World Health Organization (WHO) in a statement issued on April 2nd confirmed the suspension of Covaxin produced by Bharat Biotech, through UN procurement agencies and gave recommendations to the countries that received the vaccine to take action as appropriate.
This suspension came after a EUL inspection done from 14th March to 22nd March 2022 and in a statement WHO quoted “This suspension is in response to the outcomes of WHO post-Emergency Use Listing (EUL) inspection (14-22 March 22) with the need to conduct process and facility upgrade to address recently identified GMP deficiencies (Refers to good manufacturing practices deficiencies) there’ll be an interruption of supply of Covaxin due to suspension of production for export”.
WHO also added, “Bharat 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, Bharat has indicated its commitment to suspend its production of Covaxin for export.
Does it raise any safety concerns?
The risk assessment to date does not indicate a change in the risk-benefit ratio and is available to WHO indicating the vaccine is effective and no safety concern exists.
On 1st April, Bharat Biotech issued a statement announcing the “temporary slowing down of Covaxin production for facility optimization across its manufacturing facilities, having completed its supply obligations to procurement agencies and foreseeing a decrease in demand.
For the coming period, the company said they’ll focus on pending facility maintenance, process, and facility optimization activities, as all existing facilities were repurposed for the manufacture of Covaxin with continuous production during the past year to meet the public health emergency of COVID-19 for which the upgrades were due.
Certain highly sophisticated equipment which was required to enhance the process stringency was unavailable during the COVID-19 pandemic but it has to be stressed that the quality of Covaxin was never compromised at any point in time.
Will the vaccine certificate be valid?
The company had said that for the millions who had received Covaxin, the vaccine certificates issued still stood valid as there was no impact on the efficiency and safety of the vaccine.
Covaxin is an inactivated vaccine, developed with Whole-Virion Inactivated Vero cell-derived technology and has been prepared on a tried and tested platform of dead viruses. It contains inactivated viruses, which cannot infect a person but still can teach the immune system to prepare a defense mechanism against the active virus.
Bharat Biotech further added, “This risk assessment by the WHO is based on the supply of hundreds of millions of doses of Covaxin globally during which the product has demonstrated an excellent safety and efficiency profile in detailed and thorough post-marketing surveillance activities.”
Published By – Damandeep Singh
Edited By- Kritika Kashyap
