Paving the way for COVID-19 vaccination of kids, thereby leading to a safe opening of primary and secondary schools, Bharat Biotech on Thursday announced clinical trial results of Covaxin conducted on children aged 2-18 years.
Covaxin received approval for emergency use in children 12 - 18 years of age, following which, the government rolled out vaccination for kids from January 3, 2022, but for 15-18 age group.
The Hyderabad-based pharmaceutical company today further said that Covaxin has proven to be safe, well-tolerated, and immunogenic in paediatric subjects in phase II/III study. Bharat Biotech had conducted phase II/III, open-label, and multicenter studies to evaluate the safety, reactogenicity, and immunogenicity covaxin in healthy children and adolescents in the 2-18 age group.
"The clinical trials conducted in the paediatric population between June 2021 to September 2021 have shown robust safety, reactogenicity, and immunogenicity," the company said in a statement. "In the study, no serious adverse event was reported. 374 subjects reported either mild or moderate severity symptoms with 78.6% getting resolved within 1 day. Pain at the injection site was the most commonly reported adverse event," it added. The results are however yet to be peer-reviewed.
"Covaxin's clinical trial data from the paediatric population is very encouraging. Safety of the vaccine is critical for children. Covaxin has now proven data for safety and immunogenicity in children," said Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech.
In absence of vaccine choices for kids, the closure of schools has already caused learning loss among them. Bearing testimony to the fact, according to a report of UNICEF released in March 2021, in India, the closure of 1.5 million schools due to the pandemic and lockdowns in 2020 impacted 247 million children enrolled in elementary and secondary schools. In addition, there are over six million girls and boys who were already out of school even before the COVID-19 crisis began, the report had said.
Even though several schools across states including Delhi started opening after the signs of COVID-19 curve bending downsides, lakhs of parents were reluctant to send their kids to schools without vaccination. "If we are not going to reverse the decision to reopen schools all children even younger than 15 years old need to be vaccinated," said Dr Vispi Jokhi, CEO at Mumbai based Masina Hospital.
With cases of Omicron rising, the new and fast-spreading COVID-19 variant, school authorities and parents alike are willing to vaccinate their younger children. "Parents are not willing to send children to schools. Majority of classes don't see any strength of students. The first argument of parents is that they want their children to be vaccinated before sending them to schools," said a senior school teacher in government school in Delhi not willing to be named.
Meanwhile, at least 961 cases of Omicron have been reported as on Thursday and number continues to rise.
"Consistent evidence shows that the Omicron variant has a growth advantage over the Delta variant with a doubling time of 2-3 days and rapid increases in the incidence of cases is seen in a number of countries, including those where the variant has become the dominant SARS-CoV-2 variant, such as the United Kingdom and the United States of America," said Lav Agarwal, Joint Secretary at Union Health Ministry.
Further, the government data showed that 90 per cent of adult population has been inoculated with at least one dose and 63.5 per cent of the eligible population has been fully vaccinated. India's cumulative COVID-19 count has breached 144 crore-mark on Thursday.
The country's drug regulator has already approved Zydus Cadila's ZyCoV-D for those aged 12 years before Covaxin was a given a green signal for 15-18 years age group.
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Also Read: DGCI gives emergency use approval to Bharat Biotech's Covaxin for 12-18 years age group