Bharat Biotech agrees to give COVAXIN formula to other manufacturers: Centre

Bharat Biotech releases Covaxin Phase-3 trial data, claims 77.8% effective, provides 65.2% protection against Delta variant

Phase-III trials of Covaxin, made by Hyderabad’s Bharat Biotech, the vaccine has been found to be 77.8% effective against symptomatic Covid-19 and it was 93.4% effective against severe symptomatic Covid-19, the firm claimed on Saturday.

The data demonstrated 65.2% protection against SARS-CoV-2 B.1.617.2, known as the Delta variant, first identified in India.

Against asymptomatic Covid-19, Covaxin was found to offer 63.6% protection, as per the efficacy data.

Updates on Covaxin

• Bharat Biotech is conducting clinical trials to establish the safety and efficacy of Covaxin in children between the age of 2 and 18 years.

• A clinical trial to determine the safety and immunogenicity of a booster dose is also underway.

• Several research activities are being carried out to study variants of concern and to assess their suitability for follow-up booster doses, the company said.

• In terms of production, Covaxin is being manufactured by Bharat Biotech at four facilities in India. The company aims to reach an annualised capacity of 1 billion doses by the end of this year.

• Globally, Covaxin has already received emergency use authorisation in 16 countries including Brazil, India, Philippines, Iran and Mexico.

• The company is in talks with the World Health Organisation to obtain emergency use listing for its vaccine.

The National Institute of Virology-ICMR Director has praised Bharat Biotech for developing Covid vaccine — Covaxin. The Hyderabad-based company on Friday announced the safety and efficacy analysis data from phase-3 clinical trials of Covaxin, which is developed in partnership with ICMR and NIV.

Efficacy analysis demonstrated Covaxin to be 77.8 per cent effective against symptomatic Covid and 93.4 per cent effective against severe symptomatic virus.
Speaking on the results, Professor (Dr) Priya Abraham, Director National Institute of Virology ICMR said: “The overall efficacy of 77.8% following the phase III clinical trial of COVAXIN is wonderful news.”

“ICMR-NIV and BBIL (Bharat Biotech) have had very fruitful interactions during this exhilarating journey. Sera from COVAXIN recipients have also been evaluated against viral variants detected in India i.e., the Alpha, Beta, Zeta, Kappa and Delta. The making of this vaccine entirely on Indian soil is a matter of great pride to every Indian,” Abraham said.

Covaxin has now received emergency use authorizations in 16 countries including, Brazil, India, Philippines, Iran, Mexico, etc. with EUA’s in process in 50 countries worldwide. The company is in discussions with WHO to obtain emergency Use Listing for Covaxin. The product has been exported to several countries with additional requests for supplies being received.

Professor (Dr) Balram Bhargava, Secretary Department of Health Research and Director General Indian Council of Medical Research, said that he was delighted to note that Covaxin, developed by ICMR and Bharat Biotech under an effective public private partnership, has demonstrated an overall efficacy of 77.8 per cent in India’s largest phase 3 clinical trial thus far.

“Our scientists at ICMR and BBIL have worked tirelessly to deliver a truly effective vaccine of highest international standards. Covaxin will not only benefit the Indian citizens but would also immensely contribute to protect the global community against the deadly SARS-CoV-2 virus. I am also pleased to see that Covaxin works well against all variant strains of SARS-CoV-2. The successful development of Covaxin has consolidated the position of Indian academia and Industry in the global arena,” he said.

https://www.livemint.com/news/india/great-pride...

What a coincidence, got my covaxin jab today.

Covid-19: Clinical trials under way for Covaxin’s booster dose

Bharat Biotech International Limited has stated that clinical trials to determine the safety and immunogenicity of Covaxin’s booster dose are in process.

The Hyderabad-based vaccine maker announced that its two-dosed Covid-19 vaccine is showing an overall efficiency of 77.8% against Covid-19 and is 93.4% effective in severe infection cases.

“Our commitment to improve Covaxin is well under way with additional clinical trials to establish safety and efficacy in children between 2-18 years of age. A clinical trial to determine the safety and immunogenicity of a booster dose is also in process. Several research activities are being carried out to study variants of concern and to assess their suitability for follow-up booster doses,” Bharat Biotech said, while releasing the final Phase-3 trial results.

Decision on emergency use listing of Covaxin likely in 4-6 weeks: WHO

The World Health Organization (WHO) is likely to take a decision on including Bharat Biotech’s COVID-19 vaccine Covaxin in the emergency use list (EUL) within four to six weeks, Soumya Swaminathan, the global health body’s chief scientist has said.

Speaking at a webinar organised by the Centre for Science and Environment (CSE) on Friday, Swaminathan said the WHO is reviewing Covaxin as its manufacturer Bharat Biotech is now uploading its entire data on the health body’s portal. (PTI)