled study in a total of 460 Indian adolescents aged 12 to 18 years was conducted to evaluate the safety and immunogenicity of Covovax. The study demonstrated that Covovax was well-tolerated with a reassuring safety profile. Furthermore, the data indicated that Covovax is immunogenic in adolescents aged 12 to 18.
Close to 40 million doses of Covovax have already been exported to countries where the vaccine has regulatory approvals in place.
India began inoculating children aged 15-18 from January 3, this year, and those aged 12-15 from March 16.
