WHO to take final decision next week on approval to Bharat Biotech’s Covaxin

The World Health Organization said on Tuesday that it will make a decision on granting emergency use listing (EUL) to Bharat Biotech‘s Covid-19 vaccine next week.

WHO and an independent group of experts are scheduled to meet next week to carry out the risk, benefit assessment and come to a final decision whether to grant EUL to Covaxin,” the global health body tweeted, after the Hyderabad-based company made a presentation of the safety and efficacy data on its vaccine to the strategic advisory group of experts on immunization (SAGE), an expert body that advises the WHO.

The WHO said Bharat Biotech has been submitting data to it on a rolling basis and provided additional information at its request on September 27.

“WHO experts are currently reviewing this information and if it addresses all questions raised, WHO assessment will be finalised next week,” it said. In a meeting held on Tuesday, the company made a presentation of clinical data from Covaxin’s phase 1, 2, 3 and post-marketing studies on safety, immunogenicity, efficacy and effectiveness to the SAGE.

“The company has shared about the wide acceptability of the vaccine. It also informed the experts that the vaccine has been approved in 14 countries and over 70 million doses have been sent to overseas markets,” a person in the know told ET.

The details of ongoing and planned studies on safety and effectiveness have also been submitted to the expert body, the person said.

  • Related Posts

    • Pharma
    • March 27, 2024
    • 105 views
    Spurious drugs: Maiden Pharma blacklisted, all contracts cancelled

    Haryana has blacklisted Maiden Pharmaceuticals Ltd, based at Sonepat, for three years, thereby debarring the firm from participating in state tenders. All rate contracts issued to the firm have also…

    • Pharma
    • March 27, 2024
    • 70 views
    DCC Calls For Strict Implementation Of Revised Schedule M, State-Level Activities To Address AMR

    New Delhi: The Drugs Consultative Committee (DCC), the advisory committee formed by the Central government to advise the Central and state governments on matters that require uniform implementation of drug laws…

    Leave a Reply

    Your email address will not be published. Required fields are marked *

    You Missed

    Spurious drugs: Maiden Pharma blacklisted, all contracts cancelled

    Spurious drugs: Maiden Pharma blacklisted, all contracts cancelled

    DCC Calls For Strict Implementation Of Revised Schedule M, State-Level Activities To Address AMR

    DCC Calls For Strict Implementation Of Revised Schedule M, State-Level Activities To Address AMR

    Sanofi, Cipla Join Hands To Expand Reach Of CNS Portfolio In India

    Sanofi, Cipla Join Hands To Expand Reach Of CNS Portfolio In India

    Cyberabad Police Seize 1 Kg Alprazolam, Arrest Three

    Cyberabad Police Seize 1 Kg Alprazolam, Arrest Three

    Lee Health develops natural capsule for effective Heart care

    Lee Health develops natural capsule for effective Heart care

    Medical Shop Run By Twenty20 In Kizhakkambalam Asked To Shut Down

    Medical Shop Run By Twenty20 In Kizhakkambalam Asked To Shut Down