WHO yet to authorise use of Covaxin among adolescents

Trending

On December 25, 2021, Prime Minister Narendra Modi announced that young people aged 15-17 would be eligible for the COVID-19 vaccine from January 3. Two days after the announcement, the Department of Health released guidelines for the youth immunization program.

Although it clearly states that young people 15 years of age or older (all whose age is 2007 or earlier) will be able to register for Co-WIN, the Department has emphasized that only Covaxin will be used for this age group. Covaxin was approved for emergency use for children 12 years and older on the day the Prime Minister made the announcement.

Read also: Government decision to vaccinate children COVID-19 ‘is not science’, says epidemiologist

However, the Department’s guidelines falsely state that Covaxin is “the only vaccine with a WHO (EUL) emergency list of vaccines in the 15-18 age group”.

On November 3, 2021, WHO released the Covaxin Emergency Use List (EUL) for use in adults. The November 3 press release means that the WHO Vaccine Experts Specialist Team (SAGE), which developed specific vaccine policies and recommendations for the use of vaccines in humans, on October 5 reviewed Covaxin and “recommended” the vaccine “for all ages. groups of 18 or more ”.

On November 3, the WHO again took to Twitter and announced its decision to include Covaxin in the emergency use of the COVID-19 vaccine. In a series of tweets, WHO also emphasized that SAGE reviewed and recommended “Covaxin dosage of two doses, with a dosing interval of four weeks, for all groups 18 years and older”.

A statement issued on November 24 last year reiterated that Covaxin had not yet received an emergency list for use in children. It states that although Covaxin developed by Bharat Biotech is approved in India for children aged 12-17, “it has not yet received the WHO EUL for this age mark”.
However, the Department’s guidelines falsely state that Covaxin is “the only vaccine with a WHO (EUL) emergency list of vaccines in the 15-18 age group”.

On November 3, 2021, WHO released the Covaxin Emergency Use List (EUL) for use in adults. The November 3 press release means that the WHO Vaccine Experts Specialist Team (SAGE), which developed specific vaccine policies and recommendations for the use of vaccines in humans, on October 5 reviewed Covaxin and “recommended” the vaccine “for all ages. groups of 18 or more ”.

On November 3, the WHO again took to Twitter and announced its decision to include Covaxin in the emergency use of the COVID-19 vaccine. In a series of tweets, WHO also emphasized that SAGE reviewed and recommended “Covaxin dosage of two doses, with a dosing interval of four weeks, for all groups 18 years and older”.

A statement issued on November 24 last year reiterated that Covaxin had not yet received an emergency list for use in children. It states that although Covaxin developed by Bharat Biotech is approved in India for children aged 12-17, “it has not yet received the WHO EUL for this age mark”.

Read Again: Traditional vaccines work the same way, says a U.S. scientist

In order for Covaxin to authorize children over the age of 12 to be given an emergency use list, Bharat Biotech must submit production quality, clinical and non-clinical data for children over the age of 12 and label details.

It is not yet clear how the Department of Health wrongly assumed that Covaxin has an EUL for the age group of 15-18.

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 is approved by EUL four months after application. Speaking at Times Now Summit 2021, Bharat Biotech Chairman and MD Dr. Krishna Ella said the “poor broadcast” – especially by the media – had led to delays in getting the EUL.

Editing | Child protection: COVID-19 vaccine for children and stimulant shots

But Drs. Bruce Aylward, WHO’s Senior Director-General of Adviser Tedros Adhanom Ghebreyesus, had divisions over the reasons for the delay.

“Let us be clear, the timeline for the Emergency Use Plan depends on the 99% of producers – the speed, the accuracy with which they can obtain data from the independent WHO study teams. We just want clarification on that point, ”he said.

The WHO also made it clear: “Once the information provided addresses all the questions raised, the WHO and the Technical Advisory Group will complete the assessment and come up with a final recommendation to provide an Emergency Use List.”

The WHO Emergency Use List is a requirement for the provision of vaccine through the COVAX Facility; The EUL also allows countries to expedite their legal recognition to import and regulate COVID-19 regulations.

The WHO emergency listing system is a risk-based process for testing and listing vaccines and unauthorized drugs to speed up the availability of these products to people affected by public health emergencies.

Leave a Reply

Your email address will not be published.