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Brazil Refutes Bharat Biotech Claim on EUA, Says Decision Held up Over ‘Gaps in Covaxin Data Analysis’

Empty vials of Covaxin COVID-19 vaccine lie on a table at the venue of a vaccination drive in Gauhati. (AP Photo)

Empty vials of Covaxin COVID-19 vaccine lie on a table at the venue of a vaccination drive in Gauhati. (AP Photo)

Bharat Biotech had on Wednesday said it followed a 'step-by-step' approach for the regulatory approval and supply contract of its COVID-19 vaccine in Brazil.

Just Days after Covaxin-maker Bharat Biotech came out with an a “clarification” and stated that it has received the emergency use authorisation (EUA) from Brazil, an important step for releasing a purchase order, reports have emerged that the country’ national health regulatory authority — ANVISA — had never really granted the Hyderabad-based manufacturer an EUA.

In its statement, Bharat Biotech had claimed that ANVISA “suspended the deadline for evaluating the application for emergency use of Covaxin". According to a report in NDTV, the regulatory body said “the suspension - which put the EUA application on ice - was due to missing data from the vaccine’s clinical trials.”

ANVISA clarified that it received the EUA application on June 29. On June 4 it received a notice for the import of four million Covaxin doses under “controlled conditions".

As per the The NDTV report, ANVISA said its decision on the EUA had been held up over “information gaps in the analysis of Covaxin’s data".

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India’s Bharat Biotech had on Wednesday said it followed a “step-by-step" approach for the regulatory approval and supply contract of its COVID-19 vaccine in Brazil, and that it has not received advance payments from the Brazilian health ministry.

The pharmaceutical company released the statement after Brazil’s health minister said on Tuesday the country will suspend its $324 million contract for 20 million doses of Bharat Biotech’s vaccine after whistleblowers went public with alleged irregularities in the deal.

“In the specific case of procurement of Covaxin by the Ministry of Health, Brazil, since the first meetings during Nov 2020 until June 29, a step-by-step approach has been followed towards contracts, and regulatory approvals, during this eight-month-long process," Bharat Biotech said in a statement.

“EUA received on June 4. As of June 29, Bharat Biotech has not received any advance payments nor supplied any vaccines to MOH Brazil. Bharat Biotech has followed a similar approach towards contracts, regulatory approvals and supplies in several countries worldwide, where Covaxin is being supplied successfully," said the Hyderabad-based vaccine maker.

It also said reports in the media over the past few weeks had “misrepresented" the procurement process of Covaxin in Brazil and other countries. “The procurement process for COVID-19 vaccines and several vaccines for routine immunization follow a common process which is widely accepted, and established in Industry," said Bharat Biotech.

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first published:July 05, 2021, 17:46 IST