Bharat Biotech to submit additional data for vaccine s emergency approval(IANS Special)
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Aakanksha Khajuria ( IANS) |
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Wed, Dec 23 2020 18:33 IST |
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Bharat Biotech recruits 13,000 volunteers for Phase III trials of Covaxin. Image Source: IANS News
New Delhi, Dec 23 : Hyderabad-based Bharat Biotech, which is developing the country s indigenous coronavirus vaccine in collaboration with the Indian Council of Medical Research (ICMR), will submit the additional data sought by the Drug Controller General of India (DCGI) for grant of emergency use authorisation to its vaccine in a week or two .
COVAXIN, an inactivated vaccine candidate, is currently undergoing Phase III human clinical trials on 26,000 volunteers at 25 centres across India, after having undergone Phase I and II trials involving 1,000 volunteers.
Serum Institute submits fresh data for Covishield emergency approval
“Serum Institute 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 Indian Express. Updated: December 23, 2020 7:34:35 am
At the Pune-based Serum Institute of India, which has collaborated with Oxford University and pharmaceutical major Astra Zeneca for the production of one of the five vaccine candidates in India. (Reuters)
Just two weeks after the expert committee scrutinising applications for
emergency use authorisation (EUA) of Pune-based Serum Institute of India’s Covid-19 vaccine sought additional late-stage safety and efficacy data, the firm has submitted fresh data to the regulator, government sources said.
Covid vaccine-maker submits more data to expert panel
December 22, 2020
Dr VK Paul, Member, NITI Aayog - Shanker Chakravarty×
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One of the vaccine manufacturers that had applied for accelerated approval for Covid vaccine candidates has submitted more data as demanded by the Subject Expert Committee (SEC) attached to the Drug Controller General of India (DCGI). Disclosing this, Vinod K Paul, Member (Health) NITI Aayog, on Tuesday said that experts are studying the data.
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Paul, however, did not share the developer’s name. Though three firms had submitted their applications for accelerated approval of their vaccines, the US firm Pfizer, which jointly with German firm BioNTech developed the mRNA vaccine, has not yet submitted the data to SEC.
Covid-19 vaccination to begin next month: Harsh Vardhan
Hyderabad-based Bharat Biotech has claimed that amongst all the vaccine platforms such as an mRNA-based vaccine, DNA-based vaccine, vector-based vaccine, or live attenuated vaccines, the inactivated vaccines being developed by it for Covid 19 are safest with lesser adverse reactions
PM Narendra Modi reviewed the development of COVID-19 vaccine candidate ZyCOV-D in Ahmedabad.
Union health minister Harsh Vardhan said vaccination of Covid-19 may begin in January 2021 and the government is taking all precautions to ensure the safety and efficacy of the vaccine, without naming which vaccine will be given first. I personally feel may be in January in any stage or any week, there can be a time when we can be in a position to give first Covid vaccine shot to people of India Harsh Vardhan told ANI, when asked about India s vaccination drive against the coronavirus.
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New Delhi: The review of Oxford University’s Covid-19 vaccine candidate is “ongoing”, said the UK’s top drug regulatory agency Monday.
The UK became the first country to approve and roll out Pfizer’s Covid-19 vaccines. It has already begun the first Covid-19 vaccination programme in the world, with vaccine shots of the Pfizer/BioNTech product being given to elderly people and healthcare workers.
Now, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is reportedly planning to approve Oxford University-AstraZeneca’s vaccine before the end of this year.
The move is likely to boost the vaccine candidate’s chances of getting the necessary approvals in India.