US pharmaceutical company asks FDA for emergency use of Covaxin in children
US-based biopharmaceutical company Ocugen said on Friday (November 5) that it contacted the Food and Drug Administration (FDA) for emergency use of Covaxin – a COVID-19 vaccine developed by Ocugen partner Bharat Biotech in India – for people between the ages of 18 and 20, AFP news agency reported.
However, Ocugen’s data may not be sufficient for FDA approval because it was gathered from clinical trials conducted outside of the United States on a “small group of children.”
Millions of doses of Covaxin have been administered outside the United States, notably in India, where more than 12 crore has been injected with the vaccine from Bharat Biotech.
The application for approval is based on a study carried out on 526 individuals aged 2 to 18, who received two doses of Covaxin with a gap of 28 days.
The results of this study were then compared with those of a study of 25,800 adults in India. According to the company, the comparison found “similar protection in children aged 2-18 to that shown in adults over 18.”
The trial of 526 children did not lead to any adverse events or hospitalizations.
Currently, Pfizer is the only vaccine in the United States for children under the age of 18 and recently it was approved by authorities for use in people aged 5 to 11.