Brazil’s denial of emergency use licence to Bharat Biotech International’s Covaxin on the grounds of allegedly serious lapses at its Hyderabad facility may make other health regulators as well as the World Health Organization reluctant to authorize the Indian-made covid vaccine, experts said.

Others said Bharat Biotech may still end up meeting the requirements of the Brazilians.

On Tuesday, Brazil’s Agencia Nacional de Vigilancia Sanitari, or Anvisa, said it found the company violating norms for good manufacturing practices during an inspection in March. It said the company could not validate the method used to inactivate, or kill, the virus, which could lead to people being injected with the covid virus.

“Anvisa’s observations could become a significant issue for Bharat Biotech, especially if it approaches WHO and foreign regulators for an emergency licensure. Other regulators will ask about the process to inactivate the virus,” a vaccine industry official said on condition of anonymity.

The process is important as live virus particles in a vaccine could potentially put a ‘beneficiary’ at risk of contracting covid-19 instead of protecting him, the official added.

Bharat Biotech said on Wednesday, “The requirements pointed out during inspection will be fulfilled. The timelines are under discussion and will be resolved.” It added that Brazil’s order for 20 million doses is active. It has signed a deal with US biopharma firm Ocugen Inc. for co-developing, supplying and commercializing Covaxin in the US.

Anant Bhan, a bioethics expert, said Anvisa’s observations could lead to some regulators, such as US FDA, visiting the facilities when its seeks emergency use authorisation.

“What might be important for WHO will be efficacy. For other regulators, this (Anvisa’s observation) may raise concerns and some might want some more clarity while, maybe, others might also want to do an inspection.”

Gagandeep Kang, professorat Christian Medical College, Vellore, said Anvisa’s observations do not mean the product has failed and that the vaccine may still end up meeting regulations. “But these are things the company has to take seriously and the Indian regulator must also take note.”

Emailed queries to Drugs Controller General of India V.G. Somani and the spokesperson of the health ministry on Wednesday did not elicit a response.

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