Hyderabad-based vaccine maker Bharat Biotech announced on December 30 that COVID-19 vaccine was found safe, immunogenic for the 2-18 year old age group during clinical trials.
Citing data from the phase 2, 3 clinical trials, the company said in a statement that neutralising antibodies in children, on an average, were found to be 1.7 times higher than in adults.
The multi-centre study was done across six hospitals in India and all children received two 0.5mL doses of Covaxin, which is the same formulation indicated in adults, the company said. A total of 526 children were enrolled into Group 1 (ages 12 through 18 years, n=176), Group 2 (ages 6 through 12 years, n=175), Group 3 (ages 2 through 6 years, n=175).
A total of 374 subjects reported either mild or moderate severity symptoms, with 78.6 percent getting resolved within a day.
The Whole-Virion inactivated SARS-CoV-2 vaccine has proven to be safe, well-tolerated and immunogenic in paediatric subjects, the company said.
Frequently Asked Questions
A vaccine works by mimicking a natural infection. A vaccine not only induces immune response to protect people from any future COVID-19 infection, but also helps quickly build herd immunity to put an end to the pandemic. Herd immunity occurs when a sufficient percentage of a population becomes immune to a disease, making the spread of disease from person to person unlikely. The good news is that SARS-CoV-2 virus has been fairly stable, which increases the viability of a vaccine.
There are broadly four types of vaccine — one, a vaccine based on the whole virus (this could be either inactivated, or an attenuated [weakened] virus vaccine); two, a non-replicating viral vector vaccine that uses a benign virus as vector that carries the antigen of SARS-CoV; three, nucleic-acid vaccines that have genetic material like DNA and RNA of antigens like spike protein given to a person, helping human cells decode genetic material and produce the vaccine; and four, protein subunit vaccine wherein the recombinant proteins of SARS-COV-2 along with an adjuvant (booster) is given as a vaccine.
Vaccine development is a long, complex process. Unlike drugs that are given to people with a diseased, vaccines are given to healthy people and also vulnerable sections such as children, pregnant women and the elderly. So rigorous tests are compulsory. History says that the fastest time it took to develop a vaccine is five years, but it usually takes double or sometimes triple that time.
The clinical trials conducted in the paediatric population between June-September 2021 have shown robust safety, reactogenicity, and immunogenicity.
Pain at the injection site was the most commonly reported adverse event, the release said.
Krishna Ella, Chairman and Managing Director, Bharat Biotech, said, "Covaxin's clinical trial data from the paediatric population is very encouraging."
He further added that, "Safety of the vaccine is critical for children and we are glad to share that Covaxin has now proven data for safety and immunogenicity in children. We have now achieved our goal of developing a safe and efficacious COVID-19 vaccine for adults and children."
Recently, PM Narendra Modi in his national address on December 25 announced that India will start vaccinating kids aged above 15 years from January 3, 2022.
A day later, the Drugs Controller General of India (DCGI) granted emergency use authorisation to indigenously-developed Bharat Biotech's Covaxin for children above 12 years with certain conditions.
It is the second vaccine to receive the regulator's nod for use among those below 18 years after Zydus Cadila's needle-free COVID-19 vaccine ZyCoV-D.
"The prioritization & sequencing of this precaution dose would be based on the completion of 9 months from the date of administration of 2nd dose reads the guidelines," the health ministry said while releasing its guidelines.
"Covid vaccination of children in the age group of 15-18 years to be started from 3rd January 2022. For such beneficiaries, vaccination option would be Covaxin only," the guidelines stated.
Meanwhile, India's tally of the highly contagious Omicron variant of COVID on Thursday crossed 1,000 on the back of Maharashtra reporting its highest single-day infection with the new strain. The country reported 16,764 coronavirus cases as of December 31.The cumulative number of COVID-19 vaccine doses administered in the country crossed 144.45 crore on Thursday, the Union Health Ministry said. More than 59 lakh doses were administered in the day till 7 pm, it said. The daily vaccination tally is expected to increase with the compilation of final reports for the day by late night, the ministry said.