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Home / News / India News / Indian government could approve Oxford-AstraZeneca's coronavirus vaccine by next week
  • India

    Indian government could approve Oxford-AstraZeneca's coronavirus vaccine by next week

    Shalini Ojha
    Written by
    Shalini Ojha
    Twitter
    Last updated on Dec 23, 2020, 11:51 pm
    Indian government could approve Oxford-AstraZeneca's coronavirus vaccine by next week
  • The coronavirus vaccine, developed by the University of Oxford and AstraZeneca, is likely to get approval from the Indian government for emergency use by next week, two people privy to the development told Reuters.

    Serum Institute of India (SII), which is producing mass doses of the vaccine dubbed Covishield here, submitted the additional information sought by the government, the news agency added.

    Here's more.

  • In this article
    All companies were asked to submit more data; SII did India could become the first country to approve this vaccine How efficient is the vaccine? India is considering two-dose regimen of the vaccine Approval by UK was thought to be crucial for India UK could give green-signal before 2021
  • Series of events

    All companies were asked to submit more data; SII did

    All companies were asked to submit more data; SII did
  • On December 9, the Central Drugs Standard Control Organisation (CDSCO) reviewed the applications and asked for more information from all three companies — SII, Pfizer, and Bharat Biotech. The other two organizations have also sought emergency use authorization.

    SII has submitted the details. A government official said on Tuesday that they were still waiting for Pfizer's additional data.

    Bharat Biotech's response is also awaited.

  • Details

    India could become the first country to approve this vaccine

    India could become the first country to approve this vaccine
  • Both sources told Reuters the Indian authorities were speaking with their British counterparts about the vaccine and there were "strong indications" that the vaccine will get approval next week.

    If India gives the green signal, it could become the first nation to approve Oxford-AstraZeneca's vaccine.

    This particular vaccine is considered the best option for lower-income countries as it's cheap and can be stored/transported easily.

  • Safety

    How efficient is the vaccine?

  • Earlier this month, final-stage clinical trial data was published in The Lancet. The vaccine was found to be 62% effective when both doses were administered, and the efficacy increased to 90% when half a dose was given.

    "ChAdOx1 nCoV-19 (the vaccine) has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials."

  • Consideration

    India is considering two-dose regimen of the vaccine

  • Notably, Indian authorities are considering the two full-dose regimen, even if it was found to be less effective.

    A report in IE also said SII has given data.

    "Serum Institute of India has submitted additional data. The regulator's office, internally, will review these documents. Only then they will request the Subject Expert Committee (SEC) to meet," sources told the daily.

  • Connection

    Approval by UK was thought to be crucial for India

  • It should be noted that the approval for the vaccine in India was thought to be dependent on the UK's action.

    During the December meeting, an expert panel had directed SII to submit the conclusions of the British regulator.

    But the current request submitted by SII finds its roots in data of the clinical trials conducted in Brazil and the UK.

  • UK's nod

    UK could give green-signal before 2021

    UK could give green-signal before 2021
  • Meanwhile, authorities in the UK stated they were reviewing the vaccine, while adding that it won't be approved until it meets the standards of safety, quality, and efficacy.

    "Any vaccine must undergo robust clinical trials in line with international standards, with oversight provided by the Medicines And Healthcare Products Regulatory Agency," a spokesperson said.

    The Daily Telegraph claimed the approval in UK could come by December 28-29.

  • India
  • Pfizer
  • Reuters
  • University of Oxford
  • Lancet
  •  
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