US FDA denies emergency use approval for Covaxin

The US Food and Drug administration has denied approval for emergency use of Covaxin developed by Hyderabadbased Bharat Biotech and has asked for additional data biopharmaceutical Ocugen the US partner of the Indian vaccine maker has saidThe FDA recommended Ocugen to pursue a Biologics Licence Application BLA submission instead of an EUA application and requested additional information and dataThe company anticipates that data from an additional clinical trial will be required to support the submissionAlthough we were close to finalising our EUA application for submission we received a recommendation from the FDA to pursue a BLA path While this will extend our timelines we are committed to bringing Covaxin to the USThis differentiated vaccine is a critical tool to include in our national arsenal given its potential to address the SARSCoV2 variants including the delta variant and given the unknowns about what will be needed to protect US population in the long term said Shankar Musunuri Chairman of the Board Chief Executive Officer and Cofounder of Ocugen in a statement on ThursdayOcugen recently announced that it secured exclusive rights to commercialise Covaxin in Canada and has initiated discussions with Health Canada for regulatory approvalThe Company will pursue expedited authorisation for Covaxin under the Interim Order Respecting the Importation Sale and Advertising of Drugs for Use in Relation to Covid19 in Canada the statement saidCovaxin has so far emerged safe in clinical trials to date said Bruce Forrest Acting Chief Medical Officer and member of the vaccine scientific advisory board of OcugenThe Ministry of Health and Family Welfare of Republic of India reported no potential thromboembolic events following the administration of over 67 million doses of Covaxin Forrest addedBharat Biotech developed Covaxin in collaboration with the Indian Council of Medical Research ICMR National Institute of Virology NIVIt is an inactivated vaccine that is manufactured using a vero cell manufacturing platform Covaxin has showed strong results in all the studies conducted to date including a vaccine efficacy rate of 78 per cent overall efficacy and 100 per cent in severe Covid19 disease including hospitalisations in second interim results of Bharat Biotechs Phase 3 clinical trialCovaxin studies show that it effectively neutralised the Brazil variant of SARSCoV2 B11282 the alpha variant B117 which was first identified in the UK as well as the delta variant B1617 which was first identified in IndiaMore than 30 million doses have been supplied in India and other countries Itis currently being administered under emergency use authorisations in 13 countries and applications for emergency use authorisation are pending in more than 60 additional countriesThis 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