India's COVAXIN vaccine gets authorisation in 13 nations; working on EUAs in 60 more + WHO

While India continues to expedite COVID-19 vaccine production with an aim to provide on-demand jabs by August this year, Bharat Biotech's COVAXIN has made a massive leap into the global market as it announced that it has obtained the Emergency Use Authorization (EUA) in 13 countries with more to follow. The EUA obtained in 13 countries means that COVAXIN could soon begin circulation in these countries. The Hyderabad-based pharma company on Tuesday has said that regulatory approval for its COVID-19 vaccine, developed in partnership with the ICMR, is under process in over 60 countries overall including the USA, Brazil and Hungary among others. 

Notably, Bharat Biotech has also submitted an application for EUL to the World Health Organization (WHO), in a bid to ease EUAs in several other countries. It expects WHO's regulatory approvals by July-September this year. COVAXIN, which has also proved to be effective against the B.1.617 strain and other mutations of the virus, is said to have an efficacy rate of 81% which preliminary data from its phase 3 trials have shown. The vaccine is currently in circulation only in India. 

Key highlights of COVAXIN's major leap: 

• Regulatory approvals for COVAXIN in process in over 60 countries including USA, Brazil and Hungary 

• EUA for COVAXIN obtained in 13 countries so far

• Application for EUL submitted to WHO-Geneva. Regulatory approvals expected by July-September 2021

Bharat Biotech eyes US trials

Bharat Biotech on Monday had stated that the company is also in advanced negotiations with the US FDA (Food and Drug Administration) for commencing small-scale phase-III clinical trials of their COVID-19 vaccine in the United States, and is seeking EUA in America with the help of its partner Ocugen. As per sources, for seeking the World Health Organisation (WHO) approval, Bharat Biotech has also submitted 90 per cent of documents to the global body for obtaining emergency use listing for their Coronavirus vaccine.  

Covaxin reaches 30 cities

As the vaccination drive across the country continues, Bharat Biotech's Covaxin has reached 30 cities in 30 days, the Indian pharma giant announced on Tuesday. Bharat Biotech Co-founder and Joint Managing Director Suchitra Ella took to Twitter and announced that the company's COVID-19 vaccine has reached 30 cities within a month. As per Ella's tweet, the doses have been dispatched to private hospitals in these cities.

Additionally, Suchitra Ella also announced that the pharma major's employees are committed and working round the clock to ensure the country's immunisation. She further informed that some employees are still quarantined and off-work owing to the prevailing Coronavirus situation in India. Among some of the cities that have received the COVAXIN doses include Amritsar, Bengaluru, Chennai, Delhi, Kochi, Kolkata and Mumbai among several others. 

Bharat Biotech ramps up production in India 

In addition to the existing Hyderabad plant and the Bengaluru plant in process, Bharat Biotech last week announced the setting up of an additional manufacturing unit of COVAXIN in Gujarat to boost the production of its COVID-19 vaccines. The Hyderabad-based pharma firm informed that COVAXIN will now be manufactured by Chiron Behring Vaccines, Ankleshwar, Gujarat, a wholly-owned subsidiary of Bharat Biotech. It has set an aim to produce 200 million doses of COVAXIN within a year, with the vaccine availability at the Ankleshwar facility to commence from the fourth Quarter of 2021. With the addition of a manufacturing plant in Gujarat, Bharat Biotech has now ramped up the production of COVAXIN to 1 billion doses per annum, in its own established campuses. 

COVAXIN manufacturing locations in India now: 

• Bharat Biotech plant at Hyderabad
• Bharat Biotech plant at Bengaluru
• Bharat Biotech plant at Ankleshwar, Gujarat
• Haffkine Biopharma Corporation, Mumbai
• IIL Hyderabad
• BIBCOL, Bulandshahr