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SEC recommends Covaxin for kids: List of jabs for children and their status reports

Covid-19 is known to usually cause mild disease in children
Last Updated : 13 October 2021, 09:47 IST

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An expert panel of India's Central drug authority on Tuesday recommended granting emergency use authorisation (EUA) to Bharat Biotech's Covaxin for children and adolescents in the 2 to 18 years age group with certain conditions.

So far, only drugmaker Zydus Cadila's DNA Covid-19 vaccine has received EUA in India to be used in adults and children aged 12 years and above. As India plans to expand its vaccination drive to include children, here is the list of Covid-19 vaccines for children and their status reports:

Zydus Cadila's ZyCoV-D:

Indigenously developed Zydus Cadila's needle-free Covid-19 vaccine ZyCoV-D has received EUA from the drug regulator, making it the first vaccine to be administered in the age group of 12-18 years in the country. The government said ZyCoV-D will be introduced in the nationwide Covid vaccination drive very shortly and would have a differential pricing than the jabs being used currently.

The vaccine has a 66 per cent efficacy and it is to be stored in a temperature range of two to eight degrees Celsius. It is to be administered intradermally in three doses at days 0, 28 and 56, using PharmaJet, an applicator that ensures painless intradermal vaccine delivery.

The Department of Biotechnology (DBT) had earlier said ZyCoV-D is the world's first DNA-based vaccine against the coronavirus and when injected into the human body, produces the spike protein of the SARS-CoV-2 virus and elicits an immune response, which plays a vital role in protection from the disease as well as viral clearance.

Biological E's Corbevax:

Hyderabad-based pharmaceutical company Biological E received the DCGI approval for conducting phase II/III human clinical trial of Covid-19 vaccine candidate Corbevax on children and adolescents aged between 5 and 18 years with certain conditions.

Corbevax, an RBD protein sub-unit vaccine, has been developed with supported from the Department of Biotechnology and its PSU Biotechnology Industry Research Assistance Council (BIRAC).

Serum Institute of India's Covovax:

Serum Institute of India (SII) is already conducting a trial of its Covid-19 vaccine Covovax, a domestically produced version of Novavax's shot, in the 12-17 age group and has presented safety data for an initial 100 participants. The DCGI in July granted permission to SII for conducting phase 2/3 trials of Covovax on children aged 2 to 17 years with certain conditions.

The Novavax vaccine is yet to be granted approval by Indian health authorities. Earlier in September, Serum Institute chief Adar Poonawalla said he expects Covovax to be approved for those below 18 years in January or February next year.

Bharat Biotech's Covaxin:

Hyderabad-based Bharat Biotech, which completed the phase 2/3 trials of Covid-19 vaccine Covaxin for use in children aged between 2 and 18 years, had submitted the data to the Central Drugs Standard Control Organisation (CDSCO) for its verification and subsequent approval for emergency use authorisation (EUA) for the jab. But Bharat Biotech has not publicly shared the efficacy and safety data for children.

If approved by India's drugs regulator, Covaxin would be the first shot to be available for kids aged between 2 and 12, while those in the 12-18 years age group can choose between Covaxin and Zydus Cadila's DNA-based vaccine.

Bharat Biotech is still in the process of securing an emergency use listing from the World Health Organization, a decision that is expected later this month. Without the WHO nod, the two-dose shot is unlikely to be accepted as a valid vaccine around the world.

Several countries have been working to authorise vaccines for children, with the United States clearing Pfizer's shot for children aged 12 and above. The advisory panel to the US regulator will meet later this month to discuss the shot for children between 5 and 11 years of age. While Covid-19 is known to usually cause mild disease in children, there is a risk of rare post-disease complications.

(With agency inputs)

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Published 13 October 2021, 05:44 IST

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