India on Monday received its third Covid-19 vaccine against children with the drug regulator approving Biological E’s Corbevax for emergency use in the 12-18 years age group.
The approval from the Central Drug Standard Control Organisation comes nearly two months after the protein sub-unit vaccine received emergency use authorisation for adults on December 28.
“The CDSCO has granted emergency use authorisation to Covid-19 vaccine Corbevax for the 12-18 year age group. This will further strengthen our fight against Covid-19,” tweeted Union Health Minister Mansukh Mandaviya.
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The approval for adolescents was based on interim results of the ongoing phase II/III clinical study, the Hyderabad-based company said in a statement.
Developed in partnership with Texas Children’s Hospital and Baylor College of Medicine, Corbevax is more than 90 per cent effective against Wuhan strain and more than 80 per cent efficacious to prevent symptomatic infections. The vaccine also generated 50 per cent fewer adverse effects when compared against Covishield, the Texas Children’s Hospital said in a statement.
The vaccine candidate received generous funding support from the Union government with the Health Ministry and Department of Biotechnology providing financial assistance and technical support to the company on vaccine development.
The approval comes after the Subject Expert Committee on Covid-19 of the CDSCO on February 14 recommended granting restricted EUA to Corbevax for the 12 to 18 years age group after deliberating on Biological E's application.
Currently, Bharat Biotech’s Covaxin and Zydus Cadila’s ZyCov-D are the two other vaccines approved for use in adolescents and children up to 12 years of age. But the government used only Covaxin in its programme to inoculate more than seven crores of 15-18-year-old kids.
Corbevax is administered through the intramuscular route with two doses scheduled 28 days apart and is stored at two to eight degrees Celsius temperatures and presented as 0.5 ml (single dose) and 5 ml (10 doses) vial pack.
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