Serum Institute has received approval from India’s drug regulator to enroll children between 7 and 11 years in Novavax’s (NASDAQ: NVAX) COVID-19 vaccine study. This comes as the South Asian country prepares to have children protected from COVID-19.
India has so far administered over 870 million COVID-19 vaccine doses in adults for its $1.4 billion population.
India’s drug regulator approves study of Novavax’s COVID-19 study in children
The Central Drugs Standard Control Organisation said, “After detailed deliberation, the committee recommended for allowing enrolment of subjects of 7 to 11 years of age group as per the protocol.”
Serum Institute is already carrying the study of its coronavirus vaccine Covovax in children between 12 and 17 years. Covovax is a domestically manufactured version of Novavax’s vaccine. Already Serum Institute has published safety data for the first 100 participants in the study.
Indian health officials have yet to give their approval to the Novavax vaccine. However, Adar Poonawalla, the director of the Serum Institute, indicated earlier this month that he expects Covovax to receive authorization for people under the age of 18 in January or February 2022.
Only the DNA COVID-19 vaccine from pharma Zydus Cadila has gotten emergency use authorization in India for adults and children above 12 years. However, the DNA vaccine is yet to launch in the country because of pricing and supply issues.
Equally, Bharat Biotech has finalized COVAXIn studied on children, and the company is currently analyzing data.
Novavax applies for Emergency Use approval
Novavax and Serum announced last week that they had submitted to the World Health Organization for an Emergency Use Listing (EUL) of their COVID-19 vaccine. The approval is required before the vaccine can be exported.
COVAX, a worldwide vaccine distribution program backed by the WHO, has received pledges from Novavax and SII to distribute more than 1.1 billion doses.
