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Bharat Biotech applies for emergency use authorization of Covaxin in Philippines
EUA was filed earlier this month in the country and is the first international regulatory filing for Bharat Biotech`s COVAXIN. Once approved by the local regulator, India is expected to donate some doses and also open the door for exports in commercial terms, as is being done currently by Western and Chinese vaccine manufacturers.
Highlights
- The local drug regulatory authorities are looking for more clinical data from Phase 3 trials and efficacy data.
- Philippines foreign secretary Teodoro Locsin Jr has lauded India's vaccine diplomacy.
- India produces 60% of global vaccines and amid the pandemic.
New Delhi: As part of the globalization of India-developed COVID-19 vaccine, India's Bharat Biotech has applied for "Emergency use authorization" (EUA) in the Philippines.
EUA was filed earlier this month in the country and is the first international regulatory filing for Bharat Biotech's COVAXIN. Once approved by the local regulator, India is expected to donate some doses and also open the door for exports in commercial terms, as is being done currently 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! The first international regulatory filing for COVAXIN. Delighted it is in the Philippines, a vital Indo-Pacific partner. Process ahead will be challenging but today we celebrate those who made this key milestone possible!"
The local drug regulatory authorities are looking for more clinical data from Phase 3 trials and efficacy data. Phase 3 human clinical trials of COVAXIN began mid-November. The development is seen as a major step when it comes to India's vaccine exports and a boost to "Atmanirbhar Bharat" (self-reliance).
The EUA was applied as part of "pro-active" action and as soon as the data comes, an immediate approval can come. A delay in such action also means, impact on commercial deals in a very competitive Covid-19 vaccine market. Interestingly, the Philippines already had a deal with Novavax for Covid-19 vaccines for the supply of 30 million doses commercially.
While India has so far exported India-made vaccines, the new frontier is seen when the export of India-developed vaccines becomes the norm.
Meanwhile, Philippines foreign secretary Teodoro Locsin Jr has lauded India's COVID-19 vaccine diplomacy and, in a tweet, said, "we're looking to India to teach us. We're certainly not looking to the West. But we need to look elsewhere to teach us how to get it done"
New Delhi has gifted India-made Covishield vaccine of Oxford-AstraZeneca made by Serum Institute of India to 10 countries. These are Bhutan, Maldives, Nepal, Bangladesh, Myanmar, Seychelles, Mauritius, Sri Lanka, Bahrain and Oman.
On Friday, Bangladesh's Foreign Secretary Ambassador Masud Bin Momen speaking to WION said Bharat Biotech has offered its COVID-19 vaccines to the country. Bangladesh is keen on the co-production of COVID-19 vaccines with India. Brazilian companies have also signed an agreement for the supply of COVAXIN from India. Supplies to the private market would be based upon receipt of market authorization from ANVISA, the Brazilian regulatory authority.
India produces 60% of global vaccines and amid the pandemic reaffirmed the position as the "Pharmacy of the world" by supplying HCQ and Paracetamol to 150 countries.