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Serum Institute gets nod for Novavax vaccine trial in 7-11 age group

Our Bureau | Updated on September 29, 2021

A representative image   -  REUTERS

It is packaged as a ready-to-use liquid formulation in a vial containing ten doses.

Against the backdrop of children returning to school, the Serum Institute of India has received the green signal to conduct trials on the Novavax vaccine in children in the 7 to 11 age group.

The Drug Controller General of India has given its go-ahead for the trial, a source told BusinessLine. Serum Institute has an alliance with American company Novavax to make and market its vaccines in low and middle-income countries.

Serum presently is undertaking a trial on the Novavax vaccine in children in the 12 -17 age group, adding to the portfolio of vaccines being developed for children and adolescents, including Bharat Biotech’s Covaxin, Johnson and Johnson’s single-dose vaccine, and the needle-free DNA vaccine from Zydus Cadila. The Zydus vaccine is, in fact, poised for launch, as decisions are awaited on its pricing and eventual roll-out across the country.

Inoculation target

The Novavax vaccine is part of the government’s vaccination plan to get 100 crore people inoculated by the year-end. And recently, Serum’ Chief Executive Adar Poonawalla had told media persons that the raw material shortages from the United States had eased, and the company was hoping to outline its production schedule shortly. He was hopeful that the child vaccine could be ready for approval, possibly by early next year.

Last week, Novavax and Serum said they had filed for an emergency use listing on the vaccine with the World Health Organization. The Novavax vaccine is a recombinant nanoparticle protein-based Covid-19 vaccine with Matrix-M™ adjuvant. The submission to WHO was based on the companies' previous regulatory submission to the Drugs Controller General of India (DCGI).

Novavax and SII have cumulative commitments to provide more than 1.1 billion doses to the WHO-supported COVAX facility.

The EUL by the WHO is a prerequisite for exports to numerous countries participating in the COVAX facility, established to allocate and distribute vaccines equitably to participating countries and economies. “In addition to the submission for WHO EUL, SII and Novavax last month completed the submission of modules required by regulatory agencies in India, Indonesia and the Philippines for the initiation of a review of the vaccine, including preclinical, clinical, and chemistry, manufacturing and controls (CMC) data, Novavax said recently.

Novavax' Covid-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination involves two 0.5 ml doses given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels, according to the company.

Published on September 28, 2021

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