In a boost for India's maiden indigenously developed COVID-19 vaccine, Brazilian health regulator Anvisa has given the nod to "exceptional import" of Hyderabad-based Bharat Biotech's Covaxin, Times of India.
It should be noted that as per a loosely translated version of Anvisa's announcement, the body has given the approval for an initial four million doses of Covaxin for distribution and use "under controlled" and specific conditions.
Upon the use of these four million doses, Anvisa will analyse the data to assess the further quantities of Covaxin to be imported.
It should be noted that back in March, Anvisa had turned down the first import request made by the Brazilian Health Ministry. After this, the Ministry approached Anvisa again in May. Bharat Biotech had also approached Anvisa in May end seeking approval for two Good Manufacturing Practices (GMP) implemented by it.
In this light, announcing the approval for Covaxin, Anvisa took note of the improvements made in the manufacturing line at Bharat Biotech's facility in India.
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