The Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization will take a call on Bharat Biotech’s paediatric Covid-19 vaccine on Monday.
The drug regulators gave the nod to Bharat Biotech to conduct trials on children in May this year and they were completed in September. After analysing the Phase 2/3 clinical trial data of Covaxin for children, it was submitted to the Drugs Controller General of India on October 6. In the trials, Covaxin was administered to 525 children in the 2-18 age group.
If approved by the DCGI, the paediatric Covid-19 vaccine for children above 2 years of age will be available soon.
Pre-filled Syringe Vaccine
Unlike the Covaxin for adults and other Covid-19 vaccines currently being administered that are available in multi-dose vials, the paediatric Covaxin will use a pre-filled syringe or PFS mechanism. Pre-filled syringes are known to have a high-level accuracy, which makes them safer to use.
The vaccine dosage for children would be 0.5ml, the same as for adults. However, when administering vaccines to children, the accuracy of the dose is crucial.
Administering vaccines from vials to syringes can at times be inaccurate, resulting in the dose being less or more than 0.5ml, which is the recommended dose.
In the case of children as young as 2 years, a high dosage could be problematic and therefore, a PFS mechanism has been sought for the paediatric vaccine, a source in the know told CNN-News18. One pre-filled 0.5 ml of vaccine is to be used once and discarded.
Children will receive two doses of the vaccine separated by 28 days. As for adults, the government recommends a gap of 4-6 weeks between two shots.
While paediatric Covaxin is the same vaccine as Covaxin for adults, separate trials were required to ensure that the vaccine is also safe for children even though it has been approved for 18-plus age group since the beginning of the year.
Other vaccines for kids
Zydus Cadila’s three-dose needle-free vaccine ZyCov-D was approved in August for emergency use and can be given to both adults and adolescents aged 12 and above. The vaccine, however, is yet to be made available on the market.
Serum Institute of India (SII) has also recently started conducting clinical trials in 7-11 age group for their Novavax vaccine, known as Covovax in India.
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