WHO Suspends Covaxin Supply Through UN Agencies, Bharat Biotech Says No Impact On Vaccine's Efficacy

The World Health Organization (WHO) has suspended supply through United Nations (UN) procurement agencies of the Bharat Biotech BBV152 COVAXIN vaccine against Covid-19.

Covaxin | Getty Images

New Delhi: The World Health Organization (WHO) has suspended supply through United Nations (UN) procurement agencies of the Bharat Biotech BBV152 COVAXIN vaccine against Covid-19, the UN health agency said on Saturday. 

The WHO made this move to allow Bharat Biotech to upgrade facilities and address deficiencies found in an inspection. In a statement, the UN health agency asked countries that have received the vaccine to take appropriate actions. The WHO, however, did not specify what appropriate actions must be taken, according to media reports.

WHO Suspends Supply Of Covaxin Through UN Procurement Agencies

The UN health agency said: "The World Health Organization (WHO) is today 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."

The WHO said that Covaxin is effective and no safety concerns exist, but the suspension of production for export, which is in response to the outcomes of WHO post emergency use listing (EUL) inspection conducted from March 14 to 22, and the need to conduct process and facility upgrade to address recently identified good manufacturing practice (GMP) deficiencies, will result in the interruption of Covaxin supply. According to a report by news agency Reuters, Bharat Biotech has indicated its commitment to suspend production of Covaxin for export. 

The UN health agency said that Bharat Biotech 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". 

'No Impact On Efficacy & Safety Of The Covid-19 Vaccine Covaxin': Bharat Biotech

Bharat Biotech said in a statement on Sunday that there is "no impact on efficacy and safety of the COVID-19 vaccine COVAXIN".

The vaccine manufacture also said that for the millions who received COVAXIN, the vaccine certificates issued still stand valid as there is no impact on efficacy and safety of the vaccine."

The vaccine manufacturer said in a statement on Friday that it was slowing production of Covaxin. This is because the demand was dropping along with a fall in infections and wider immunisation coverage in the country.

"For the coming period, the company will focus on pending facility maintenance, process and facility optimization activities," Bharat Biotech said in the statement, according to media reports.

The company also said that it was making appropriate changes in manufacturing processes to match WHO standards.

"During the recent WHO post EUL inspection, Bharat Biotech agreed with the WHO team on the scope of the planned improvement activities and indicated that they will be executed as soon as practical,” Bharat Biotech said in the statement.

“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, these upgrades were due. Certain highly sophisticated equipment which were required to enhance the process stringency were unavailable during the COVID-19 pandemic. It has to be stressed that the quality of COVAXIN was never compromised at any point in time," the vaccine manufacturer further said.

The supply of Covaxin will be interrupted as a result of the suspension of production for export.

WHO Clarifies Covaxin Is Effective

The WHO, however, clarified in its statement that Covaxin is effective and no safety concern exists. "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. For continuation of vaccination with alternative sources of Covid-19 vaccines countries should refer to the respective SAGE recommendation," the UN health agency said in the statement. The Strategic Advisory Group of Experts on Immunization (SAGE) is responsible for advising WHO on overall global policies and strategies.

Bharat Biotech's Covaxin, Zydus Cadila's ZyCoV-D, and Biological E's Corbevax are the three indigenously developed Covid-19 vaccines in India.