Bharat Biotech on Friday said it has submitted all data related to its covid-19 vaccine vaccine to the World Health Organization (WHO) for emergency use list (EUL) and is now awaiting feedback from the global health organization. The WHO is currently reviewing data from Bharat Biotech and the date for the decision on the vaccine “is yet to be confirmed”, according to the latest information available on the WHO website.
The WHO is currently reviewing data from Bharat Biotech and the date for the decision on the vaccine “is yet to be confirmed”, according to the latest information available on the WHO website.
Indian multinational biotechnology company Bharat Biotech on Friday said it has submitted all data related to its COVID-19 vaccine Covaxin to the WHO for emergency use list and is awaiting a response from the global health watchdog. Sharing the post on its Twitter handle, Bharat Biotech noted: “Covaxin clinical trial data was fully compiled and available in June 2021. All data for Emergency Use List (EUL) application to the World Health Organization in early July.” Submissions were made. We have responded to any clarifications sought by #WHO and awaits further response.”
As a trusted manufacturer with no previous approvals for its other vaccines, the company said it would not be appropriate to speculate or comment on the approval process and its timeline, it added. The vaccine maker said in multiple tweets, “We are continuing to work diligently to achieve WHO’s emergency ice listing process as quickly as possible.
Bharat Biotech tweeted, “Covacine clinical trial data was fully compiled and available in June 2021. All data for the Emergency Use List (EUL) application was submitted to the World Health Organization in early July. We have responded to the clarification sought by WHO and are awaiting further feedback.” The company further said that as a responsible manufacturer it would not be appropriate to speculate or comment on the approval process and its timeline.
Bharat Biotech said that the company is trying diligently to get the WHO EUL at the earliest. The WHO said on its website that it is reviewing the vaccine data.
The regulatory body of western countries has not given approval,
let us tell you that at present emergency use of Bharat Biotech vaccine is allowed in India, but till now this vaccine has not been approved by the regulatory body of any western country. Because of this, many countries have not allowed the travel of people who have got the vaccine.
According to a study recently published by the Indian Council of Medical Research (ICMR) in BioRxiv, Bharat Biotech’s covid-19 vaccine is effective against the delta plus form of Covaxin corona. The study states that IgG antibodies have been evaluated. In this, the possibility of covid-19 has been eliminated in individuals receiving the full dose of BBV 152 vaccine. It evaluated BBV152 vaccines against Delta, Delta AY.1 and B.1.617.3.
In an update on its website, the WHO said it began rolling out data for the vaccine on 6 July. Rolling data allows WHO to begin its review immediately, as information continues to come in to accelerate the overall review process. Union Health Minister Mansukh Mandaviya had earlier also met WHO Chief Scientist Dr Soumya Swaminathan and discussed the approval of Bharat Biotech’s COVID-19 vaccine Covaxin