On January 3, India saw the next phase of its vaccination drive commence for those in the age group of 15 years to 18 years. The Union Ministry of Health and 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 ministry, 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 emergency use listing for the age group 15-18”. There are two errors in this statement:
- WHO has not issued emergency use listing for Covaxin for the age group of 15-18 years
- While Covaxin got emergency use authorisation from the Drug Controller General of India, it is not the only one to have received this.
The World Health Organization’s Strategic Advisory Group of Experts on Immunization recommended, in October 2021, that Covaxin be issued emergency use listing 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 emergency use listing 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 World Health Organization clarified that Covaxin has not received its 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 [emergency use listing] for this age indication,” read the statement.
Emergency use authorisation
While Covaxin received Drug Controller General of India’s Emergency Use Authorization for age group 12 years-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 World Health Organization, in its November statement, mentioned how ZyCoV-D has been approved by the Drug Controller General of India 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 [emergency use listing],” 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), Ministry of Health and Family Welfare 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 would have to check and get back to us. As and when we receive a response from either of them, it will be updated here.
This article first appeared on FactChecker.in, a publication of the data-driven and public-interest journalism non-profit IndiaSpend.