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The clinical trials for pediatric use of Covaxin, in the age group of 2 to 18, is likely to be taken up soon in the United States (US). According to sources, Ocugen, the US partner of the Hyderabad-based Bharat Biotech for Covaxin, is now working on modalities for conducting the trials.
Ocugen had said last week that the US Food and Drug Administration (FDA) declined to issue an Emergency Use Authorisation (EUA) for Covaxin for active immunisation to prevent Covid-19, caused by SARS-CoV-2 in individuals aged between 2 to 18 years.
“The conduct of clinical trials in the US is a general condition for approval from the USFDA. The reason for denial of EUA for pediatric use is not due to concerns on its efficacy deficiency,” said a source. It is also learnt that Ocugen is in the process of building up additional clinical data from the United States in due course of time.
Last month, the USFDA had permitted human trials in adults for its Covid-19 vaccine, Covaxin. To get approval of the vaccine for pediatric use, the clinical data for 2-18 years age group would also need to be generated.
The approval in the US will be a significant development for Covaxin as well as India because it will be the first “Made in India” vaccine to gain access to the American market and will also be the first universal vaccine with the same dose for all age categories.
‘No impact in India’
Back home, Covaxin is being administered actively in the age group of 15-17 years, according to Bharat Biotech as nearly 8.75 crore doses have been administered so far.
“There is no impact of the denial of EUA for pediatric use of Covaxin by the USFDA in India. Only a few educated parents were curious to know as to why it was not approved there when the Indian regulator had given its nod. But there are no undue concerns on its safety and efficacy as per our feedback,’‘ a top executive of a corporate hospital told BusinessLine.
“We go by the Indian standards and have no issues in vaccinating my children with Covaxin,” said MV Rao, who accompanied his 17-year-old for vaccination at a centre here.
In December last year, the Drugs Controller General of India (DCGI) had approved Covaxin for use in children between the ages of 12 and 18.
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