
PAVING THE way for the rollout of the Covid-19 vaccination drive for those aged below 12 years, the Drugs Controller General of India (DCGI) on Tuesday granted emergency use authorisation to Bharat Biotech’s Covaxin for 6-12 years and Biological E’s Corbevax for 5-12 years.
The final decision will be taken by the government’s expert body on Covid-19 vaccination, health ministry sources said. Currently, India is only administering Covid-19 vaccines to those above 12 years — Corbevax for 12-14 years and Covaxin for 15-18 years.
The US Centers for Disease Control and Prevention (CDC) has recommended that all those above 5 years should be vaccinated. In the US, Pfizer’s mRNA Covid-19 vaccine is being used for children in the age group of five years and above.
According to the CDC, children in this age group (5+) are “most frequently” affected by Multisystem Inflammatory Syndrome in Children (MIS-C), a condition associated with Covid-19 where different body parts get inflamed. Noting that vaccination helps prevent MIS-C, the CDC has said that it “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 analyse and share the data.”
Breaking: 3 vaccines approved —drug regulator has granted emergency use authorisation (EUA) to Covaxin for age group 6-12 years; Corbevax has been granted EUA for the age group 5-12 years; Zydus Cadila’s two dose Covid-19 vaccine has been approved for adults @IndianExpress
— Kaunain Sheriff (@kaunain_s) April 26, 2022
On Tuesday, Bharat Biotech said according to data on Covaxin for the 2-18 years age group, neutralising antibodies in children was found to be 1.7 times higher than in adults. “Covaxin exhibits robust immune responses in children with two doses and six months follow-up, indicating durability of immune responses. Data was presented to the CDSCO Subject Expert Committee and will be published in the weeks to come,” it said.
The DCGI on Tuesday also granted emergency use authorisation to Gujarat-based Zydus Cadila’s two-dose Covid-19 vaccine for the 12 years and above population. At present, the three-dose version of ZyCoV-D is being used in the national vaccination drive for the adult population. This is the first Covid-19 vaccine built on a DNA platform, and has been approved for commercial use.
Zydus said the second dose will be administered after 28 days. It said the two-dose regimen was tested on 3,100 volunteers over 12 years of age. In its three-dose regimen, the vaccine is administered with a gap of 28 days between each jab.
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“This will increase the compliance for the vaccine and reduce the overall time required for vaccination to improve immunity against the virus. It will also help in administering the vaccine in a larger population in a shorter time, which is always desirable in the midst of a pandemic,” said Dr Sharvil Patel, Managing Director, Zydus Lifesciences.
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