Bharat Biotech’s Covaxin is soon to be included in the list of Emergency Use Authorization (EUA) of the World Health Organization (WHO).
As per the latest, ‘Status of COVID-19 vaccines within WHO EUL/PQ evaluation process’ document dated September 29, Thursday on the WHO website, the decision for Bharat Biotech’s Covaxin shall be decided by October 2021. To take a final call on EUA to Covaxin, WHO’s Strategic Advisory Group of Expert on Immunization (SAGE) is set to meet on October 5.
Details
Currently, the two widely used vaccines in India for COVID-19 include Bharat Biotech’s Covaxin and AstraZeneca and Oxford University’s Covishield.
Covaxin has been developed by a Hyderabad-based vaccine manufacturer, Bharat Biotech with a partnership of the National Institute of Virology and the Indian Council of Medical Research. In the Bharat Biotech Phase 3 trial results, the vaccine showed an efficiency of 77.8 percent.
Bharat Biotech had submitted all the necessary documents required for EUL of Covaxin in July 2021 to the global health agency, WHO.
As per the statement of WHO, it began rolling data on the Covaxin on the 6th of July 2021 to start its review right away. While rolling data, information continues to come in, to accelerate the overall review process. The World Health Organization (WHO) has already approved COVID-19 vaccines by Pfizer -BioNTech, AstraZeneca, Johnson and Johnson, Moderna, and Sinopharm.
Also Read: Manipur Teen Makes Iron Man Suit from Scrap, Anand Mahindra Steps in as Tony Stark
Importance of Emergency Use Authorization (EUA) by WHO
As per the World Health Organization’s (WHO) guidelines, EUA is a procedure that involves streamlining the process in which new products can be approved for use during public health emergencies like in a pandemic.
As per WHO, the submissions made to it for listing or prequalification under the EUA are confidential and will be published by WHO only if the product submitted for assessment meets the criteria of listing. The duration of the EUA listing process depends on the quality of the data submitted by the vaccine manufacturer and whether it is meeting the WHO criteria.
Obtaining Emergency Use Authorization (EUA) from WHO is important, as most of the countries around the world would not accept Covaxin without it.
What Bharat Biotech has to say
Bharat Biotech, the Covaxin manufacturer said that they have submitted all data about Covaxin to the WHO for EUA approval and are awaiting feedback from the global health watchdog. Further, they said that they are ‘working diligently with the WHO to obtain EUL at the earliest.’
Bharat Biotech also reacted to a reporting made earlier commenting that WHO had delayed the EUA for Covaxin due to some technical queries. Bharat Biotech in its statement said that it is not appropriate for anyone to speculate or comment on the regulatory approval process and time. In its statement, it mentioned that all the relevant trial data has been submitted to WHO and all the clarifications by the UN health agency have been made.
In its statement, it said, “We have responded to any clarifications sought by WHO and are awaiting further feedback. As a responsible manufacturer with several prequalified vaccines, we do not find it appropriate to speculate or comment on the approval process and its timelines.”
