New Delhi: With India’s Covid vaccination drive for 15-18-year-olds being rolled out from Monday, Covaxin — the sole vaccine available for this age group — has only received World Health Organization (WHO) approval for use in adults, and not for those aged between 12 and 18, contrary to the health ministry’s claims.
In the revised vaccination guidelines posted on the Ministry of Health and Family Welfare’s website on 27 December, Covaxin, the Covid vaccine developed by Hyderabad-based Bharat Biotech and the Indian Council of Medical Research (ICMR), is described as “the only vaccine with EUL for the age group 15-18″.
EUL stands for ‘Emergency Use Listing’, which is the WHO’s risk-based procedure for assessing and listing unlicensed vaccines, therapeutics and in vitro diagnostics.
However, the WHO in a statement released in November had noted that although Covaxin was approved in India for those aged 12-17 years, it has not yet received WHO EUL for this age indication.
On Friday, the health ministry issued a clarification saying the EUL by the national regulator, CDSCO, for the 12-18 age group was accorded on 24 December.
The guidelines issued by the Union Ministry of Health at no place mention about EUL by WHO, it said.
“The EUL by CDSCO, the national regulator, for Covaxin vaccine for age group 12-18 age group was accorded on 24 December. Subsequently, the guidelines for vaccination of 15-18 yr age group of young adults and precaution dose for other identified categories was issued by it on 27 December,” the health ministry added.
ThePrint reached the health ministry, and the communication team of the WHO for comment via email Monday morning, but is yet to receive a response. A Bharat Biotech spokesperson said via text that the data for vaccine, vis-a-vis minors, will now be submitted to other regulators such as WHO and to other countries.
Although the trial results among minors for Covaxin are yet to be published in a peer-reviewed journal, Bharat Biotech has uploaded the results of the clinical trial on a preprint repository. The study said the antibody response in children was 1.7 times higher than that seen in adults.
The Drugs Controller General of India (DCGI) has approved two Covid vaccines so far for use in people under the age of 18. However, only Covaxin is currently being deployed in the vaccination drive for the 15-18 age group.
In August last year, Zydus Cadilla’s ZyCoV-D — the world’s first DNA vaccine — was also given DCGI approval for use in those above the age of 12, but has not yet been included in India’s vaccination programme.
Covaxin received DCGI approval for the 12-18 age group on 25 December. Prime Minister Narendra Modi announced the same day that vaccination for the 15-18 age group would begin from 3 January.
The process for Emergency Use Listing
Through the evaluation of submitted data, the WHO determines whether a vaccine’s quality, safety and effectiveness are acceptable, and if the benefits outweigh the foreseeable risks and uncertainties of a pandemic.
To apply for an EUL, the vaccine manufacturer must submit manufacturing quality data, non-clinical and clinical data, and labelling details.
The manufacturer must also submit a plan to monitor quality, safety and efficacy in the field and an undertaking to submit any new data to the WHO as soon as it becomes available.
Covaxin was rolled out in India for use in adults long before it received WHO approval. While it was deployed alongside Covishield as vaccination for healthcare workers began in January last year, and for the entire adult population in May, the WHO approval for Covaxin was received only in November.
This EUL was for use in adults.
Although the vaccine formulation is the same for adults as it is for children, the safety and efficacy data will need to be submitted separately for this group.
(Edited by Rohan Manoj)
The report has been updated to add the health ministry’s statement issued Friday.