The emergency use authorisation (EUA) for Bharat Biotech's COVID-19 vaccine Covaxin has once again been delayed by the World Health Organisation, said sources.
The sources further said that the UN public health agency has asked for more data from Bharat Biotech for Covaxin.
This delay will affect Indians especially students and who have international travel plans. 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.
"As a responsible manufacturer with past approvals for our other vaccines, we do not find it appropriate to speculate or comment on the regulatory approval process and its timelines. We are diligently working with the WHO to obtain EUL at the earliest," said Bharat Biotech in a statement.
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."
Dr V K 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.
The WHO has approved COVID-19 vaccines by Pfizer -BioNTech, AstraZeneca, Johnson and Johnson, Moderna and Sinopharm.
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