Covid-19 vaccine: Covovax gets emergency nod for 12-18 age group
The Drugs Controller General of India (DCGI) has granted emergency use authorisation (EUA) for the Novavax and Serum Institute of India (SII) Covid-19 vaccine, Covovax, in the 12-18 age group. Covovax is the fourth vaccine to receive EUA from the DCGI for use among adolescents 12 and older.
The Novavax vaccine is manufactured and marketed in India by SII under the brand name, Covovax. Novavax has a partnership with SII to source one billion doses of the vaccine. SII has already supplied close to 40 million doses of Covovax to Europe and Australia.
“The approval of Covovax for adolescents 12 and older in India marks another significant milestone in strengthening our immunisation efforts across India and low and middle income countries,” Adar Poonawalla, CEO, SII said.
According to Novavax, a Phase II and III, observer-blinded, randomised, controlled study was conducted in a total of 460 Indian adolescents aged 12 to 18 years to evaluate the safety and immunogenicity of Covovax. The study demonstrated that Covovax was well-tolerated with a reassuring safety profile and it was immunogenic in adolescents, the company said. The authorisation in India also considered the results of an ongoing pediatric expansion trial in adolescents in the US.
This is the first EUA for Novavax in the 12 to 18 age group. Novavax is also studying the efficacy, evaluating the safety and immunogenicity of Covovax for the age groups of 7 to 12 years and in 2 to 7 years age group.
Covovax is the first protein-based Covid-19 vaccine authorised for adolescents in India. Stanley C Erck, president and chief executive officer, Novavax, said apart from providing an alternative protein-based Covid-19 vaccine in India, the EUA in India would pave the way for adolescents worldwide getting an additional choice.
The vaccine is packaged in vials and contains ten doses. The vaccination regimen calls for two 0.5 ml doses given intramuscularly 21 days apart. The vaccine has to be stored at 2°-8° Celsius.
India has administered close to 100 million doses in the 12-18 age group across the country.