Does Covaxin have WHO’s approval for use in children?

The health ministry’s guidelines says Covaxin is the “only vaccine with WHO’s Emergency Use Listing (EUL) for the age-group 15-18”. This is incorrect. WHO has granted Emergency Use Listing for Covaxin for use in adults 18 years and above only.

On December 25, 2021 Prime Minister Narendra Modi announced that adolescents aged 15-17 years will be eligible for a COVID-19 vaccine beginning January 3, and a “precaution dose” will be provided to health-care and frontline workers and those above 60 years with comorbidities from January 10. Two days after the announcement, the health ministry issued guidelines for the vaccination programme for teenagers and precaution dose for the three high-risk groups.

While clearly stating that teenagers aged 15 years or more (all those whose birth year is 2007 or before) will be able to register on Co-WIN, it emphasises that only Covaxin will be administered to this age group. Covaxin was granted an emergency use approval for use in children 12 years and above on the same day the Prime Minister made the announcement.

The guidelines do not state that Covaxin is the only COVID-19 vaccine permitted for use in children above 12 years. (Zydus Cadila’s vaccine ZyCoV-D was granted an EUA by the regulator on August 21, 2021 for children above 12 years but the government decided to restrict its use to adults on November 14.)

But the guidelines state: “Covaxin as this is the only vaccine with EUL for the age-group 15-18.” Emergency Use Listing or EUL is granted only by WHO to allow international bodies such UNICEF to procure drugs/vaccines with EUL for supply to other countries. India uses the term emergency use approval/authorisation or restricted use approval but never EUL.

On November 3, 2021 WHO issued an emergency use listing (EUL) for Covaxin only for 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 announced granting emergency use listing to Covaxin and reiterated that 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 last year 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 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.

Bharat Biotech began the process of getting Covaxin for adults an emergency use listing when it submitted its application on July 9. “All documents required for Emergency Use Listing (EUL) of Covaxin have been submitted to WHO as of July 9. The review process has now commenced with the expectation that we will receive EUL from WHO at the earliest.” Dr Krishna Ella, chairman and managing director of Bharat Biotech said in a statement posted on Twitter on July 12.

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. At the Times Now Summit 2021, Dr. Ella said deflected blame when he said “negative publicity”, particularly by the media, led to delay in getting the EUL.

But Dr. Bruce Aylward, Senior Advisor to WHO Director General Dr Tedros Adhanom Ghebreyesus pointed out where the delay came from. “Let’s be very clear, the timeline for EULing 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

WHO repeated a similar message on Twitter: “The timeframe for the WHO Emergency Use Listing procedure is dependent on how quickly a company producing the vaccine is able to provide the data required for WHO to evaluate the vaccine’s quality, safety, efficacy and its suitability for low- and middle-income countries.” 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.”

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 expediate the availability of these products to people affected by a public health emergency.

Published in The Hindu on January 6, 2022