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"Bharat Biotech announces Covaxin final phase-3 results"

"Bharat Biotech announces Covaxin final phase-3 results"

  • "Hyderabad-based Bharat Biotech has released its data from the final analysis of Covaxin efficacy as part of phase 3 clinical trials.

  • The company said on Friday that the indigenous vaccine demonstrates overall efficacy of 77.8% against symptomatic infection."

Key update:

  • An expert panel of the country's central drugs authority had reviewed and accepted the phase-3 trial data of Bharat Biotech's Covid-19 vaccine Covaxin last month.

About Covaxin:

  • Covaxin is one of the three vaccines approved by the DGCI for emergency use and is being deployed in the Covid-19 vaccination programme.
  • Covaxin is a whole virus inactivated vaccine against SARS-CoV2, developed by Bharat Biotech in partnership with ICMR and NIV Pune.
  • It has received emergency use authorizations in 16 countries including, Brazil, the Philippines, Iran and Mexico.

Important Results of Clinical trial:

  • In what Bharat Biotech called ""India's largest efficacy trial"", over 25,798 participants between 18 and 98 years of age were recruited from 16 November year to 7 January 2021 for phase 3.
  • In addition to the overall efficacy, Covaxin provides 65.2% protection against the B.1.617.2 (Delta) variant, which is currently dominant in India: said Bharat Biotech.
  • It has shown 93.4% efficacy against severe infections.

Future course:

  • Bharat Biotech is in discussions with WHO to obtain an emergency use listing for Covaxin.and now estimates that it will make 23 million doses a month.

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