COVID-19: Novavax Gets Emergency Use Authorisation For Children Aged 12-17 In India

American drugmaker Novavax's COVID-19 vaccine, developed in India by the Serum Institute of India (SII), has been given emergency-use authorisation (EUA) from the Drugs Controller General of India (DCGI) for kids of age group 12 to 17 years. The vaccine named Covovax, is the first protein-based vaccine that has received authorisation for use in this age bracket in the country. in February, Novavax had said that its vaccine was 80% effective against Covid infection in a late-stage experiment after testing the vaccine in 2,247 teenagers of age 12-17 years.

Stanley C Erck, The President and CEO of Novavax said, "We're proud of this first approval in adolescents given the efficacy and safety that our data show in this population, and that our COVID-19 vaccine will provide an alternative protein-based vaccine option for individuals 12 years of age and older in India."

On Tuesday, the company has said that its vaccine is capable of producing an immune response in the same age bracket in a mid- to late-stage study consisting of 460 Indian teens. Covovax is the fourth COVID-19 vaccine to receive authorisation for teenagers of age 12 years and above in India after Biological E's Corbevax, Zydus Cadila's ZyCoV-D and Bharat Biotech's Covaxin.

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According to a press release by Novavax, "The safety and efficacy of Covovax in adolescents aged less than 12 years have not yet been established; however, studies evaluating the safety and immunogenicity of Covovax for the age groups of ≥7 to <12 and ≥2 to <7 years in India are underway." The DCGI had given EUA for Covovax for adults of age 18 and above last year in December. Moreover, Covovax has also been given Emergency Use Listing (EUL) from the World Health Organization (WHO).

On the other hand, the registrations for administration of COVID-19 vaccine teenagers under the age group of 15-18 years started on January 1, 2022. These children were administered Bharat Biotech’s Covaxin in two doses with a gap of 28 days. Besides getting vaccinated, it is also important to keep following Covid appropriate behaviour including frequent handwashing, sanitization, social distancing and wearing masks.