Connect with us

Hi, what are you looking for?

[t4b-ticker]
Home » India » Bharat Biotech, Serum Institute Asked To Submit More Data For Full Market Approval To Covaxin And Covishield

India

Bharat Biotech, Serum Institute Asked To Submit More Data For Full Market Approval To Covaxin And Covishield

The Serum Institute of India had applied for market approval for the Covishield in December 2021 and Bharat Biotech has also applied for the same 10 days ago.

Bharat Biotech's Covaxin and SII's Covishield are awaiting full market approval.

New Delhi: The Drugs Controller General of India’s (DCGI) Subject Expert Committee (SEC) will continue thorough review of data submitted by the Serum Institute of India (SII) and Bharat Biotech for granting full market approval to Covaxin and Covishield, sources told ANI.

The SEC has also asked both the companies to submit more data before granting full market approval. Another SEC meeting is expected next week. The Serum Institute of India had applied for market approval for the Covishield in December 2021 and Bharat Biotech has also applied for the same 10 days ago.

The market authorisation for vaccine means that it can be authorised for use without reservation and conditions.

ALSO READ: Mistakes Of 2021 Being Repeated: Doctors Write To Govt, Warn Against Unnecessary Medication And Tests

Further, Bharat Biotech has said that Covaxin is now a universal vaccine for adults and children. However, both Covaxin and Covishield are currently authorised for emergency use only. The subject expert committee of the Central Drugs Standard Control Organisation (CDSCO) met on January 1 and January 2, 2021 and made recommendations in respect of the proposal for restricted emergency approval of Covid-19 virus vaccines of Serum Institute of India and Bharat Biotech.

The SEC consists of domain knowledge experts from the fields of pulmonology, immunology, microbiology, pharmacology, paediatrics, internal medicine etc. It had reviewed the data on the safety and immunogenicity of the vaccine and recommended grant of permission for restricted use in an emergency situation in the public interest as an abundant precaution in clinical trial mode to have more options for vaccination especially in case of infection by mutant strains.

The clinical trial ongoing within the country by the firm will continue. The Serum Institute of India and Bharat Biotech vaccines have to be administered in two doses and all the vaccines have to stored at 2-8 degrees Celsius.

Read Full Article

Spotlight

Politics

The Congress in Punjab is yet to decide on who will be its face in the Assembly elections. Chief Minister Charanjit Singh Channi and...

Sports

Lakshya Sen from Almora won against Singaporean world champion Loh Kean Yew in a thrilling final 24-22, 21-17. He became the first Indian to...

India

Due to COVID-19 restrictions, the number of visitors to be substantially curtailed this year. We are looking at a range of 5000 to 8000...

World

The team led by researchers at the University of Exeter found that 13 per cent of people still exhibited clinically-relevant levels of virus after...

Videos

Dhanush in his shared statement, apart from revealing the shocking news also asked people to respect their decision and give them the needed privacy...

You May Also Like

Politics

A Lok Sabha MP since 2014, Mann is a popular face in Punjab and is one of the indisputable comedy kings. Mann has also...

Videos

Dhanush in his shared statement, apart from revealing the shocking news also asked people to respect their decision and give them the needed privacy...

Sports

Bharath Subramaniyam from Tamil Nadu became the 73rd Chess Grandmaster of India. He achieved the third and final Grandmaster Criterion at an event in...

India

Prime Minister Modi also highlighted India's role in providing vaccines to the world.

Advertisement