Covaxin, Zydus Cadila: What Vaccines are in the Pipeline for Children in India
The Centre had earlier said it plans to begin Covid vaccination in kids aged 12-17, with comorbidities, by October.
The subject expert committee of the Drugs Controller General of India (DCGI) has recommended emergency use approval for Covaxin for children between ages 2-18 for emergency use. The final nod will come from the DCGI.
If approved, this will make Covaxin the second vaccine to be approved for children in India, and the first in the world to be approved for children below the ages of 12.
Pfizer and BioNTech's vaccine for under 12s is yet to be approved by the US Food and Drug Administration (FDA). The Pfizer vaccine though is not available in India.
In August, the DCGI had given Gujarat-based pharmaceutical company Zydus Cadila’s three-dose COVID-19 vaccine emergency use authorisation for use in both adults as well as children above the age of 12 years.
In India, the latest sero survey suggests that about 60 percent of children have been exposed to the virus since the pandemic.
Despite approval, Zydus Cadila's vaccines are yet to roll out and Covaxin's Bharat Biotech is not in a position to meet the demands of vaccinating children in India.
So when can children get the COVID jab? Which are the vaccines in the pipeline?
When can children get the COVID jab in India?
The government had said that it plans to begin COVID vaccination in children in the 12-17 age group, to those who have comorbidities by October.
There is no more information on when that roll out will begin.
Which COVID vaccines may be available for children in India in the future?
Zydus Cadila's ZyCoV-D
Bharat Biotech's Covaxin
Serum Institute of India's Covovax
Johnson & Johnson
Biological E's Corbevax
What's the status of Zydus Cadila's COVID vaccine?
Gujarat-based Zydus Cadila’s three-dose COVID-19 vaccine was granted emergency use authorisation for use in adults and children above 12 years by the country's drug regulator in August, making it potentially the first vaccine to be administered to the adolescent group in India.
ZyCoV-D is the world's first COVID-19 vaccine built on a DNA platform to be granted emergency use authorisation.
It's a needle-free vaccine, which needs to be given in three separate doses.
The company has said it hopes to start trials in younger children aged two and over, soon, according to BBC.
This is currently little information on when these vaccines will be rolled out.
How did Covaxin perform in kids?
The data from Phase 2-3 clinical trials of the vaccine being developed by Indigenous vaccine maker Bharat Biotech was submitted to the DCGI in August. This data is not publicly available yet.
The DCGI had given a nod to the company to conduct Phase 2 and 3 clinical trials in May this year. The trial was conducted in June on 528 children with 28 days apart.
What about SII's Covovax?
The KEM Hospital and Research Centre at the Vadhu Bukruk village in Pune district has begun enrolling children for phase 2-3 clinical trials of Serum Institute of India's coronavirus vaccine Covovax for those aged 2-17 years, The Indian Express reported.
Covovax has been developed by American biotechnology company Novavax. SII, which is producing the vaccine, will conduct the trials in India.
The company will conduct trials on children aged 2 to 17 years and the trial will cover about 920 children in two age groups across 10 test sites.
The trials for the first group will be conducted for those between 2 and 11 years and the second between 12 and 17 years.
What's the status of J&J and Corbevax?
Johnson & Johnson has applied for permission to conduct COVID-19 vaccine trials for kids in the age group of 12 years to 17 years in India.
The company has already received EUA, or emergency use approval, for its single-dose vaccine, which will be supplied via an agreement with Hyderabad-based Biological E. Limited.
The vaccine has 66 percent efficacy in preventing moderate to severe illness due to COVID and 85 percent efficacy against severe cases.
Biological E may also launch its vaccine, Corbevax, in October with phase 3 trial underway, according to reports
Earlier this month, the DGCI gave permission to Biological E to conduct phase 2-3 clinical trials of Corbevax on children between five-18 years with certain conditions.
Which are the other vaccines approved for children internationally?
The US Food and Drug Administration (FDA) has authorised Pfizer-BioNTech COVID-19 vaccine for those aged 12 to 15 years old, in May. The European Union also cleared the vaccine for use among kids in May.
The company has applied for FDA approval for use of its COVID vaccine in children aged 5 years and older.
In July, the European medicines watchdog approved the use of Moderna's mRNA COVID-19 vaccine for children aged 12 to 17.
The EU drug regulator said the Spikevax vaccine was found safe for children aged 12 to 17 years and produced a comparable antibody response as seen in young adults aged 18 to 25 years.
For both Pfizer and Moderna, legal hurdles need to be sorted out for its vaccines to be available in India.
What about Covishield? Are vaccine trials for kids happening with the AstraZeneca vaccine?
A trial for AstraZeneca's COVID-19 vaccine in children between the ages of 6-17 did start in March 2021 in the UK, but was halted as a precautionary measure following reports of blood clots in adults who had received the vaccine.
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