Serum Institute seeks Covovax EUA for 7- to 11-year age group

Pune-based vaxmaker conducting trials on children aged 2 yrs and above

Pune-based Serum Institute of India (SII) has sought emergency-use authorisation (EUA) for its Covovax vaccine from the drug regulator for children aged between seven and 11 years, said sources in the know. If the approval comes through, this will be a global first for the vaccine for such an age group.

“SII has submitted the interim data from the clinical trials and sought EUA for the Novavax vaccine it manufactures in India under the name Covovax,” said a source close to the development.

SII withheld comment till the time of going to press. Earlier this month, SII had received the Drugs Controller General of India’s (DCGI’s) approval for Covovax for children aged 12-17 years.

Novavax, had said on Wednesday that its Covid vaccine got the DCGI green light. In December 2021, the DCGI had approved the vaccine for use in adults.

Covovax is the fourth Covid vaccine to be authorised for adolescents aged 12 years and beyond in India after Zydus Lifesciences’ ZyCoV-D, Bharat Biotech’s Covaxin, and Biological E’s Corbevax.

Last month, US major Novavax had said its vaccine was 80 per cent effective against Covid in a late-stage trial testing the shot in 2,247 children aged 12-17 years. In India, SII is conducting trials of Covovax on children as young as two years and above, and thus, it aims to position the vaccine as a children’s vaccine, informed sources.

Covovax, however, has not been procured by the Centre so far for the 12-14 age group. The Union health ministry is using the Biological E vaccine Corbevax for 12-14 years and Bharat Biotech’s Covaxin for 15-17 years. Although approved, both Covovax and ZyCoV-D are not used by the Centre on adolescents yet.

SII, meanwhile, has urged the government to include Covovax in the national Covid immunisation drive for 12 years and beyond.

“SII has written to the Union health ministry, urging it to use the vaccine on adolescents in the government programme. The company has also indicated that it has received queries from several institutions, schools, hospitals, and public sector undertakings to administer the vaccine, and is looking to price it at Rs 900 per dose (excluding goods and services tax) in the private market,” indicated a source.

The company is also keen to supply to the public immunisation drive, but has not indicated any price for supplying to the Centre. SII has written a letter to Union Health Secretary Rajesh Bhushan, saying it is awaiting the health ministry’s directives for supply of Covovax to the Government of India.