The Drugs Controller General of India (DCGI) on Tuesday has approved Serum Institute’s COVID-19 vaccine Covovax for restricted emergency use in children aged 7 to 11 years subject to certain conditions.
The drug regulator board of India, DCGI gave clearance to the SII’s COVID-19 vaccine Covovax for restricted emergency use for children between the age group of 7 and 12 years. The agency’s nod for restricted emergency use came after the subject expert committee on Covid-19 of the CSDCO recommended emergency use authorization to Covovax last week for the children of the concerned age group.
The Drugs Controller General of India (DCGI) also approved India’s first indigenously developed mRNA vaccine against COVID-19, manufactured by Gennova Biopharmaceuticals for restricted emergency use for those aged 18 years and above.
On March 16, Prakash Kumar Singh, director of government and regulatory affairs at the Serum Institute of India (SII), submitted a request to the DCGI in this respect. The expert panel had sought the Pune-based company for more information regarding the application during its most recent meeting in April this year.
The regulatory authority had approved Serum Institute‘s Covovax for restricted emergency use in adults on December 28 last year and in the 12-17 age group on March 9 this year, subject to certain conditions.
India started inoculating children between 12 and 14 on March 16. Healthcare workers received vaccinations as part of the initial phase of the nationwide vaccination campaign, which began on January 16, 2021. Front-line employees began receiving vaccinations on February 2 last year.
According to the Serum Institute website, Covovax is a recombinant spike protein nanoparticle vaccine that has until today been approved for use on individuals 12 years of age and older. It is administered intramuscularly twice, with a three-week interval between each injection. For younger children, it is unclear, though, if the gap will remain the same.
India launched a vaccination drive for all people aged 45 years and above from April 1, 2021. Then, the government widened its vaccination drive campaign by allowing everyone above 18 years of age to be inoculated against the viral disease from May 1, 2021.
