Bharat Biotech on WHO’s Covaxin supply suspension: No impact on efficacy, safety | Latest News India

Indian biotechnology company Bharat Biotech on Sunday issued a clarification over the suspension of its Covid-19 vaccine provides by the World Health Organization (WHO) via UN procurement businesses. The Hyderabad-based company mentioned in an announcement that there’s “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 assertion learn. 

On Saturday, the UN well being company suspended the supply of Covaxin below the Covax facility, attributing it to deficiencies in manufacturing practices.

“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 UN company mentioned in an announcement.

The suspension was introduced following the WHO post-emergency use itemizing inspection carried out between March 14 -22. The inspection highlighted the necessity to conduct course of and facility upgrades to deal with lately recognized good manufacturing apply (GMP) deficiencies.

Bharat Biotech mentioned it’s slowing down the manufacturing of Covaxin for pending facility upkeep, course of and facility optimization actions.

“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 consequence, there will likely be an interruption of the supply of Covaxin.

The company insisted that it’s “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 additionally mentioned that the danger evaluation up to now doesn’t point out a change within the risk-benefit ratio, with no points associated to the safety and efficacy of a vaccine.

‘The knowledge out there to WHO, point out the vaccine is efficient and no safety concern exists. For continuation of vaccination with different sources of COVID19 vaccines international locations ought to check with the respective SAGE suggestion,” the assertion learn.

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