Brazil Health board authorises import of Covaxin & Sputnik V; here are the conditions

In a major relief for Bharat Biotech (BBL)'s Covaxin and Russia's Sputnik V, Brazil's National Health Surveillance Agency (ANVISA) authorised their import by the Ministry of Health on Friday, for distribution and use under controlled conditions. In 4:1 vote the ANVISA board rejected the government's request to ban Sputnik V due to lack of data, safety, quality and effectiveness and to ban Covaxin as it did not meet manufacturing standards. As per the ANVISA's approval, Covaxin has been allowed to be imported to Brazil after improvements were made to BBL's factory as per Brazilian standards.

Brazil's health board allows import of Sputnik V & Covaxin

Key conditions for import of Covaxin as per ANVISA:

• All consignments for Brazil have been manufactured after the adjustments of Good Manufacturing Practices (GMP) are implemented By Bharat Biotech
• All batches to be sent to Brazil must be accompanied by certificates of analysis attesting to the performance of the potency test.
•  All batches to be sent to Brazil must be accompanied by microbiological sterility reports
• The vaccine should only be used to immunize adults of 18 years and < 60 years
• The vaccine should not be used in pregnant women, postpartum women, breastfeeding women and individuals with comorbidities
• The batches of vaccines imported will be intended for use after release by laboratory analysis and INCQS.

BBL had filed a fresh request to the Brazilian authorities for Good Manufacturing Practices (GMP) certification on 27 May after Brazil's health regulator flagged manufacturing issues in its plant. On February 26, BBL had signed an agreement with the Brazilian government for the supply of 20 million doses of Covaxin during the second and third quarters of the current year. However, due to the GMP issues, the Brazilian health regulator refused to import the vaccine into the country.

What were the GMP issues?

As per ANVISA's report, BBL had skipped key steps in ensuring that the virus in Covaxin was fully killed, or was incapable of multiplying in the human body. The report had also highlighted possible variations in Covaxin’s potency from one dose to another. In response, BBL told PTI that the requirements pointed out during inspection will be fulfilled and that the timelines for fulfillment "is under discussion with  Brazil and will be resolved soon".