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Actively working with WHO, emergency use authorisation for Covaxin expected soon: Bharat Biotech
The emergency use authorisation (EUA) is important because without it Covaxin will not be accepted by most countries.
Highlights
- All the relevant trial data has been submitted to WHO
- This delay will affect Indians especially students and who have international travel plans
New Delhi: The emergency use authorisation (EUA) for Bharat Biotech`s COVID-19 vaccine Covaxin has once again been delayed by the World Health Organisation. But the Bharat Biotech has said that it is 'working diligently with the WHO to obtain EUL at the earliest.'
The EUA is important because without it Covaxin will not be accepted by most countries. The Strategic Advisory Group of Expert on Immunization (SAGE) will be meeting on October 5 on EUA to Covaxin.
Earlier in an exclusive interview to ANI Dr Pravin Bharati Pawar, Minister of State for Union Ministry of Health and Family Welfare said, "There is the procedure of submitting the documents for approval. WHO`s emergency use authorisation is expected soon."
In an statement, the company has that it is not appropriate to speculate or comment on the regulatory approval process and at appropriate time it will announce about the regulatory approval.
Dr VK Paul, Member (Health), Niti Aayog also indicated in a press briefing that the WHO EUA is expected in the last week of September. According to Bharat Biotech Phase 3 clinical trials of Covaxin demonstrated an efficacy rate of 77.8 per cent.
All the relevant trial data has been submitted to WHO, and all clarifications by the UN health agency have been responded to Bharat Biotech.
"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," the Hyderabad-based company said in a statement.
This delay will affect Indians especially students and who have international travel plans. The WHO has approved COVID-19 vaccines by Pfizer -BioNTech, AstraZeneca, Johnson and Johnson, Moderna and Sinopharm.
(With Agency inputs)