Updated: April 27, 2022 10:50:57 am
The national drug regulator has granted emergency use authorisation (EUA) to Bharat Biotech’s Covaxin for the age group 6-12, and to Biological E’s Corbevax for the age group 5-12. This paves the way for the rollout of Covid-19 vaccination for children aged 12 and under.
Why have the approvals come now?
India has been rolling out Covid-19 vaccines in a phased manner based on scientific and epidemiological evidence. In the first phase, it prioritised groups at the highest risk: healthcare and frontline workers, and the elderly. It expanded the drive, in phases, to cover all adults. As scientific knowledge evolved and more vaccines became available, the government introduced vaccination for the 15-18 age group in January this year, and for the 12-14 age group in March.
The EUAs for children up to age 12, granted by the regulator Drugs Controller General of India, have come on the basis of data from trials submitted by the vaccine manufacturers. With Tuesday’s decision, India is a step away from rolling out vaccination for this age group.
So, when will children of this age group get vaccinated?
The regulatory approval and data on the vaccines will be placed before three government expert bodies. These include the National Technical Advisory Group on Immunisation (NTAGI), which provides guidance to the government on vaccination by undertaking technical reviews of scientific evidence, and the COVID-19 Working Group and Standing Technical Sub-Committee. Next, the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) will make a final recommendation to the Health Ministry. The final decision is expected to come within a few days.
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Why is rolling out vaccines for young children an important step?
Covid-19 vaccines protect against severe disease, death, and hospitalisation. Hence, as children have returned to school, vaccination will play a key role in protecting them.
In the United States, the Centers for Disease Control and Prevention (CDC) recommends that everyone aged 5 years and older should get vaccinated against Covid-19. In the US, Pfizer/BioNtech’s mRNA vaccine is being used for this age group.
The CDC notes that children aged 5-12 are “most frequently” affected by multisystem inflammatory syndrome in children (MIS-C), a condition associated with Covid-19 and marked by inflammation of various parts of the body. “CDC is collecting data on how well COVID-19 vaccination works against MIS-C in younger children. As more children under 12 years old get vaccinated, CDC will be able to analyze and share those data,” the CDC says.
Will there be a choice of vaccines?
The final decision on which vaccine will be available for this age group in India will be recommended by the government. For instance, the government allows only Corbevax to be administered to those in the 12-14 age group, and only Covaxin to those in the 15-18 age group. The Zydus Cadila DNA vaccine, which has been approved for children aged 12 and above, has not been used in the vaccination drive so far.
What is the efficacy and safety profile of these vaccines?
On Tuesday, Bharat Biotech, which is conducting one of the world’s first Covid-19 vaccine trials to generate data in the 2-18 year age group, said neutralising antibodies in these children were 1.7 times higher than in adults. “Covaxin exhibits robust immune responses in children with 2 doses and 6 months follow up, indicating durability of immune responses. Data was presented to the CDSCO (Central Drugs Standard Control Organisation) Subject Expert Committee and will be published in the weeks to come,” Bharat Biotech said.
Last September, Biological E received approval to conduct phase 2/3 trials with Corbevax in children and adolescents aged 5-18. After getting a no-objection certificate, the company initiated the study in October 2021 (which is ongoing), and has evaluated safety and immunogenicity results. The company said the data indicates that the vaccine is safe and immunogenic.
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