Covaxin approved for emergency use in 2–18-year-olds

The Subject Expert Committee on Covid-19 has approved the “emergency use” of Bharat Biotech’s Covaxin vaccine for children aged between 2-18 years old.

Key Points

  • Phase-2 and Phase-3 trials of the Covaxin vaccine by Hyderabad-based Bharat Biotech on children below the age of 18 years in the months of September.
  • Trial data was submitted to the Drugs and Comptroller General of India (DCGI) in October 2021.
  • According to AIIMS professor, latest trials suggests that safety and immunogenicity of India’s indigenous COVID-19 vaccine is almost the same in children aged 2-18 years, as it is in adults above 18-years of age.
  • Trial was done by diving children into three groups. The first group was between 12 -18 years, second group was between 6- 12 years while the third age group was between 2-6 years.

About Covaxin

Covaxin is codenamed as BBV152. It is an inactivated virus-based COVID-19 vaccine. It was developed by Bharat Biotech in association with the Indian Council of Medical Research (ICMR). Vaccine is usually considered effective if the estimate is more than 50% with a more than 30% lower limit of the 95% confidence interval. Bharat Biotech reported the Covaxin is 64 percent effective against asymptomatic cases, 78% effective against symptomatic cases, 93% effective against severe infection while 65% effective against the Delta variant of coronavirus.

How Covaxin was developed?

Covaxin uses a traditional technology which is similar to inactivated polio vaccine. In the initial phase, sample of SARS-CoV-2 was isolated by National Institute of Virology, India. Then this sample was used to grow large quantities of virus using the vero cells. Following this, viruses were soaked in beta-propiolactone, in order to deactivate them by binding to their genes. Resulting inactivated viruses were then mixed with aluminium-based adjuvant Alhydroxiquim-II.

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