Bharat Biotech may need at least 6 months to address deficiencies

Bharat Biotech may need at least 6 months to address deficiencies

The company sources said that the WHO decision doesn’t impact the supply of Covaxin as no orders from the UN agencies are pending.

It may take at least 6-8 months for Hyderabad-based Bharat Biotech — the manufacturer of Covid-19 vaccine Covaxin — to upgrade its facilities to address the Good Manufacturing Practice (GMP) deficiencies flagged by the WHO, company sources said.

On Saturday, the WHO had suspended the procurement of Covaxin by UN agencies, asking Bharat Biotech for facility upgrade to address the identified GMP deficiencies. The WHO, however, had highlighted that Covaxin is effective and no safety concern exists.

Company sources told The Indian Express that the specific upgrade could not have been undertaken in the middle of the pandemic since the supply of new equipment takes 15-18 months and it also requires complete shutdown of the facilities, which could have resulted in delay in the supply of the vaccine.

“Equipment upgrade is not something you can buy off the shelf,” sources said.

The company sources said that the WHO decision doesn’t impact the supply of Covaxin as no orders from the UN agencies are pending. They also said the WHO directive doesn’t have any impact on supply of the vaccine in approximately 25 countries, where the company has received Emergency Use Authorisation.

“The company has not received any order till date from any of these UN agencies. The company has supplied Covaxin to India’s immunisation drive and 25 other countries. This order impacts only the supply to UN agencies,” sources said.

“Bharat Biotech facilities were not designed for producing Covaxin. These were re-purposed facilities: some were polio virus vaccine facilities; and others were for rabies and Japanese encephalitis vaccine. When we started manufacturing Covaxin in these facilities, we undertook a risk assessment and manufactured it in a manner where the vaccine is safe,” sources said.

Bharat Biotech may need at least 6 months to address deficiencies
Bharat Biotech temporarily 'slows down' Covaxin production due to decrease in demand

Sources said that based on the inspection, WHO has directed the company to upgrade the facilities, including equipment. “We have promised WHO that the GMP standards will be met at the facility that will manufacture Covaxin,” sources said.

Sources said the company has not yet taken a decision on which facility will be upgraded for manufacturing Covaxin.

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