DCGI approves Kovovax vaccine for children aged 12 to 17 years

The Indian drug regulator has approved limited emergency use of the Serum Institute of India’s (SII) anti-Covid-19 vaccine ‘Kovovax’. The vaccine has been developed for children aged 12 to 17 years. SII CEO Adar Poonawalla gave this information by tweeting.

This will be the fourth anti-corona vaccine available in the country for people below the age of 18 years. The Drug Controller General of India (DCGI) has approved the emergency use of Kovavax based on the recommendation of the Subject Expert Committee on Kovid-19. The government has not yet taken any decision on vaccinating those below 15 years of age.

Novavax in global trials has demonstrated more than 90% efficacy. @SerumInstIndia‘s brand Covovax has completed bridging studies in India & has been granted Emergency Use Authorization by DCGI for adults & for children above the age of 12. Younger age groups will follow shortly.

— Adar Poonawalla (@adarpoonawalla) March 9, 2022

In an application to the DCGI, dated February 21, Prakash Kumar Singh, Director (Government and Regulatory Affairs), Serum Institute, said that two studies on approximately 2707 children aged 12 to 17 years suggest that Covovax is more effective, producing more immunity. It is a safe vaccine. It was also said that children in this age group can tolerate this vaccine well.

According to an official source, in the application, it was said on behalf of Singh that this approval will not only be beneficial for our country, but the whole world will benefit from it. It was said on behalf of Singh that, “This is in line with our Prime Minister’s vision of ‘Making in India for the world’. In line with the vision of our CEO Dr. Adar C Poonawalla, I am sure that Kovovax will play a vital role in saving the children of the country and the world at large from the COVID-19 disease.

DCGI had already approved Covovax on December 28 for limited use in emergency situations in adults. However, it has not yet been included in the country’s vaccination campaign.

The DCGI on February 21 had approved the emergency use of Biologicals-E’s anti-Covid-19 vaccine ‘Corbevax’ for the age group of below 12 to 18 years, subject to certain conditions. Kovavax is manufactured by transfer of technology from Novavax. This vaccine has been given conditional approval by the European Medicines Agency for sale in the market.

Bharat Biotech’s vaccine ‘Covaxin’ is being used to vaccinate adolescents aged 15-18 years in India. The DGCI was the first to approve the ‘Zycov-D’ vaccine for emergency use for children above 12 years of age.