Covaxin recommended for emergency use in children aged 2-18 years
Bharat Biotech’s Covaxin has received the SEC recommendation for emergency use in children between the ages of 2 to 18 years.
The Subject Expert Committee on COVID-19 has recommended emergency use of Bharat Biotech's Covaxin for children aged between 2-18 year-olds.
Bharat Biotech, the Hyderabad-based company, had submitted data from Covaxin's clinical trials on children aged between 2 to 18 years to the DCGI on October 6, 2021. The data was thoroughly reviewed by the Central Drugs Standard Control Organisation (CDSCO) and Subject Experts Committee (SEC) after which they gave positive recommendations.
Bharat Biotech has submitted data from clinical trials in the 2-18 years age group for COVAXIN (BBV152) to CDSCO. The data has been thoroughly reviewed by the CDSCO and Subject Experts Committee (SEC) and has provided their positive recommendations. pic.twitter.com/NGySZlmNXD— ANI (@ANI) October 12, 2021
The Drugs Controller General of India is yet to give final approval to Covaxin for emergency use in children between 2-18 years.
Approval to Covaxin is yet to be given by DCGI (Drugs Controller General of India) after the evaluation of Data for 2-18 years: Official sources— ANI (@ANI) October 12, 2021
When Covaxin gets emergency use approval for children between 2-18 years, it will become the second vaccine after Zydus Cadila's DNA-based vaccine ZyCoV-D, to be approved for vaccination of children in the country.
Covaxin trials on children
As per sources, the Subject Expert Committee has asserted that Covaxin is safe and effective for children. The trial results show that the safety and immunogenicity of Covaxin is almost the same in children as it is among adults aged above 18 years.
Covaxin's trial was done on three age groups- first between 12-18 years, second between 6-12 years and third age group was between 2-6 years.
At first, the trials were conducted on children in the first age group and then subsequently on other groups. The vaccine's safety was seen to be almost the same. However, the final trial results are awaited.
The World Health Organisation is yet to give its much-awaited Emergency Use Listing to Bharat Biotech's Covaxin, which is India's first indigenously developed COVID-19 vaccine.
The global health body is likely to give the authorisation soon, as it is scheduled to meet along with an independent group of experts this week to carry out the risk/benefit assessment of the vaccine and come to a final decision.
Covaxin has been developed by Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).
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