India’s Covaxin gets authorisation in 13 countries; pushing for EUAs in 60 more and WHO
28 May 2021
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Bharat Biotech's vaccine against the Wuhan virus, Covaxin, has obtained emergency use authorisation in 13 countries, even as the country is working on expediting vaccine production to meet on-demand jabs by August this year.
Bharat Biotech on Tuesday said that regulatory approval for its new coronavirus vaccine, developed in partnership with the India Council for Medical Research (ICMR), is under the EUA process in over 60 countries, including the USA, Brazil and Hungary among others.
The Hyderabad-based pharma company has also submitted an application for EUL to the World Health Organisation (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 Wuhan virus, is said to have an efficacy rate of 81 per cent, according to preliminary data obtained from phase 3 trials.
Bharat Biotech on Monday said the company is also in advanced negotiations with the US FDA (Food and Drug Administration) for commencing small-scale phase-III clinical trials of Covaxin in the United States. It has partnered with an American company, Ocugen, in this pursuit.
Bharat Biotech has submitted 90 per cent of the documents to the global body for obtaining emergency use listing for their Coronavirus vaccine, reports citing sources said.
In India, Covaxin has reached 30 cities in 30 days, Bharat Biotech’s co-founder and joint managing director Suchitra Ella stated in a Twitter message. As per Ella's tweet, the doses have been dispatched to private hospitals in these cities.
Additionally, she said the company’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 is ramping up vaccine production at its Hyderabad and Bengaluru plants, besides setting up an additional manufacturing unit for Covaxin in Gujarat to boost production.
Covaxin will now also 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.
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