Bharat Biotech: WHO suspension of the supplies of Covaxin has little impact on efficacytext_fields
The World Health Organisation disallowed the distribution of COVID-19 vaccine Covaxin, produced by India's Bharat Biotech, through UN agencies to allow the manufacturer to upgrade facilities and address deficiencies found during an inspection.
According to the statement, WHO asked recipients of the vaccine to take appropriate action, but did not specify what those actions should be.
WHO considers it to be "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."
In spite of the fact that the vaccine is effective and there are no safety concerns, the suspension of export production will result in an interruption of the Covaxin supply.
As a result of findings from an emergency use listing (EUL) inspection conducted by WHO from March 14-22, the vaccine maker intends to halt exports of Covaxin.
A statement released today by Hyderabad-based Bharat Biotech claims there is "no impact on the efficacy and safety of COVID-19 vaccine Covaxin."
According to news agency ANI, Bharat Biotech said in the statement, "For the millions who have received Covaxin, the vaccine certificates issued still stand valid as there is no impact on efficacy and safety of the vaccine."
In order to optimize its production facilities, Bharat Biotech is reducing production of Covaxin.
"For the coming period the company will focus on pending facility maintenance, process and facility optimization activities," it stated.
According to the WHO, the company has "committed to comply by addressing the GMP (good manufacturing practice) deficiencies and is developing a corrective and preventive action plan, for submission to the Drugs Controller General of India (DCGI) and WHO".