E-Paper
Covaxin generates 'better immune response' in children than adults: Lancet study
Covaxin, the Hyderabad-based Bharat Biotech’s anti-Covid vaccine, is safe and generates greater immune response in children than adults, show paediatric study data between age group of 2-18 years published in The Lancet.
Covaxin, the Hyderabad-based Bharat Biotech’s anti-Covid vaccine, is safe and generates greater immune response in children than adults, show paediatric study data between age group of 2-18 years published in The Lancet.
“…its whole-virion inactivated COVID-19 vaccine candidate, has proven to be safe, well-tolerated, and highly immunogenic in paediatric subjects in phase II/III study. The study has been accepted and published in Lancet Infectious Diseases, peer reviewed high impact factor journal,” said Bharat Biotech in a statement.
Covaxin is one of the two anti-Covid vaccines that have largely been used to vaccinate people under the national Covid immunisation programme. It was the first vaccine allowed for use in adolescents (15 and above) in the country.
The company conducted phase 2/3, open-label, and multicentre study to evaluate the safety, reactogenicity, and immunogenicity Covaxin in healthy children and adolescents in 2-18 years of age group.
In December last year, days after the Centre allowed use of Covaxin among 15-18 year olds, the company made public its phase 2/3 trial findings stating its vaccine was found to be “safe, well-tolerated, and immunogenic” in the age group of 2-18 years.
The firm also said that neutralizing antibodies in children, on average, were found to be 1.7 times higher than in adults.
The clinical trial was conducted in the paediatric population between June 2021 to September 2021 and showed safety, less reactogenicity, and robust immunogenicity. The data was submitted to the Central Drugs Standard Control Organisation (CDSCO) during October 2021, and received a nod for emergency use in children aged 6-18years.
For the trial, 976 subjects were screened for Sars-CoV-2 using RT-PCR and ELISA testing (enzyme-linked immunoassay), out of which, 525 eligible participants were enrolled.
“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, for primary immunization and booster doses, making Covaxin a universal vaccine. It has proven to be a highly safe vaccine based on data from more than 50 million doses administered to children in India. Vaccines are a great preventive tool; the power of vaccines can only be harnessed if used prophylactically,” said Krishna Ella, chairman and managing director, Bharat Biotech.
No serious adverse event following immunisation was also reported in the study. According to the company, a total of 374 adverse events were reported, and the majority of adverse events were mild in nature and resolved within 1 day. Pain at the injection site was the most commonly reported adverse event.
The vaccine is formulated uniquely such that the same dosage can be administered to adults and children alike, for primary and booster doses. It is a ready to use liquid vaccine, stored at 2-8°C, with 12 months shelf life and multi dose vial policy.
Whole virion inactivated vaccines have proven to be safe, tolerable with a safety track record of several decades. Several paediatric vaccines manufactured using this platform technology are being used in routine immunization programmes for primary immunization and booster doses. Several flu vaccines also utilize this manufacturing platform technology, which is safe and effective for repeated annual immunization doses and boosters.
Experts say school-going children need to be vaccinated.
As things stand, Covaxin and Biological E’s recombinant protein subunit vaccine Corbevax are both approved by the national drugs regulator for emergency use in children aged 6-12 and 5-12 respectively, the rollout is yet to take place.
“We all keep saying the disease is mild in children largely but children have become a reservoir of infection, bringing infection home and infecting family members. Also, even if so-called minor illness can be prevented then why not! The important thing is that safety and effectiveness is well-established, and long-term consequences need to be monitored. Having said that babies may not be a priority at the moment,” said Dr Rahul Nagpal, director, paediatrics department, Fortis Healthcare.
According to the company statement, Bharat Biotech has a stockpile of more than 50 million doses of the vaccine, which is ready to be distributed as required. “Bharat Biotech has established Covaxin manufacturing to reach an annualized capacity of 1 billion doses by the end of 2021.”
DIDN’T THE COMPANY VOLUNTARILY STOP OR SLOW PRODUCTION AFTER THE WHO INSPECTION? THAT IS NOW RESOLVED?
