Bharat Biotech on Tuesday issued a statement amid a delay by the World Health Organisation for emergency use authorisation for its Covid vaccine - COVAXIN. The Hyderabad based multinational biotechnology company said 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," the company added.
The emergency nod from the WHO was expected by the end of September however there is no confirmation yet from the global body.
Yesterday, according to ANI report, the UN public health agency has asked for more data from Bharat Biotech for Covaxin.
The 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.
Notably, 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 & its timelines. We are diligently working with the WHO to obtain EUL at the earliest: BharatBiotech pic.twitter.com/vuDXAp5wLq— ANI (@ANI) September 28, 2021
Earlier in an exclusive interview to ANI, Dr Bharati Pravin 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 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.
The WHO has so far approved COVID-19 vaccines by Pfizer -BioNTech, AstraZeneca, Johnson and Johnson, Moderna and Sinopharm.
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