The World Health Organization (WHO) decision to suspend Covaxin supply through United Nations (UN) agencies is not a setback for Bharat Biotech, sources in the company that made the indigenous Covid-19 vaccine told CNN-News18 on Monday.
The suspension came after an inspection for ’emergency-use listing’ between March 14 and 22. The WHO pointed out that there was a need to conduct process and facility upgrades to address recently identified good manufacturing practice (GMP) deficiencies.
“Any company manufacturing Covid vaccines had not designed facilities for it. These were repurposed for Covid. The design was not 100% Covid vaccines manufacturing,” the Bharat Biotech sources said.
The WHO said on Saturday that it is “confirming the suspension of supply of Covaxin produced by Bharat Biotech, through UN procurement agencies and recommending to countries that received the vaccine to take actions as appropriate.” The international health body, however, maintained that data available on the vaccine indicated that it was effective and there were no safety concerns.
On the matter of facility upgrade, the Bharat Biotech sources said, “We have committed to the United Nations that we will upgrade the facility and perfectly design it for future with required upgrades. It takes 24 months when you order for an upgrade in the facility in the pandemic. And our manufacturing process takes four months.”
The Hyderabad-based company also intends to apply for a full WHO licence for the vaccine in the future, said the sources.
The inactivated virus-based vaccine was cleared for emergency use in India in early January 2021 and it was rolled out along with Covishield — made in India by the Pune-based Serum Institute under licence from its developers Oxford-AstraZeneca — as a mainstay of India’s vaccination drive that got underway on January 16.
Covaxin got WHO listing in November 2021. Over 30 crore doses of the vaccine have been administered in India so far, according to data available, and it also received emergency-use authorisation in over a dozen countries.
A day before the WHO announced the suspension move, Bharat Biotech said it was temporarily slowing down Covaxin production across its manufacturing units for facility optimisation as it had already completed its supply obligations to procurement agencies and expected a decrease in demand.
“For the coming period, the company will focus on pending processes, facility maintenance, and facility optimisation activities,” the sources told CNN-News18 on Monday.
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