WHO Yet to Grant EUL to Covaxin for Teens

Manas Dasgupta

NEW DELHI, Jan 6: Even though India has launched vaccination for the teen-agers on January 3 and lakhs of young ones have taken the jabs, experts have pointed out that “Covaxin” is yet to get a nod from the World Health Organisation (WHO) for emergency use listing (EUL) for people below 18 years age.

On December 25, in a national telecast, the prime minister Narendra Modi had announced launch of vaccination for the people in the 15-18 age group and a few days later the union health ministry while setting the guidelines for the teen vaccination programme confirmed that only “Covaxin” would be administered to the young ones in the 15-18 age group. It justified the decision claiming that “Covaxin” had been approved by the WHO for emergency use in children.

In fact, “Covaxin” manufactured by the Hyderabad-based Bharat Biotech had received emergency use approval from the Indian Council of Medical research (ICMR) the same day the prime minister in a late evening telecast announced the vaccination programme for the teen-agers along with booster doses for the senior citizens and frontline workers due to begin from January 10. However, the Ministry guidelines wrongly stated that Covaxin is the “only vaccine with WHO’s emergency use listing (EUL) for the age-group 15-18.” At several occasions, the WHO had insisted that “Covaxin” had been approved for emergency use for “all age group above 18 years.”

On November 3, 2021, the WHO had issued an emergency use listing (EUL) for Covaxin for use in adults. The press release of November 3 says that WHO’s Strategic Advisory Group of Experts on Immunization (SAGE), which formulates vaccine specific policies and recommendations for vaccines’ use in populations, had on October 5 reviewed Covaxin and “recommended” the vaccine in “all age groups 18 and above.”

On November 3, WHO also took to Twitter to broadcast its decision to include Covaxin in the emergency use listing of COVID-19 vaccines. In a series of tweets, the WHO reiterated that the SAGE had reviewed and recommended the “use of Covaxin in two doses, with a dose interval of four weeks, in all age groups 18 and above”.

A statement issued on November 24, 2021, once again stresses that Covaxin has not received emergency use listing for use in children. It states that though Covaxin developed by Bharat Biotech has been approved in India for children 12-17 years, it has “not yet received WHO EUL for this age indication”.

For Covaxin to be approved for children above 12 years to be granted an emergency use listing, Bharat Biotech has to submit manufacturing quality data, clinical and non-clinical data of the vaccine in children above 12 years and labelling details. The manufacturer, however, has not yet submitted the necessary details to the WHO for approval.

It is not clear how the Health Ministry had incorrectly said Covaxin has an EUL for the 15-18 years age group. Bharat Biotech began the process of seeking WHO’s EUL for Covaxin for use in adults when it submitted its application on July 9. Bharat Biotech was repeatedly asked by the WHO to clarify and submit additional data. The vaccine was approved for EUL four months after the application was submitted. Though Bharat Biotech Chairman and MD Dr. Krishna Ella had told a section of the media that “negative publicity” — particularly by the media — led to delay in getting the EUL, Dr. Bruce Aylward, Senior Advisor to WHO Director General Tedros Adhanom Ghebreyesus, was categorical on the reasons for the delay.

“Let’s be very clear, the timeline for Emergency Use Listing a vaccine depends 99% on manufacturers — the speed, the completeness with which they can get data to the independent groups that assesses for WHO. We just want to be very, very clear on that point,” he said.

The WHO also made it clear saying: “When the information provided addresses all questions raised, WHO and the Technical Advisory Group will complete the assessment and come to a final recommendation whether to grant Emergency Use Listing to the vaccine.”

The WHO’s emergency use listing is a prerequisite for vaccine supply through the COVAX Facility; the EUL also allows countries to expedite their own regulatory approval to import and administer COVID-19 vaccines. The WHO’s emergency use listing procedure is a risk-based procedure for assessing and listing unlicensed vaccines and drugs to expedite the availability of these products to people affected by a public health emergency.