This is an archive article published on April 5, 2022
Bharat Biotech may need at least 6 months to address deficiencies
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.
The Covid-19 vaccine manufacturing scale-up has seen 372 partnerships forged, of which 88 per cent (329) include technology transfer or fill and finish. (File)
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.
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“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.
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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.
Kaunain Sheriff M is an award-winning investigative journalist and the National Health Editor at The Indian Express. He is the author of Johnson & Johnson Files: The Indian Secrets of a Global Giant, an investigation into one of the world’s most powerful pharmaceutical companies.
With over a decade of experience, Kaunain brings deep expertise in three areas of investigative journalism: law, health, and data. He currently leads The Indian Express newsroom’s in-depth coverage of health.
His work has earned some of the most prestigious honours in journalism, including the Ramnath Goenka Award for Excellence in Journalism, the Society of Publishers in Asia (SOPA) Award, and the Mumbai Press Club’s Red Ink Award.
Kaunain has also collaborated on major global investigations. He was part of the Implant Files project with the International Consortium of Investigative Journalists (ICIJ), which exposed malpractices in the medical device industry across the world. He also contributed to an international investigation that uncovered how a Chinese big-data firm was monitoring thousands of prominent Indian individuals and institutions in real time.
Over the years, he has reported on several high-profile criminal trials, including the Hashimpura massacre, the 2G spectrum scam, and the coal block allocation case. Within The Indian Express, he has been honoured three times with the Indian Express Excellence Award for his investigations—on the anti-Sikh riots, the Vyapam exam scam, and the abuse of the National Security Act in Uttar Pradesh. ... Read More
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