Bharat Biotech confirms submission of docs for emergency use list of Covaxin

Bharat Biotech to conduct Phase-4 trial to check the efficacy of Covaxin
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Bharat Biotech International Limited (BBIL) confirmed the submission of documents required for the emergency use list of Covaxin.

The officials at BBIL informed the Government on Monday about the submission. Moreover, the organization also assures of attaining approval by the World Health Organization.

Meanwhile, the WHO has stated that the submission made by the firms worldwide will remain confidential under the “emergency use procedure”.

The results gained from the assessment if found suitable will be released officially by WHO.

However, a recent report guideline released by WHO reveals that Bharat Biotech submitted their Expression of Interest (EOI) and more information is still expected.

Also, a pre- submission meeting is proposed in May-June 2021 as per the guidance document.

What lies ahead for Bharat Biotech?

As per the agency, the duration for assessing the emergency use listing is on the data quality submitted by the vaccine manufacturer. In addition to the quality of data, the time scale also depends on the criteria ascertained by WHO.

The approval by WHO can be considered as an essential as discussion regarding granting vaccine passports is being carried out. The vaccine passports are highly considered to be granted to only those that are WHO approved.

The MEA, Health ministry and Department of Biotech conducted a meeting with BBIL MD Dr. V Krishna Mohan and his colleagues, reports The Indian Express. The meeting focused on the application status for WHO’s emergency use listing on Covaxin.

The acceptance of Covaxin in almost 11 countries was called out during the meeting. As per a source, “ BBIL is confident about obtaining WHO EUL subsequently, given its experience of getting its other vaccines prequalified by WHO,”
Covaxin is India’s first indigenous Covid vaccine, developed by the corona vaccine manufacturer BBIL.

The efficacy of the vaccine is stated to be average as the count falls between 70- 90 per cent. Meanwhile, in the Phase 3 of clinical trial on Covaxin shows an interim vaccine efficacy of 81 per cent against the novel coronavirus.

BBIL is in the last stage of submitting the final documents for Covaxin approvals in Brazil and Hungary. Moreover, the authorities in the above country and BBIL are in regular contact.

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