The World Health Organization (WHO) has confirmed it has suspended the supply of Covaxin, produced by city-based Bharat Biotech, through UN procurement agencies and recommending to countries that received the covid vaccine to take actions as appropriate.
A statement issued by WHO on Saturday said the suspension is in response to the outcomes of its post EUL (emergency use authorisation) inspection held between March 14-22, 2022 and the need to conduct process and facility upgrade to address recently identified GMP (good manufacturing practice) deficiencies.
There will be interruption of supply of Covaxin due to suspension of production for export, WHO said. The risk assessment to date does not indicate change in the risk-benefit ratio. The data, available to WHO, indicate the vaccine is effective and no safety concern exists, WHO said. Bharat Biotech on April 1 announced the temporary slowing down of production of its covid-19 vaccine Covaxin across its manufacturing facilities, having completed its supply obligations to procurement agencies and foreseeing the decrease in demand.
During the recent WHO inspection, Bharat Biotech agreed with the former’s team on the scope of the planned improvement activities and indicated that they will be executed as soon as possible.
The company has committed to comply by addressing the GMP deficiencies and is developing a corrective and preventive action plan, for submission to the Drugs Controller General of India (DCGI) and WHO.
In the interim and as a precautionary measure, the company has indicated its commitment to suspend its production of Covaxin for export, WHO said.
The decision from WHO came immediately after India and Russia made a 15 million barrels oil contract for this year. India has maintained a softer stance against Russia’s action while the U.S. and its allies have tried to isolate and punish Moscow over the invasion of its neighbor. It is also to note that WHO is asking for donations for Ukraine through its website. It is also important to point here that COVAXIN was given EUL very lately while it has least side effects as compared to Moderna, Pfizer and Astrazeneca’s vaccine. So is it a strategy to hurt India’s pharma industry after India’s stand on Russia-Ukraine war in international political scenario or are there serious discrepancies in production facilities.
