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No emergency approval for SII, Bharat Biotech's vaccine candidates yet
Last updated on Dec 09, 2020, 07:49 pm
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Two applications submitted by the Pune-based Serum Institute of India and Hyderabad-based Bharat Biotech seeking emergency approval for their respective COVID-19 vaccines have not been cleared, NDTV reported on Wednesday.
The two potential vaccines are notably the leading candidates in India.
On Tuesday, the Health Ministry had assured that emergency approval would be granted within weeks.
Here are more details.
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In this articleGovernment panel seeks more data on vaccines' safety, efficacy Panel reviewed three vaccines' emergency approval request Health Ministry clarifies emergency approval not rejected You can view the Health Ministry's tweet here Covishield undergoing Phase III trials in India; 70% effective Bharat Biotech's COVAXIN also undergoing Phase III trials
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Details
Government panel seeks more data on vaccines' safety, efficacy
![Government panel seeks more data on vaccines' safety, efficacy]( "Government panel seeks more data on vaccines' safety, efficacy")
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The two applications were denied clearance over inadequate safety and efficiency data, sources told NDTV.
The sources reportedly said, "Both proposals are not approved due to inadequate safety and efficiency data available currently. Both have been asked for more data."
Sources in SII added, "It's standard practice for the government to hold several meetings. The process is expected to go on for one-two weeks."
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Review meeting
Panel reviewed three vaccines' emergency approval request
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The Subject Expert Committee of the Central Drugs Standard Control Organization (CDSCO) had reviewed the applications for three COVID-19 vaccine candidates on Wednesday.
The third candidate is Pfizer and BioNTech's BNT162b2, which has not undergone clinical trials in India. However, the vaccine—which has 95% efficacy—has been granted emergency approval in the United Kingdom, where vaccinations have commenced, and Bahrain.
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Information
Health Ministry clarifies emergency approval not rejected
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Earlier, NDTV had reported that the application for emergency approval by the SII and Bharat Biotech had been rejected. However, the official Twitter handle of the Union Health Ministry said the media report was "fake news."
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Twitter Post
You can view the Health Ministry's tweet here
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#FAKENEWS
— Ministry of Health (@MoHFW_INDIA) December 9, 2020
The news running on @ndtvindia is Fake News. pic.twitter.com/VZv7uwW5z7 -
SII
Covishield undergoing Phase III trials in India; 70% effective
![Covishield undergoing Phase III trials in India; 70% effective]( "Covishield undergoing Phase III trials in India; 70% effective")
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Notably, Covishield—which is currently undergoing Phase III trials in India—has been developed at the SII with a master seed from pharma giant AstraZeneca and Oxford University.
AstraZeneca had earlier announced that the vaccine has shown 90% and 62% efficacy in two dosing regimens, reflecting an average efficacy of 70%.
The vaccine's final-stage trial data was peer-reviewed and published in The Lancet on Tuesday.
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Bharat Biotech
Bharat Biotech's COVAXIN also undergoing Phase III trials
![Bharat Biotech's COVAXIN also undergoing Phase III trials]( "Bharat Biotech's COVAXIN also undergoing Phase III trials")
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On the other hand, COVAXIN is being developed by Bharat Biotech in collaboration with India's apex bio-research agency Indian Council of Medical Research (ICMR).
It is a wholly-inactivated novel coronavirus vaccine and is currently undergoing Phase III trials in India.
Earlier in November, an India Today report had quoted officials as saying that the vaccine is expected to be 60% effective.
