Bharat Biotech on WHO's Covaxin supply suspension: No impact on efficacy, safety

Indian biotechnology company Bharat Biotech on Sunday issued a clarification over the suspension of its Covid-19 vaccine supplies by the World Health Organisation (WHO) through UN procurement agencies. The Hyderabad-based company said in a statement that there is "no impact on efficacy and safety of the Covid-19 vaccine COVAXIN".

"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," the statement read. 

On Saturday, the UN health agency suspended the supply of Covaxin under the Covax facility, attributing it to deficiencies in manufacturing practices.

"The World Health Organisation (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 UN agency said in a statement.

The suspension was announced following the WHO post-emergency use listing inspection conducted between March 14 -22. The inspection highlighted the need to conduct process and facility upgrades to address recently identified good manufacturing practice (GMP) deficiencies.

Bharat Biotech said it is slowing down the production of Covaxin for 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, these upgrades were due. Certain highly sophisticated equipment which was required to enhance the process stringency was unavailable during the Covid-19 pandemic. It has to be stressed that the quality of COVAXIN was never compromised at any point in time," it added.

As a result, there will be an interruption of the supply of Covaxin.

The company insisted that it is "diligently working to further improvements and upgrades to ensure that the production of COVAXIN continues to meet ever-increasing global regulatory requirements." 

"Since patient safety is the primary consideration for any new vaccine, there can be no compromises in meeting operational excellence objectives," it added.

The WHO also said that the risk assessment to date does not indicate a change in the risk-benefit ratio, with no issues related to the safety and efficacy of a vaccine.

'The data available to WHO, indicate the vaccine is effective and no safety concern exists. For continuation of vaccination with alternative sources of Covid19 vaccines countries should refer to the respective SAGE recommendation," the statement read.