International
With a focus on globalization, Bharat Biotech files for emergency use approval in the Philippines
As part of the globalization of the COVID-19 vaccine developed in India, Bharat Biotech of India has applied for “Emergency Use Authorization” (EUA) in the Philippines. The EUA was introduced in the country earlier this month and is the first international regulatory introduction for Bharat Biotech Covax. Once approved by the local regulator, India is then expected to donate several doses and also open the door to export in commercial terms, as is currently being done by Western and Chinese vaccine manufacturers.
India’s envoy to the Philippines Shambhu Kumaran in a tweet said, “A moment of pride for Indian R&D! First international regulatory introduction for COVAXIN. Satisfied in the Philippines, a vital Indo-Pacific partner. today we celebrate those who made this important moment possible! “
A moment of pride for # Indian R&D! First international regulatory introduction for COVAXIN. Glad to be in # Philippines, a vital Indo-Pacific partner. The process ahead will be challenging, but today we celebrate those who made this important moment possible! BharatBiotech @ICMRDELHI https://t.co/CNuclsSMJN
– Shambhu Kumaran (@shambhukumaran) January 21, 2021
Local drug regulatory authorities are seeking more clinical data from Phase 3 trials and efficacy data. Covaxin Phase III human clinical trials began in mid-November. The development is seen as a major step when it comes to vaccine exports to India and an incentive for Atmanirbhar Bharat (Self-reliance).
The EUA was applied as part of the “pro-active” action and as soon as the data comes in, an immediate approval may come. A delay in such action also means impact on trade agreements in a highly competitive COVID vaccine market. Interestingly, the Philippines already had an agreement with Novavax for COVID vaccines to supply 30 million commercial doses.
While India has so far exported vaccines made in India, the new frontier is seen when the export of vaccines developed in India becomes the norm. Meanwhile, Philippine Foreign Secretary Teodoro Locsin Jr. has praised India’s vaccine diplomacy and, in a tweet, said, “We are asking India to teach us. We are certainly not looking from the West. But we have to look somewhere. next to teach us how to do it “
We are looking to India to teach us. Certainly not looking to the West. But we have to look elsewhere to learn how to do it. https://t.co/yXLT3kOruk
– Teddy Locsin Jr (@teddyboylocsin) January 29, 2021
New Delhi has donated the Covishield vaccine made in India to Oxford-AstraZeneca made by the Serum Institute of India in 10 countries. These are Bhutan, Maldives, Nepal, Bangladesh, Burma, Seychelles, Mauritius, Sri Lanka, Bahrain, Oman.
On Friday, Bangladeshi Foreign Minister Masud Bin Momen, speaking to WION, said Bharat Biotech had offered its vaccines to the country. Bangladesh is eager to co-produce vaccines with India. Brazilian companies have also signed an agreement to supply Covaxin from India. Supplies in the private market will be based on obtaining market authorization from ANVISA, the Brazilian regulatory authority.
India produces 60% of global vaccines and amid the pandemic reaffirmed its position as the “Pharmacy of the World” by supplying HCQ and Paracetamol to 150 countries.
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