Covaxin Has Not Got WHO Nod for Children, Unlike Health Ministry's Claim
Covaxin has neither been granted WHO's Emergency Use Listing for children, nor is it the only vaccine to get DCGI nod for adolescents
India saw the next phase of its vaccination drive commence on January 13, 2021 for adolescents in the age group of 15-18 years. But, the Union Ministry of Health & Family Welfare, in the vaccination guidelines issued on December 27, 2021, claimed that Covaxin is the only vaccine for this age group in India to have been granted Emergency Use Listing, which is World Health Organization's risk-based procedure for assessing and listing unlicensed vaccines.
The MoHFW, in the guidelines, mentioned that in this phase the vaccination option will only be Bharat Biotech's Covaxin as it "is the only vaccine with EUL for the age group 15-18". There are two errors in this statement:
1. WHO hasn't issued EUL for Covaxin for the age group of 15-18 years
2. Covaxin got Emergency Use Authorization (EUA) from Drug Controller General of India (DCGI), but it's not the only one to have received this.
Covaxin Got No WHO Approval for Children
The WHO's Strategic Advisory Group of Experts on Immunization (SAGE) recommended, in October 2021, that Covaxin be issued EUL as "clinical trial data demonstrated an efficacy rate against symptomatic COVID-19 of 78%".
A month later, on November 3, 2021, Covaxin became the eighth vaccine in the world to be issued EUL by the WHO. This approval was granted for use of the vaccine in two doses, with a dose interval of four weeks, for people aged 18 years and above.
In fact, in a statement on November 29, 2021, the WHO clarified that Covaxin has not received WHO's approval for the 12-17 age group. "Covaxin, an adjuvanted inactivated vaccine developed by Bharat, was approved in India for the age indication of 12-17 years; but not yet received WHO EUL for this age indication," read the statement.
Covaxin Not First or Only Vaccine to Get DGCI Nod
While Covaxin received DCGI's Emergency Use Authorization (EUA) for age group 12-18 years on December 24, 2021, Zydus Cadila got it too for its DNA based vaccine ZyCoV-D for people aged 12 years and above about four months before that on August 20, 2021.
Even WHO, in its November statement, mentioned how ZyCoV-D has been approved by DCGI but not WHO. "The Indian regulatory authorities have given approval to ZycovD, a novel DNA vaccine, for ages 12-17 years; however, this vaccine has not yet received WHO EUL," stated WHO. But, ZyCoV-D has not been included in India's vaccination drive till now.
FactChecker tried contacting Dr. Manisha Verma, Additional Director General (Media & Communications), MoHFW via call and email but had not heard from her by the time of publishing. We also contacted Bharat Biotech's spokesperson, who said they'd have to check and get back to us. As and when we receive a response from either of them, it'll be updated here.
