new Delhi: India’s drug regulator, the Drugs Controller General of India (DCGI), has approved the Serum Institute of India’s (SII) COVID-19 vaccine Kovovax, subject to certain conditions, with the Emergency Use Authority (EUA) for children between the ages of 12 and 17. has provided. SII’s Covovax is a nanoparticle-based vaccine and is manufactured by transfer of technology from Novavax.
SII Chief Executive Officer Adar Poonawalla said in a tweet on Wednesday that Novovax has demonstrated over 90 percent efficacy in global trials, and SII’s brand Kovovax has completed bridging studies in India and awarded EUA by DCGI has gone. For adults and children over 12 years old. He further added that a lower age bracket would soon follow.
Novavax has demonstrated over 90% efficacy in global trials. @SerumInstIndiaThe brand Covovax has completed bridging studies in India and has been granted emergency use authorization by DCGI for adults and children above 12 years of age. Younger age groups will follow soon.
— Adar Poonawalla (@adarpoonawalla) 9 March 2022
Kovovax is the fourth vaccine to receive DCGI approval for use in people younger than 18 years old.
Last week, Subject Expert Committee (SEC) on COVID-19 According to media reports, the Central Drugs Standard Control Organization (CDSCO) has recommended giving EUA to Covovax for beneficiaries in the age group of 12 to 17 years.
However, the government has not taken any decision yet. Vaccination of children below 15 years of age.
Further, the Union Ministry of Health and Family Welfare has consistently stated that the additional requirement of vaccination and the inclusion of the population for vaccination should be continuously scrutinised.
Prakash Kumar Singh, Director (Government and Regulatory Affairs) at SII, said in an EU application to DCGI on February 21 that two studies on approximately 2707 children aged 12 to 17 years show that Kovovax is highly efficacious, immunosuppressive, safe and effective. Is. According to a report published by the Press Trust of India (PTI), it is well tolerated in this age group of children.
“This approval will not only be beneficial to our country, but will benefit the entire world, fulfilling our Prime Minister’s vision of ‘Making in India for the World’. In line with the vision of our CEO Dr. Adar C Poonawalla, we I am sure that Kovovax will play a vital role in saving the children of our country and the world at large from the COVID-19 disease and will keep our national flag high globally,” an official source said in the application, quoting Singh, of PTI. Report
Following the recommendation of an expert panel of CDSCO to grant EUA to Kovovax, subject to certain conditions, DCGI has already approved Covovax on December 28 for restricted use in emergency situations in adults. However, Covovax has not yet been included in the country’s vaccination campaign.
How does Kovovax work?
Covovax has been approved by the European Medicines Agency for conditional marketing authorization, and an emergency use list granted by the World Health Organization (WHO).
A nanoparticle-based vaccine is one in which the receptor-binding domain (RBD), which is part of the spike protein of SARS-CoV-2, binds to a protein designed to form nanometer-sized protein particles, or nanoparticles . SARS-CoV-2 attaches itself to cells using spike proteins.
Read also | Explained: As India Clears SII’s Covovax, Know What a Nanoparticle-Based Vaccine Is and How It Works
Nanoparticles help improve vaccine efficacy by targeting desired antigen-presenting cells to improve vaccination strategies. They protect antigens (foreign particles) from initial proteolytic degradation (degradation of proteins 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
DCGI on 21st February Hyderabad-based firm Biological E’s Covid-19 Vaccine Corbevax has been approved for emergency use for immunization of adolescents in the age group of 12-18 years. Biologicals E said in a statement that Corbevax has received an EUA from the DCGI for the age group 12 to 18, subject to certain conditions.
Read also | Explained: Organic E’s Corbevax Approved for ages 12-18. Here’s How the Vaccine Works
Biologicals has applied for EUA for its COVID-19 vaccine Corbevax for children aged five to 12 years, news agency ANI reported on Wednesday, March 9.
Organic E has submitted data for beneficiaries ages five to 12 to the SEC.
Read also | Biologic E to EU for Corbevax, a Covid-19 vaccine for ages 5-12, applies: report
Corbevax is India’s third indigenous COVID-19 vaccine after Bharat Biotech’s Covaxin and Zydus Cadila’s ZyCoV-D.
India is using Covaxin to vaccinate adolescents aged 15 to 18 years. In December last year, Covaxin was approved for emergency use in adolescents aged 12 to 18 years.
ZyCov-D is the first vaccine to be approved by India’s drug regulator for vaccination of people 12 years of age and above.
(with PTI inputs)
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