Bharat Biotech Allowed To Conduct Trials on Children Older Than 12
Bharat Biotech also received emergency approval in “clinical trial mode”.
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Vaccine maker Bharat Biotech has now been permitted to conduct its trials on children above 12 years of age, reported NDTV. It has also received emergency approval in “clinical trial mode” for its COVID-19 vaccine on Sunday, 3 January.
According to NDTV, the vaccine was already administered to children above 12 years of age, in the last round; and was held safe.
Bharat Biotech is presently conducting the third phase of the trials.
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The government, according to NDTV, had said that the vaccination drive is meant only for use by adults. However, NDTV further reported, that this latest development gives hope that, as per conditional to sufficient data, the use of Covaxin can be extended to children, as well.
The DGCI circular granting emergency use permission to Bharat Biotech also mentions that the age group as “≥ 12”.
Further, the circular says that the permission granted by the DGCI is for “restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode.”
NDTV further reported, citing Union Health Minister Dr Harsh Vardhan, that since Covaxin will be used in clinical trial mode, all its recipients will be tracked and kept an eye on, quite like how it is done in clinical trials. Thus, the emergency approval granted to Covaxin is different from the one given to Serum Insitute’s Covishield.
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