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India made Covid vaccine Covaxin's wait for the WHO nod just got longer.
The World Health Organisation's technical advisory group on Tuesday sought "additional clarifications" from Covaxin maker Bharat Biotech to conduct a final "risk-benefit assessment" for Emergency Use Listing of the vaccine.
The technical advisory group will now meet on November 3 for a final assessment.
Hyderabad-based Bharat Biotech had submitted Expression of Interest to the WHO on April 19 for the vaccine's Emergency Use Listing.
"The TAG met on October 26 and decided that additional clarifications from the manufacturer are needed to conduct a final EUL risk-benefit assessment for global use of the vaccine," the WHO said in an email response to a question by PTI on the decision regarding the Emergency Use Listing of Covaxin.
"The TAG expects to receive these clarifications from the manufacturer by the end of this week, and aims to reconvene for the final risk-benefit assessment on Wednesday, 3 November," it added.
The Covaxin has demonstrated 77.8 per cent effectiveness against symptomatic Covid-19 and 65.2 per cent protection against the new Delta variant. In June, the company said it concluded the final analysis of Covaxin efficacy from Phase 3 trials.

Nod to Covaxin delayed further as WHO has more questions for Bharat Biotech

Nod to Covaxin has been delayed further as WHO has more questions for Bharat Biotech. Know details

WHO experts group has sought additional clarifications on Covaxin

India made Covid vaccine Covaxin's wait for the WHO nod just got longer.
The World Health Organisation's technical advisory group on Tuesday sought "additional clarifications" from Covaxin maker Bharat Biotech to conduct a final "risk-benefit assessment" for Emergency Use Listing of the vaccine.
The technical advisory group will now meet on November 3 for a final assessment.
Hyderabad-based Bharat Biotech had submitted Expression of Interest to the WHO on April 19 for the vaccine's Emergency Use Listing.
The Covaxin has demonstrated 77.8 per cent effectiveness against symptomatic Covid-19 and 65.2 per cent protection against the new Delta variant. In June, the company said it concluded the final analysis of Covaxin efficacy from Phase 3 trials.

The technical advisory group will now meet on November 3 for a final assessment of Covaxin

India made Covid vaccine Covaxin's wait for the WHO nod just got longer.
The World Health Organisation's technical advisory group on Tuesday sought "additional clarifications" from Covaxin maker Bharat Biotech to conduct a final "risk-benefit assessment" for Emergency Use Listing of the vaccine.
Also watch:&nbsp;<a href="https://www.editorji.com/india-news/cannot-cut-corners-who-on-approving-india-s-covaxin-shot-1634574635105">'Cannot cut corners': WHO on approving India's Covaxin shot</a>
The technical advisory group will now meet on November 3 for a final assessment.
Hyderabad-based Bharat Biotech had submitted Expression of Interest to the WHO on April 19 for the vaccine's Emergency Use Listing.
"The TAG met on October 26 and decided that additional clarifications from the manufacturer are needed to conduct a final EUL risk-benefit assessment for global use of the vaccine," the WHO said in an email response to a question by PTI on the decision regarding the Emergency Use Listing of Covaxin.
"The TAG expects to receive these clarifications from the manufacturer by the end of this week, and aims to reconvene for the final risk-benefit assessment on Wednesday, 3 November," it added.
The Covaxin has demonstrated 77.8 per cent effectiveness against symptomatic Covid-19 and 65.2 per cent protection against the new Delta variant. In June, the company said it concluded the final analysis of Covaxin efficacy from Phase 3 trials.

Biotechnology company&nbsp;Bharat Biotech&nbsp;on Friday said that it has terminated the memorandum of understanding with to Precisa Medicamentos, for its Covid-19 vaccine Covaxin for the Brazilian market.&nbsp;
The termination of the MoU came after the deal with the Brazilian government for supply of 20 million doses of the vaccine landed in controversy and attracted investigation by authorities in Brazil.
Precisa Medicamentos is Bharat Biotech's partner in Brazil, providing assistance, guidance and support with regulatory submissions, licensure, distribution, insurance and conduct of phase III clinical trials, among others.
The Hyderabad-based vaccine maker said it will continue to work with Brazilian healthcare regulator Anvisa to obtain all required approvals for the use of Covaxin in the country.

Bharat Biotech terminates MoU with Brazilian partners amid corruption allegations

Amid allegations of irregularities, pharmaceutical firm Bharat Biotech has decided to terminate its deal with Brazil's Precisa Medicamentos to supply its Covid-19 vaccine Covaxin.

<ul>
<li>Bharat Biotech&nbsp;cancels agreement with Brazilian partners&nbsp;to supply Covaxin</li>
<li>Bharat Biotech&nbsp;had signed&nbsp;MoU for introducing Covaxin in&nbsp;Brazil</li>
<li>Vaccine maker to continue work with Brazilian healthcare regulator Anvisa</li>
<li>Brazil: probe into Prez&nbsp;Jair Bolsonaro&rsquo;s role in Covaxin scandal</li>
</ul>

<h2 class="article_desc">Bharat Biotech&nbsp;said it will continue to work with Brazilian healthcare regulator Anvisa to obtain all required approvals for the use of Covaxin in the country.</h2>

Biotechnology company&nbsp;Bharat Biotech&nbsp;on Friday said that it has terminated the memorandum of understanding with to Precisa Medicamentos, for its Covid-19 vaccine Covaxin for the Brazilian market.&nbsp;
The termination of the MoU came after the deal with the Brazilian government for supply of 20 million doses of the vaccine landed in controversy and attracted investigation by authorities in Brazil.
Precisa Medicamentos is Bharat Biotech's partner in Brazil, providing assistance, guidance and support with regulatory submissions, licenses, distribution, insurance and conduct of phase III clinical trials, among others.
The Hyderabad-based vaccine maker said it will continue to work with Brazilian healthcare regulator Anvisa to obtain all required approvals for the use of Covaxin in the country.

The Hyderabad-based pharmaceutical firm said it has not received advance payments from the Brazilian health ministry.

Bharat Biotech on 'Brazil Covid scam': Covaxin-maker says followed 'step-by-step approach for approval'

The Hyderabad-based pharmaceutical&nbsp;firm said&nbsp;it has not received advance payments from the Brazilian health ministry.

India&rsquo;s Bharat Biotech said on Wednesday it followed a &ldquo;step-by-step" approach for the regulatory approval and supply contract of its COVID-19 vaccine in Brazil.&nbsp; Brazil&rsquo;s health minister said on Tuesday the country will suspend its $324 million contract for 20 million doses of Bharat Biotech&rsquo;s vaccine after whistleblowers went public with alleged irregularities in the deal. The Hyderabad-based vaccine maker said that it has not received advance payments from the Brazilian health ministry. Brazilian federal prosecutors have opened an investigation into the deal citing comparatively high prices, quick talks and pending regulatory approvals as red flags for the contract signed in February.
Accusations that Brazilian President Jair Bolsonaro turned a blind eye to possible corruption in a deal to purchase coronavirus vaccines have heightened threats to his presidency.&nbsp; Bharat Biotech&nbsp;said it&nbsp;has followed a similar approach towards contracts, regulatory approvals and supplies in several countries worldwide, where Covaxin is being supplied successfully.

The Hyderabad-based pharmaceutical&nbsp;firm said&nbsp;it has not received advance payments from the Brazilian health ministry.

India&rsquo;s Bharat Biotech said on Wednesday it followed a &ldquo;step-by-step" approach for the regulatory approval and supply contract of its COVID-19 vaccine in Brazil.&nbsp; &ldquo;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. Brazil&rsquo;s health minister said on Tuesday the country will suspend its $324 million contract for 20 million doses of Bharat Biotech&rsquo;s vaccine after whistleblowers went public with alleged irregularities in the deal. The Hyderabad-based vaccine maker said that it has not received advance payments from the Brazilian health ministry. 
Brazilian federal prosecutors have opened an investigation into the deal citing comparatively high prices, quick talks and pending regulatory approvals as red flags for the contract signed in February.
Accusations that Brazilian President Jair Bolsonaro turned a blind eye to possible corruption in a deal to purchase coronavirus vaccines have heightened threats to his presidency.&nbsp; Bharat Biotech&nbsp;said it&nbsp;has followed a similar approach towards contracts, regulatory approvals and supplies in several countries worldwide, where Covaxin is being supplied successfully.

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