SII's Covovax Gets Emergency Approval For Children Aged 12-17 Years

India's drug regulator, the Drugs Controller General Of India, has granted restricted EUA to SII's COVID-19 vaccine Covovax for children aged 12 to 17 years, subject to certain conditions.

SII’s Covovax is a nanoparticle-based vaccine and is manufactured by technology transfer from Novavax. | Representative Image: Getty

New Delhi: India's drug regulator, the Drugs Controller General Of India (DCGI), has granted restricted emergency use authorisation (EUA) to Pune-based firm Serum Institute of India's (SII) Covid-19 vaccine Covovax for children aged 12 to 17 years, subject to certain conditions. SII’s Covovax is a nanoparticle-based vaccine and is manufactured by technology transfer from Novavax.

Adar Poonawalla, Chief Executive Officer of the SII, said in a tweet on Wednesday that Novovax in global trials has demonstrated more than 90 per cent efficacy, and that SII's brand Covovax has completed bridging studies in India and has been granted EUA by the DCGI for adults and for children above the age of 12. He further said that younger age groups will follow shortly.

Novavax in global trials has demonstrated more than 90% efficacy. @SerumInstIndia's brand Covovax has completed bridging studies in India & has been granted Emergency Use Authorisation by DCGI for adults & for children above the age of 12. Younger age groups will follow shortly.

— Adar Poonawalla (@adarpoonawalla) March 9, 2022

Covovax is the fourth vaccine to receive the DCGI’s nod for use among those below 18 years of age. 

Last week, the Subject Expert Committee (SEC) on Covid-19 of the Central Drugs Standard Control Organisation (CDSCO) recommended granting EUA to Covovax for beneficiaries aged 12 to 17, according to media reports.

However, the government has still not taken a decision on vaccinating children aged below 15 years. 

Moreover, the Union Ministry of Health and Family Welfare has consistently said that the additional need for vaccination and the inclusion of population for vaccination be examined constantly.

Prakash Kumar Singh, director (government and regulatory affairs) at SII, said in the EUA application to the DCGI on February 21 that the data from two studies on about 2707 children aged 12 to 17 years show that Covovax is highly efficacious, immunogenic, safe and well tolerated in this age group of children, according to a report published by the Press Trust of India (PTI). 

"This approval will not only be beneficial for our country alone, but will benefit the entire world, fulfilling our prime minister's vision of 'making in India for the world'. In line with the philosophy of our CEO, Dr Adar C Poonawalla, we are sure that Covovax will play an important role to protect children of our country and world at large against COVID-19 disease and will keep our national flag flying high globally," an official source quoted Singh as having stated in the application, according to the PTI report.

After an expert panel of the CDSCO recommended granting EUA to Covovax with certain conditions, the DCGI already approved Covovax for restricted use in emergency situations in adults on December 28. However, Covovax has not yet been included in the country's vaccination drive.

How Does Covovax Work?

Covovax is approved by the European Medicines Agency for conditional marketing authorisation, and has been granted emergency use listing by the World Health Organization (WHO). 

A nanoparticle-based vaccine is one in which the receptor-binding domain (RBD), which is a part of the spike protein of SARS-CoV-2, is attached to a protein designed to form nanometre-sized protein particles, or nanoparticles. SARS-CoV-2 attaches itself to cells using the spike protein.

Nanoparticles help improve vaccine efficacy, by targeting desired antigen-presenting cells to improve immunisation strategies. They protect the antigen (foreign particle) from early proteolytic degradation (degradation of protein by hydrolytic enzymes), control antigen release, and facilitate antigen uptake.

The Covovax vaccine, which is based on Novavax, will work by teaching the immune system to make antibodies to the spike protein on SARS-CoV-2.

Status Of Other Covid-19 Vaccines In India

On February 21, the DCGI granted emergency use approval to Hyderabad-based firm Biological E's Covid-19 vaccine Corbevax for inoculating adolescents aged 12-18 years. Biological E said in a statement that Corbevax has received EUA from the DCGI for the 12-to-18 age group, subject to certain conditions.

Biological E has applied for EUA for its COVID-19 vaccine Corbevax for children belonging to the age group of five to 12, news agency ANI reported on Wednesday, March 9. 

Biological E has submitted the data to the SEC for beneficiaries between five to 12 years of age.

Corbevax is India's third indigenous Covid-19 vaccine after Bharat Biotech’s Covaxin and Zydus Cadila's ZyCoV-D. 

India has been using Covaxin to vaccinate adolescents aged 15 to 18 years. In December last year, Covaxin received approval for emergency use in adolescents aged 12 to 18.

The first vaccine to be cleared by India's drug regulator for inoculation of those aged 12 years and above is ZyCov-D.