No impact on efficacy and safety of Covaxin: Bharat Biotech after WHO suspension

Hyderabadbased Bharat Biotech on Sunday issued a clarification that there is no impact on efficacy and safety of the Covid19 vaccine COVAXIN after the World Health Organisation suspended it from its Covax facility 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 read the statement issued by Bharat Biotech on suspension from WHOThe vaccine manufacturer has further said that the company is slowing down the production of Covaxin for facility optimization For the coming period the company will focus on pending facility maintenance process and facility optimization activities the statement readAs all existing facilities were repurposed for the manufacture of COVAXIN with continuous production during the past year to meet the public health emergency of Covid19 these upgrades were due Certain highly sophisticated equipment which was required to enhance the process stringency was unavailable during the Covid19 pandemic It has to be stressed that the quality of COVAXIN was never compromised at any point in time it addedThe company also mentioned that they are working to further improvements and upgrades to ensure that the production of COVAXIN continues to meet the increasing global regulatory requirements Notwithstanding this excellent safety and efficacy record Bharat Biotech is diligently working to further improvements and upgrades to ensure that the production of COVAXIN continues to meet everincreasing 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 saidThe Bharat Biotechs Covid19 vaccine COVAXIN has been suspended by World Health Organization WHO from its Covax facility announced the UN health body on Saturday attributing it to deficiencies in manufacturing practices WHO confirms 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 reads the WHO in a statement However the UN body clarified that there will be no issues related to the safety and efficacy of a vaccineThe risk assessment to date does not indicate a change in the riskbenefit ratio 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 it read On inspection by WHO Bharat biotech said During the recent WHO postEUL 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 practicalIt does not indicate a change in the riskbenefit ratio for COVAXIN and the data available to WHO indicates the vaccine is effective and no safety concern exists it said This suspension has been done after the WHO postemergency use listing inspection that was conducted between March 1422 After the suspension there will be an interruption of supply of Covaxin production for exportThis story has been sourced from a third party syndicated feed agencies Midday accepts no responsibility or liability for its dependability trustworthiness reliability and data of the text Midday managementmiddaycom reserves the sole right to alter delete or remove without notice the content in its absolute discretion for any reason whatsoever