As the World Health Organization (WHO) announced the suspension of the supply of Covaxin through United Nations supply agencies, Bharat Biotech sources said on Monday that the pharmaceutical company had no provided the COVID-19 vaccine to any UN agency and that no impact of the suspension would be felt.
So far, according to sources, the company has supplied vaccines to the Indian government and nine countries under the Centre’s Vaccine Maitri program, and has made direct commercial supply under a medical use authorization. ’emergency.
Covaxin has received emergency use approvals from more than 25 countries “We have not received any orders from any UN agency so far,” a source said. Gavi Covax, the international vaccine alliance, has also not placed any orders for Covaxin.
Citing shortcomings in good manufacturing practices (GMP), the World Health Organization (WHO) on April 2 confirmed the suspension of the supply of Covaxin through United Nations supply agencies and has recommended that countries that have received the vaccine take appropriate action. In a statement, the WHO said this suspension responds to the results of the WHO’s post-emergency use list (EUL) inspection and the need for an upgrade of processes and procedures. facilities to address recently identified GMP deficiencies.
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During the facility upgrade, company sources said Monday that none of the facilities where Covaxin is manufactured were designed specifically to manufacture Covaxin. These are repurposed facilities, which already existed for the manufacture of other vaccines.
“We will retrofit existing facilities and make them 100% specific for Covaxin,” the source said. Our vaccine certificates remain valid and there will be no interruption of supply in India, the source said.
WHO officials conducted an inspection of the BB facility from March 14-22. It was not a surprise visit, the sources said, adding that there was no inspection before the EUL was granted and the WHO audit was only for Covaxin.
The source said that once all facility upgrades are completed, “we will apply to the WHO for a full license for Covaxin” in due course. In response to a question about the nasal vaccine, the company source said the phase 3 trial is continuing and in four months they will have the data as it is a very complex trial.
“After analyzing the data, we will decide whether to do further testing or apply for a license,” the source said.
The WHO had said that Bharat Biotech had committed to comply by correcting the GMP deficiencies and was developing a corrective and preventive action plan, to be submitted to the Drug Controller General of India DCGI and the WHO.
In the meantime and as a precautionary measure, Bharat Biotech has indicated its commitment to suspend its production of Covaxin for export, the WHO had indicated. The WHO said the risk assessment to date does not indicate a change in the risk-benefit ratio. The data, available to WHO, indicates that the vaccine is effective and that there are no safety concerns.
Bharat Biotech also said the WHO announcement will not impact Ocugen trials. Ocugen had entered into an agreement with Bharat Biotech to develop, supply and market Covaxin for the US market.
The FDA has cleared Covaxin’s Phase 2-3 adult clinical trial application. Bharat Biotech hit its $1 billion annualized maximum capacity for Covaxin last month.