Bharat Biotech's Covaxin did not receive any approval to vaccinate children above 12 years - FACTLY
Sai Krishna Muthyanolla
May 12, 2021
A social media post is being widely shared online claiming that Covaxin, an India-made COVID-19 vaccine manufactured by Bharat Biotech has been approved for usage in children above 12 years of age. Let us fact-check the claim made in the post.
Claim: Bharat Biotech’s Covaxin received approval to vaccinate children above 12 years.
Fact: According to the Covaxin fact sheet released by Bharat Biotech, the vaccine is approved for restricted use in an emergency situation for individuals above 18 years of age. Even the Press Information Bureau has clarified that no such approval has been given by the Government of India, and that currently, only citizens above the age of 18 are eligible for COVID- 19 vaccination. Hence the claim made in the post is FALSE.
Covaxin, a COVID-19 vaccine by Bharat Biotech is developed in collaboration with the Indian Council of Medical Research (ICMR)- National Institute of Virology (NIV). Bharat Biotech had released a Fact Sheet for vaccine recipients and caregivers. According to the fact sheet, Covaxin is given approval for restricted use in an emergency situation that may prevent COVID-19. It has also been mentioned that Covaxin is approved for individuals 18 years of age and older.
The Ministry of Health and Family Welfare (MoHFW) had released Frequently Asked Questions (FAQs) document for healthcare workers and frontline workers in relation to COVID-19 vaccination in India. They have answered in the document as to why vaccination is not extended to children. As per this document, the currently available vaccines have not been evaluated in children so far, and that there are a few clinical trials now underway to test the effectiveness and safety of the COVID-19 vaccines in children. Hence, Covaxin is not authorized to be given to children yet.
When similar posts were being circulated on Twitter widely, PIB Fact Check had also mentioned that the claim was fake. No such approval has been given by the Government of India and currently, citizens above the age of 18 years are eligible for COVID-19 vaccination, says PIB Fact Check.
A tweet has claimed that Bharat Biotech's vaccine, Covaxin, has been approved for children above 12 years.#PIBFactCheck: This claim is #Fake. No such approval has been given by the Government of India. Currently, citizens above the age of 18 are eligible for #COVID19Vaccination pic.twitter.com/qdzBSfwllq
There are news articles, claiming sources, that a Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) had recommended Covaxin for Phase II/III trials on 2–18-year-olds. The articles can be seen here, here, and here. The news reports also say, ‘Earlier, the proposal to conduct trials on children was deliberated in the SEC meeting dated February 24 and Bharat Biotech was asked to submit a revised clinical trial protocol.’ But this proposal discussed in February 2021 was for 5–18-year-olds, according to the SEC recommendations dated February 24 2021 given on the CDSCO website.
However, in the United States of America, the Food and Drug Administration (FDA) expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to include adolescents 12 through 15 years of age. Earlier it was approved only for people above 16 years of age. But this has been done in USA, not in India and that too for Pfizer-BioNTech vaccine and not Covaxin.
To sum it up, Bharat Biotech’s COVID-19 vaccine, Covaxin did not receive any approval to vaccinate children above 12 years as of today.