The national drug regulator has given Bharat Biotech’s Covaxin and Biological E’s Corbevax emergency use authorization (EUA) for the age groups 6-12 and 5-12, respectively. This clears the way for the Covid-19 immunisation to be rolled out to children aged 12 and younger.
Covid-19 vaccinations have been being out in India in phases based on scientific and epidemiological evidence. In the initial phase, it focused on the most vulnerable populations, such as healthcare and frontline workers, as well as the elderly. It gradually broadened the drive to include all adults. The government began immunisation for the 15-18 age range in January of this year, then for the 12-14 age group in March, as scientific understanding advanced and new vaccinations became accessible.
The EUAs for children under the age of 12 were given by India’s drug regulator, the Drugs Controller General, based on data from vaccination studies supplied by the makers. India is one step closer to implementing immunisation for this age range after Tuesday’s decision.
Three government expert organisations will review the regulatory approval and data on the vaccinations. The National Technical Advisory Group on Immunization (NTAGI), which conducts technical evaluations of scientific data to advise the government on vaccination, and the COVID-19 Working Group and Standing Technical Sub-Committee are two examples. The National Expert Group on COVID-19 Vaccine Administration (NEGVAC) will next provide a final recommendation to the Ministry of Health. The final decision should be made within the next several days.
Vaccines against Covid-19 protect against serious illness, death, and hospitalisation. As a result, vaccination will play a critical role in protecting children now that they have returned to school.
The Centers for Disease Control and Prevention (CDC) in the United States advises that everyone aged 5 and above receive vaccinated against Covid-19. For this age range, Pfizer/mRNA BioNtech’s vaccination is utilised in the United States.
Children aged 5 to 12 are “most commonly” impacted by multisystem inflammatory syndrome in children (MIS-C), a disorder linked to Covid-19 and characterised by inflammation in numerous body organs, according to the CDC. “The CDC is gathering information on how effective COVID-19 vaccine is against MIS-C in young children. The CDC will be able to study and exchange data as more children under the age of 12 get vaccinated, according to the CDC.
The government will make the ultimate choice on which vaccination would be accessible for this age range in India. For example, the government authorises only Corbevax to be administered to children aged 12 to 14, and only Covaxin to children aged 15 to 18. So far, the Zydus Cadila DNA vaccine, which is licenced for children aged 12 and up, has not been utilised in the immunisation campaign.
Bharat Biotech, which is undertaking one of the world’s first Covid-19 vaccination studies in children aged 2 to 18, said on Tuesday that neutralising antibodies were 1.7 times greater in young children than in adults. “Covaxin produces substantial immune responses in children after two doses and a six-month follow-up, demonstrating that immunological responses are long-lasting.” The data was provided to the CDSCO Subject Expert Committee and will be published in the next weeks, according to Bharat Biotech.
Biological E got clearance in September to undertake phase 2/3 Corbevax studies in children and adolescents aged 5 to 18. The business began the trial in October 2021 (which is still ongoing) after receiving a no-objection certificate, and has analysed safety and immunogenicity outcomes. The research demonstrates that the vaccination is both safe and immunogenic, according to the business.