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Bharat Biotech’s Covaxin recommended for use in children between 2 to 18 years, say reports

Our Bureau, New Delhi
Tuesday, October 12, 2021, 15:45 Hrs  [IST]

India’s indegenous Covid-19 vaccine Covaxin from Bharat Biotech has been recommended by the drug regulator’s Subject Expert Committee (SEC) for use among children between the age of two to 18 years. The vaccine, which has been administered in adults on or above 18 years so far, may now be the first vaccine to be used in the said age group of younger population.

According to agency reports, SEC has given a recommendation to the Drugs Controller General (India) [DCGI] for clearing the drug for the use in children between the age of two to 18.

An official declaration on the same has not yet been made.

Reports quoting sources said that the company has submitted clinical trial data for Covaxin usage among the said age group to the Central Drugs Standard Control Organisation (CDSCO).

It may be noted that the World Health Organisation (WHO) is expected to hold a meeting this week to come to a final decision on whether to grant Emergency Use Listing approval to Covaxin.

Last week, the Organisation said, "WHO & an independent group of experts are scheduled to meet next week to carry out the risk/benefit assessment and come to a final decision whether to grant Emergency Use Listing to Covaxin".

Covaxin manufacturer, Bharat Biotech, has been submitting data to WHO on a rolling basis & submitted additional info at WHO’s request on September 27.

Bharat Biotech, last month, said that the clinical trial data was fully complied and available in June 2021 and all data submitted for Emergency Use Listing (EUL) Application to WHO in early July.

“As a responsible manufacturers with several WHO prequalified vaccines, we do not find it appropriate to speculate or comment on the approval process and its timelines. However, we are continuing to work diligently on obtaining WHO EUL at the earliest,” said the company in its Twitter page. Experts have been pegging the approval to be in place by the end of September itself.

Covaxin, the two doses (Day 0 and 28) for people above 18 years of age, administered through intramuscular route, was approved by the CDSCO on January 3, 2021, along with Serum Institute of India Pvt Ltd’s Covishield, another two dose vaccine to be administered among population on or above 18 years of age.

Cadila Healthcare is the only other company which received regulatory approval for use of its recombinant DNA vaccine among children, who are at or above 12 years old.

India has so far approved eight vaccines, including Johnson & Johnson’s single dose vaccine to be manufactured by Biological E Ltd (approved on August 18, 2021) and imported by Johnson & Johnson from other sites (approved on August 7, 2021), both to be administered in population on or above 18 years.

Besides, Dr Reddys’ Laboratories was approved to import Russian vaccine Sputnik-V, through an order in April 12, 2021, and Cipla for import of Moderna’s mRNA vaccine, approved on June 29, 2021. Panacea Biotec Ltd was also approved to deal with Sputnik-V, through an order on July 2, 2021.

 

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