India Approves COVID-19 Vaccine Covaxin for Children From the Age of Two
Drug & Diagnostics Development 12/10/2021 •

The Indian government’s Subject Expert Committee (SEC) has recommended the use of the country’s home-grown COVID-19 vaccine, Covaxin, for children from the age of two.

This is the first vaccine in the world to be approved for such young children. Pfizer’s vaccine was recently approved for children from the age of 12 in the US.

India’s health ministry still has to approve the vaccine, which is the first to be  developed in India, by Bharat Biotech in collaboration with the Indian Council of Medical Research.

Covaxin has not yet been granted emergency use listing (EUL) by the World Health Organization (WHO), but a statement issued by the WHO on Monday about last week’s meeting of the Strategic Advisory Group of Experts (SAGE) on Immunization stated that SAGE had reviewed Covaxin’s application.

 “A policy recommendation will be issued when the vaccine is Emergency Use listed by WHO,” said the report, seeming to indicate that such a listing is likely.

 

India’s decision comes after Bharat Biotech presented results from a trial involving 525 children to SEC in early October. According to the company, the vaccine provided 77.8% protection against COVID-19.

Permission to test the vaccine on children was given by India’s drugs controller general, Dr VG Somani, following trials on adults.

However, final results have yet to be published in a peer-reviewed journal and the Indian government approved Covaxin before its phase 3 trial was completed. However, phase 1 results published in the Lancet established that the vaccine is safe. 

According to the BMJ, Covaxin “is similar to CoronaVac (the Chinese vaccine developed by Sinovac) in that it uses a complete infective SARS-CoV-2 viral particle consisting of RNA surrounded by a protein shell, but modified so that it cannot replicate”.

Covaxin can be stored in a normal fridge at 2-8°C, and people need to get two doses around 20 days apart.

Each dose of Covaxin costs 295 rupees (around $4) versus $25-$38 for the Moderna vaccine and $36,30 for the Pfizer/BioNTech, according to the BMJ. This makes the Indian vaccine the cheapest purchased by any country in the world.

Covaxin is already being used in 21 states according to Suchitra Ella, co-founder of Bharat.

Meanwhile, the US Food and Drug Administration (FDA) is meeting later this month to discuss a request from Pfizer to review data for COVID-19 vaccination for children aged 5 to 11 years and consider emergency authorisation of the vaccine for this age group. ​​

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