New Delhi: Screening and trial of Bharat Biotech’s Corona Vaccine Covaccine will start on children aged 2 to 6 years from June 28 in AIIMS Delhi and Patna. The children’s trial is divided into three age groups. The age limit has been fixed from 2 to 6 years, 6 to 12 years and 12 to 18 years. So far, the trial of children of 6 to 12 years and 12 to 18 years has started and the first dose has been given to them.
Bharat Biotech’s Kovid-19 vaccine trial is going on on children aged 2 to 18 years, for whether corona vaccine can be given to children below 18 years of age. The recruitment of children of 2 to 6 years will be started from Monday 28 June. After recruitment, the children will be screened and if found fit in the clinical trial, they will be included in the trial.
Sanjay Rai, Community Medicine, Delhi AIIMS, says, “They have been recruited for 12 to 18 years and 6 to 12 years, they have been given the first dose. The sample size has been achieved. Those who are 2 to 6 years of age will be screened from Monday and after the screening report comes, all the health volunteers will be vaccinated after the screening report.
Children’s trials will also be the same as adults’
- There will be a gap of 28 days between the first dose and the second dose.
- Children will also be given a dosage of 6mg.
- Antibody test will also be done before the trial.
- After getting the vaccine in the trial, they will also be continuously monitored.
- The vaccine will be given in two doses by the intramuscular route.
Bharat Biotech’s vaccine is to be trialed on about 50 children aged 2 to 18 years in the ongoing trial at AIIMS. The results of clinical trials of children will not take much time. The test will go on for a long time but its interim results can come in three months and based on that the drug controller can decide on the vaccine.
According to Dr. Sanjay Rai, “It is the same way as the dose is given to the elders. Second dose four weeks after the first dose. Monitoring will be done after giving the first and second doses because safety is to be seen, immunity is to be seen. Its data will be given to the regulatory authority. Vaccines are the same which are being given in adults now, safety and efficacy have been prescribed in adults, not in children. Interim results can be done anytime after 3 months but the trial will go on for a long time. So if need be and regulatory authority can release the vaccine on its interim result. It will take at least three months. After that, if the drug controller is satisfied, then it can come.
Like AIIMS Delhi, this clinical trial is going on in Patna AIIMS. On Monday, there will be screening and recruitment of children in the age group of 2 to 6 years in Patna AIIMS. In May this year, the country’s Drugs Controller General of India (DCGI) had given permission for the second and third clinical trials of Bharat Biotech’s corona vaccine Covaxin in children.
Center has given more than 30 crore corona vaccine doses to the states so far