Bengaluru, Aug 22: The Central government and the Drugs Controller General of India (DCGI) may give approval to the Covaxin vaccines for children soon for emergency use, sources said.
The administration of two doses of 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, sources told IANS.
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 underlined.
“Final report will come on 210th day. The government and DGCI can take calls any day after 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,” sources 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.
The DGCI might take a call for the release of Covid vaccines for the children after ensuring efficacy of vaccines through antibody titre tests, reliable sources in the health department told IANS.
The Mysuru Cheluvamba hospital 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 56th day, there will not be vaccination but blood samples will be collected. There will be another blood sampling on 118th and also on 210th day of the trail. (IANS)
