If approved by the drugs regulator, Bharat Biotech's Covaxin will be the second COVID-19 vaccine after Zydus Cadila's needle-free ZyCoV-D to receive EUA for use in those below 18 years.
Bharat Biotech's COVID-19 vaccine Covaxin is yet to get approval by the Drugs Controller General of India (DCGI) for emergency use authorisation in children and adolescents in the two to 18 years age group, as it is seeking additional technical opinion on it, reported Hindustan Times citing sources.
The vaccine received a recommendation Subject Expert Committee (SEC) on COVID-19 for granting emergency use authorisation earlier this week.
“The drugs controller general of India (DCGI) is taking more technical opinion on vaccinating children even though the expert panel has recommended its use,” a senior official in the union health ministry told the publication.
The official further noted, “We will have to be extremely careful when talking about COVID-19 vaccination in children as even the developed countries that have begun vaccinating their children, are treading cautiously. The whole world is watching and we cannot afford to slip.”
If approved by the drugs regulator, it will be the second COVID-19 vaccine after Zydus Cadila's needle-free ZyCoV-D to receive EUA for use in those below 18 years.
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Hyderabad-based Bharat Biotech, which completed the phase 2/3 trials of COVID-19 vaccine Covaxin for use in children aged between two and 18 years, had submitted the data to the Central Drugs Standard Control Organisation (CDSCO) for its verification and subsequent approval for emergency use authorisation (EUA) for the jab in the beginning of this month. The Subject Expert Committee (SEC) on COVID-19 examined the data and deliberated on the EUA application.
The committee noted that the interim safety data of the phase 2/3 clinical trial was reviewed in a meeting on August 26, sources said. The overall geometric mean titre (GMT) for the paediatric population is comparable with GMT of the adult population in phase -3 efficacy study, the recommendations stated.
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After detailed deliberation, the committee recommended the grant of market authorisation of the vaccine for the two to 18 years age group for restricted use in emergency situations subject to certain conditions, they stated. According to the conditions, the firm should continue the study as per the approved clinical trial protocol and provide updated prescribing information/package Insert (Pl), Summary of Product Characteristics (SmPC) and Factsheet.