After Zydus Cadila, the pharma firm from Gujarat that was authorised by the DCGI for its needle-free ZyCoV-D Covid-19 vaccine for children aged 12 years and above, it is learnt that the top drug regulator is likely to give approval to the Covaxin vaccine of Hyderabad-based Bharat Biotech soon for kids for emergency use.
The administration of two doses of Covaxin vaccination has been completed among children and blood samples have been sent for the third time to check the effectiveness in terms of producing antibodies among children, according to a news agency which has quoted a source in the Union Health Ministry.
A total of 90 children were subjected to Covaxin trials in Karnataka. However, the trial will take 210 days to complete. As it will take another 5 to 6 months from now, they can’t wait till then in the current circumstances to release the vaccination for children, sources added.
“Final report will come on the 210th day. The Government and DGCI can take calls any day after the 56th day of the trial Emergency use. However, the study period will be there for 210 days. Before also, while releasing Covid vaccines for adults the government of India and DCGI did not wait till the completion of 210 days. Vaccines were released earlier,” they said.
Cheluvamba Hospital in Mysuru attached to Mysore Medical College and Research Institute (MMCRI) entrusted with the conducting of Covaxin’s Clinical trials on children has sent third blood samples of children to designated laboratories.
It is one among the five medical institutes identified in the country, which had got the institutional ethics committee approvals for Covaxin’s clinical trials on children. The trials are being done in the monitoring of principal investigator and Associate Professor, department of Paediatrics Dr. Pradeep N.
The Covid vaccination trail for children comprises administration of two vaccinations between 0 and 28th day along with blood sampling. On the 56th day, there will not be vaccination but blood samples will be collected. There will be another blood sampling on the 118th and also on 210th day of the trail.
DGCI will give approvals in a phased manner first starting with children aged 12 years and above in the first phase. The approvals will be given for release of vaccines for 6 to 12 years of children and later for children aged between 2 to 6 years.