India grants Novavax Covid-19 vaccine emergency use authorisation for teens

Thursday, March 24, 2022

Novavax research and development laboratories in Gaithersburg, Maryland, United States on September 24, 2020.
Image: Maryland GovPics.

On Tuesday, the Drugs Controller General of India (DCGI) granted emergency use authorisation to Novavax Covid-19 vaccine Covovax for use on teenagers aged between 12 and 17.

The vaccine, also known as NVX-CoV2373, is manufactured by the Serum Institute of India under the brand name Covovax. Last month, Novavax conducted the last stage trial of the vaccine on 2,247 Indian teenagers aged between 12 and 17, which returned an 80% efficacy rate.

Novavax also ran phase three trials of Covovax in the United States and the United Kingdom on participants aged 18 years and older, which showed an efficacy rate of 90.4% and 89.7%, respectively.

Covovax is the first protein-based subunit vaccine against coronavirus to receive authorisation in India for this age group. Last week, India started vaccinating teenagers aged between 12 and 14 using the Biological E Corbevax.

President of Novavax Stanley C. Erck commented after the decision: "we're proud of this first approval in adolescents given the efficacy and safety that our data show in this population". CEO of the Serum Institute of India Adar Poonawalla said it "marks another significant milestone in strengthening our immunisation efforts".

In December last year, DCGI approved Covovax for adults aged over 18 in India. Novavax is already listed for emergency use by the World Health Organization and authorised for emergency use in Indonesia, the Philippines and Bangladesh.