The subject expert committee of the Central Drugs Standard Control Organisation (CDSCO) recommended the authorization of Serum Institute of India's (SII) Covovax for emergency use in children between the ages of 7 to 11, on Friday, 24 June.
The recommendation still needs to be approved by the Drugs Controller General of India (DCGI).
If approved, this will make Covovax the third vaccine approved for use in children under the age of 12 in India.
The first two, Biological E’s Corbevax which was approved for use in children aged 5-12 years, and Bharat Biotech's Covaxin which was cleared for use in those aged 6-12 years, were approved for emergency use in children in April 2022.
Covovax was approved for use in adults in India in December 2021.
In August 2021, 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.
So what's the status of children's COVID-19 vaccinations in India now?Which vaccines are being used and which others are in the pipeline?
When can children get the COVID-19 jab in India?
The government began inoculating children aged 12-14 in March 2022, with Biological E's Corbevax vaccine. Vaccinations for children aged 15-18 began in India in January 2022. The National Technical Advisory Group on Immunisation (NTAGI) is expected to discuss the possibilities of vaccinations for children under the age of 12.
As of May 2022, the NTAGI had not issued a recommendation for the same.
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 2021.
ZyCoV-D was 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.
Zydus Cadila began rolling out their vaccines to the government of India in February 2022.
How did Covaxin perform in kids?
The results of phase 2 and 3 clinical trials of Bharat Biotech's Covaxin trials were published in The Lancet with an efficacy rate of over 70%.
The trial was conducted in June 2021 on 528 children with 28 days apart.
What about SII's Covovax?
Covovax's approval for emergency use in adults came in December 2021. Covovax was developed by American biotechnology company Novavax. In May 2022, SII, which is producing the vaccine in India, submitted its request to the DCGI for approving emergency use of the vaccine in children under the age of 12.
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 FDA approved both Pfizer-BioNTech's and Moderna's vaccines for use in childen aged 6 months to 5 years in June 2022.
The FDA also authorised Pfizer-BioNTech COVID-19 vaccine for those aged 12 to 15 years old, in May 2021. The European Union cleared the vaccine for use among kids in May 2021.
In July 2021, 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 was started in March 2021 in the UK, but was halted in April 2021 as a precautionary measure following reports of blood clots in adults who had received the vaccine.