Mumbai: Registering children and adolescents in clinical trials for the Covid-19 vaccine has proven to be far more challenging for the institute than recruiting adults.
BYL NAIR Hospital in Mumbai Central can only recruit 11 teenagers for Zydus Cadila trial for children between 12 and 17 years.
The hospital initially planned to recruit 50 participants, 25 each for the vaccine and plasebo arm.
“We can’t reach that number,” said one researcher.
“Because the trial is done in more than 40 sites, we hope there will be enough participants,” expert added.
According to sources, more than 800 nationally has registered.
While someone will think parents don’t want to have their children participating in security issues, there seems to be another big reason – few who want to participate in a double blind study where no one knows if they receive vaccines or placebo.
Double blind studies are to prevent bias in the results of the study.
“People call us think their child will get a vaccine.
But when we tell them about the placebo arm that doesn’t get a vaccine, mostly back,” said Dr.
Ramesh Bharmal, the Dean of the Nair Hospital.
Although some advertisements, the Institute has received nearly 30 calls from which they recruited 11.
Zycov-D is the original DNA vaccine of three doses developed by Zydus with support from the Biotechnology Department.
Dr.
Bharmal said the trial began in July and some children also received a second dose.
There are plans now to extend the trial to children who are younger than 5-12 years, which is likely to be equally challenging, he said.
Three vaccine trials were in pipelines for children and adolescents, the Zycov-D and Bharat Biotech Covaxin, were tested in children between 2 and 18 years, closest to getting approval.
KEM and Nair Hospital will also participate in other trials for underage children aged 12-17 for Covovax.
The protein nanoparticle vaccine developed by US company NovaVax will be tested for safety and efficacy.
KEM and Nair Hospitals, who will participate in the Covovax trial, said they were awaiting the approval of the Ethics Committee.
Vaccines for children are expected to come in September.
Interestingly, investigators have different experiences while recruiting children for Covaxin.
Nagpur-based Institute, Meditrina Meditric Institute, can recruit 150 children against quota 60 in June.
Dr.
Vasant Khalatkar said they had to draw because hundreds of who wanted to participate.
The youngest participant is a two-year-old child.
Because Covaxin has been given to adults, which can give trust to parents.
“But, children also want to be a Covid warrior and are not afraid to take a shot,” he said.