THE World Health Organisation (WHO), has with immediate effect, suspended the supply of the Indian manufactured COVAXIN shots following the outcome of an inspection in March 2022, where deficiencies and manufacturing related concerns were identified.
By Michael Gwarisa
The decision by WHO has also prompted Bharat Biotech, the manufacturer to immediately suspend production of Covaxin, a move that is set to interrupt the vaccination programs for countries relying on Covaxin to carry out immunisations.
Countries that had approved the use of COVAXIN include Zimbabwe, Australia, Mauritius, Oman, Philippines, Nepal, Mexico, Iran, Sri Lanka, Greece and Estonia.
WHO confirmed the suspension of supply of Covaxin (Bharat Biotech) through UN procurement agencies, and recommended that countries using the vaccine take action as appropriate. The suspension is in response to the outcome of a WHO inspection on 14–22 March 2022, and the need to conduct process and facility upgrade to address recently identified deficiencies in good manufacturing practices (GMP),” said WHO in statement.
They however added that Bharat Biotech has since committed to 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 that it will suspend production of Covaxin for export. As a consequence, supply will be interrupted for the foreseeable future.”
The risk assessment to date however does not indicate change in the risk–benefit ratio and the data, available to WHO indicate the vaccine is effective and no safety concerns exist. For continuation of vaccination with alternative sources of COVID-19 vaccines, WHO urged countries to refer to the respective SAGE recommendations.
This is however not the first time supply of the Covaxin jabs has been interrupted. In May of 2021, Zimbabwe received a shipment of 35,000 COVAXIN jabs from India, however supply was interrupted by the emergence of the Delta variant, leading to some Zimbabweans going for an additional six months without receiving their second jabs.