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Breaking: DCGI approves Phase II/III clinical trial of COVAXIN in the age group of 2 to 18 Years

by Medically Speaking Team
written by Medically Speaking Team

The National Regulator of the country, the Drugs Controller General of India (DCGI), after careful examination, has accepted the recommendation of Subject Expert Committee (SEC) and accorded permission to conduct the Phase II/III clinical trial of Covaxin (COVID vaccine) in the age group 2 to 18 years, to its manufacturer Bharat Biotech Ltd on 12.05.2021.
M/s Bharat Biotech International Ltd., Hyderabad (BBIL) had proposed to carry out a Phase- II/III clinical trial of Covaxin in the age group of 2 to 18 years. The trial will be conducted in 525 healthy volunteers.
In the trial, the vaccine will be given by intramuscular route in two doses at day 0 and day 28.
As rapid regulatory response, the proposal was deliberated in Subject Expert Committee (SEC) (COVID-19) on 11.05.2021. The Committee after detailed deliberation recommended for grant of permission to conduct proposed Phase II/III clinical trial to certain conditions.

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Direct Supply of Bharat Biotech’s Covaxin commenced in 14 states

by Medically Speaking Team
written by Medically Speaking Team

A direct supply of Bharat Biotech’s Covaxin has been commenced to 14 states with effect from May 1, said Suchitra Ella, company’s Joint Managing Director.

The Hyderabad-based firm has started supplying its Covid-19 treatment vaccine to the states based on the allocations received by the central government.

“Bharat Biotech confirms direct supplies of COVAXIN to the following state govt’s since 1/5/21, based on the allocations received by GoI. Requests have been received from other states, & will be processed for distribution based on availability of stocks 24×7,” Ella tweeted.

The company is supplying vaccines to Andhra Pradesh, Assam, Chhattisgarh, Gujarat, Jammu & Kashmir, Jharkhand, Madhya Pradesh, Odisha, Tamil Nadu, Telangana, Uttar Pradesh, Delhi, Maharashtra and West Bengal.

On April 29, Bharat Biotech announced a cut in the price of ‘Covaxin’ for states to ₹400 per dose from the earlier ₹600 per dose.

This followed widespread criticism of its pricing policy as it sold Covaxin to the central government at ₹150 per dose.

India has announced expansion of its Covid-19 vaccination drive by allowing its large 18-plus population to get inoculated from May 1.

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Price of Bharat Biotech’s Covaxin reduced to Rs. 400 for state govt

by Medically Speaking Team
written by Medically Speaking Team

In a recent announcement made by Bharat Biotech, the price of its Covid-19 vaccine, Covaxin has been reduced from Rs. 600 to Rs. 400 for state governments.

The cost for private hospitals remains Rs. 1200 per dose.

In a statement, the company said, “Bharat Biotech is deeply concerned with the critical pandemic circumstances that India is facing at this time. Recognising the enormous challenges to the public health care system, we have made Covaxin available to state governments at a price of ₹ 400 per dose.”

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Covishield and Covaxin show efficacy against Double Mutant: Study

by Medically Speaking Team
written by Medically Speaking Team

India’s two Covid-19 vaccines, Covishield and Covaxin have shown efficacy against the Indian strain and have show milder infection after the inoculation, a senior scientist said on Tuesday.

Institute of Genomics and Integrative Biology (IGIB) Director, Anurag Aggarwal said that the study on efficacy of the available vaccines on the B.1.617 variant of Covid-19, also known as the “Double Mutant”, shows that post-inoculation, the infection seems milder.

Agrawal tweeted, “Initial positive neutralization studies of B.1.617, with both post-Covaxin or Covishield sera, are correlatable with milder disease during post-vaccination breakthrough infections. This is a positive while we get quantitative data for better understanding of infection protection.”

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Bharat Biotech announces Rate of Covaxin at Rs. 600 to state hospitals and Rs. 1200 to pvt hospitals

by Medically Speaking Team
written by Medically Speaking Team

After Serum Institute, Bharat Biotech has announced that it will sell its Covid-19 vaccine, Covaxin at Rs. 600 to state hospitals and at Rs. 1,200 to private hospitals. The company said that it will export the vaccine at $15-20 per dose.

“Bharat Biotech is honoured to develop, manufacture and supply Covaxin for India’s vaccine rollout at Rs 150 per dose, which is distributed for free by the Government of India. We would like to state that more than 50% of our capacities have been reserved for central government supplies,” it added.

Managing Director and Chairman of Bharat Biotech, Krishna Ella said, “Recovering costs is essential in the journey of innovation towards other vaccines such as intranasal COVID-19, chikungunya, zika, cholera and others. Our core mission for the last 25 years has been to provide affordable yet world class healthcare solutions for the globe.”

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SII and Bharat Biotech granted Rs. 45.67 billion to boost vaccine production

by Medically Speaking Team
written by Medically Speaking Team

India’s government has granted Rs. 45.67 billion to Serum Institute of India (SII) and Bharat Biotech to boost production of Covid-19 vaccines amid quick spreading infections, said Finance Minister Nirmala Sitharaman.

Serum Institute of India has been approved Rs. 30 billion while Bharat Biotech has been granted Rs. 15 billion and the reports say that the payment will be released at the earliest.

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COVAXIN vaccine doses production will be increase to 6-7 fold by July

by Medically Speaking Team
written by Medically Speaking Team

Under Atmanirbhar Bharat 3.0 Mission COVID Suraksha was announced by the Government of India, to accelerate the development and production of Indigenous COVID Vaccines. This is being implemented by Department of Biotechnology Govt of India. According to the Ministry of Science and Technology , the Department of Biotechnology will provide financial support in manufacturing,” Department of Biotechnology is providing financial support as Grant to vaccine manufacturing facilities for enhanced production capacities. Current production capacity of indigenously developed Covaxin vaccine will be doubled by May-June 2021,”

It’s expected that the production will be increased more till month of July, “Nearly 6-7 fold by July – August 2021 i.e increasing the production from 1 crore vaccine doses in April, 2021 to 6-7 crore vaccine dose/month in July – August. It’s expected to reach nearly 10 crore doses per month by Sep 2021,”

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Centre approves Haffkin Institute to produce Covaxin on transfer of technology basis

by Medically Speaking Team
written by Medically Speaking Team

Mumbai-based Haffkin Institute has received permission from the Centre on Thursday to manufacture Bharat Biotech’s Covaxin on the basis of transfer of technology.

The owner of the institute, the Maharashtra government thanked PM Modi for the approval and tweeted, “The Dept. Of Science and Technology, Government of India, has granted approval to Haffkin Institute to produce Bharat Biotech’s CovaxinCovaxin vaccine on a transfer of technology basis.”

“CM Uddhav Balasaheb Thackeray has thanked Prime Minister for approving this request,” the tweet from the CM Office added.

Maharashtra is currently among the highest Covid case spike states.

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320 doses of COVAXIN missing from cold storage of Hari Bux Kanwatia Govt hospital, Jaipur

by Medically Speaking Team
written by Medically Speaking Team

320 doses of Covaxin, a Covid-19 vaccine manufactured by Bharat Biotech, have gone missing from cold storage of Hari Bux Kanwatia Government hospital, Jaipur, Rajasthan.

An FIR has been lodged for the same and the Nodal Officer of the vaccination centre told news agency ANI, “There’s systematic record of doses coming at centre. So it’s suspected that vaccines went missing from store.”

In a later development, Police Station Incharge further stated, “We received report from the hospital that 320 doses of COVAXIN are missing from there. We have registered an FIR with charges of theft. Investigation is underway, CCTV footage will be checked. Action will be taken if any hospital staff is found involved.”

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