Brazilian health regulator Anvisa has approved the import of India’s Covaxin jab, which is now waiting for WHO’s approval.

Brazil Approves Covaxin For Import, WHO Approval 'Will Be Achieved Soon'

by Bhaswati Guha Majumder - Saturday, June 5, 2021 02:15 PM IST
Brazil Approves Covaxin For Import, WHO Approval 'Will Be Achieved Soon'Bharat Biotech’s COVAXIN 

As India is looking forward to World Health Organization’s (WHO) approval for Hyderabad based Bharat Biotech’s Covaxin jab, the Center said that “the milestone will be achieved soon”.

During a news conference on the Covid-19 situation in India, Dr VK Paul, Member (Health) Niti Aayog, said that the authorities have been working with Bharat Biotech and WHO, data exchange is underway and we are keen that this milestone is accomplished soon.

Meanwhile, on 4 June, Anvisa, which is Brazil's health agency, approved imports of Russia's Sputnik V as well as India's Covaxin (BBV152 COVID-19) vaccinations—but with conditions on both the jabs.

Anvisa's board voted 4-1 to reject Brazilian states' requests for Sputnik V in April—due to a lack of data on safety, quality and effectiveness—as well as to reject Covaxin in March due to Good Manufacturing Practices (GMP) issues.

At that time, Brazil’s health agency said: "Regarding the fulfilment of GMP by the manufacturer Bharat Biotech, one of the main aspects that motivated the previous decision, the company filed a new certification request at Anvisa, referring to the production line of the finished product."

But after getting a red flag from the Brazilian health regulator, the Covaxin makers filled another request to the Brazilian authorities for certification.

As per the reports, Bharat Biotech filed the request on 25 May, a day before the South American country's Ministry of Health filed a new application for permission to import 20 million doses of Covaxin.

In the case of WHO’s approval, Bharat Biotech said in May that it had submitted 90 per cent of the documentation needed for WHO’s Emergency Use Listing (EUL) and the rest will be shared in June.

A WHO designation for Covaxin Covid-19 jab would help Indian vaccine research, while at least four other India-developed vaccine candidates are currently undergoing clinical trials.

The Indian foreign ministry has been working with Bharat Biotech to get the vaccine recognised by the UN agency.

It's also possible that several countries may only allow travellers who got the WHO-approved vaccines.

In such a case, if the Indian vaccine receives the green signal from the global healthcare agency, it will make travel easier for those who received Covaxin, specifically the Indians.

Meanwhile Covaxin has received regulatory approval in more than 60 countries, said Bharat Biotech.The vaccine manufacturer also said that the Emergency Use Authorisations (EUA) have been obtained in 13 countries.

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