Covaxin supply to Brazil hits a roadblock

April 01, 2021 12:00 am | Updated 06:14 am IST - NEW DELHI

ANVISA not to clear doses now

Earlier this week, 1 lakh doses of Covaxin were donated by India to Paraguay.

Earlier this week, 1 lakh doses of Covaxin were donated by India to Paraguay.

Supplies of Bharat Biotech’s Covaxin to Brazil have run into trouble with Brazil’s health regulatory agency, ANVISA, deciding on Tuesday not to clear Covaxin for use at present.

In a statement protesting the decision, Covaxin’s Brazilian import partner Precisa Medicamentos (PM) said it would appeal the ANVISA decision, which, diplomatic sources said, was more about “bureaucratic process” and not pertaining to the quality of the vaccine. In particular, ANVISA required a certification of “manufacturing good practices”, which needs to be submitted before the clearances can be given.

As part of its procedure, representatives from ANVISA visited Bharat Biotech’s factory in India from March 1 to 5 and “all notes raised by the agency” were recorded, said PM in the translated version of its press statement. During the inspection, the regulatory agency reportedly required more stringent “technical and documentation procedures”.

“The requirements pointed out during inspection will be fulfilled, the timelines for fulfilment is under discussion with the Brazil NRA [National Regulatory Agency] and will be resolved soon. The 20 million dose order from the Brazilian Govt is still active. The agreement with Precisa Medicamentos is based on a long term partnership and will continue,” a spokesperson from Bharat Biotech told The Hindu , reacting to the ANVISA decision.

Bharat Biotech said it had agreed to the conditions laid by ANVISA but found the deadlines for compliance too tight, offering to complete procedures by June, rather than April, which may have led to the denial of clearances, the sources said.

Import partner

“The fulfilment of ANVISA’s notes in the shortest time would only be possible by interrupting Covaxin’s production completely, consequently affecting the supply to countries that have already received the product and have already authorised its emergency use, which is extremely inconsistent and imprudent in this current world situation,” the PM statement said, pointing out that Brazilian laws allow the vaccine to be authorised nevertheless for emergency and exceptional use, even without the certification.

The development follows weeks after Serum Institute of India (SII) had informed Brazil’s state-owned vaccine importer Fiocruz that supplies of further Covishield (AstraZeneca) doses could not be guaranteed because a fire in an SII building had hampered manufacturing.

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