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FDA: Applications for full COVID-19 vaccine registration possible in late 2021
The Food and Drug Administration (FDA) chief expects applications for the commercial distribution of COVID-19 vaccines in the Philippines by late 2021 or early 2022.
To obtain a Certificate of Product Registration (CPR) for commercial sale, vaccine developers must first complete their Phase 3 trials and meet required endpoints for safety and efficacy.
The FDA has granted Emergency Use Authorization (EUA) to seven vaccine manufacturers: Pfizer-BioNTech, Oxford-AstraZeneca, Gamaleya Institute, Sinovac Biotech, Johnson & Johnson, Bharat Biotech, and Moderna.
A CPR allows a product to be commercially available in the market, whereas the current use of COVID-19 vaccines is under EUA.
Additionally, the FDA had previously issued a Compassionate Special Permit (CSP) for the Sinopharm COVID-19 vaccine for President Rodrigo Duterte's close-in security personnel.
The Philippines has so far inoculated 1,744,649 of its 110-million population.
Due to India's decision to prioritize its own population, the Philippines may lower its 2021 vaccination goal to cover only half of the population.
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The Philippines' Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to Moderna's COVID-19 vaccine, making it the seventh vaccine to receive EUA in the country.
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The Philippines received its first shipment of 193,050 Pfizer-BioNTech COVID-19 vaccine doses on Monday, May 10, via DHL Express flight LD457, supplied by the COVAX global facility.
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The Philippines received over 2 million doses of the AstraZeneca COVID-19 vaccine on Saturday, May 8, marking the largest tranche from the COVAX Facility.
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Health Secretary Francisco Duque III has ordered the Department of Health (DOH) to file an emergency use authorization (EUA) application with the Food and Drug Administration for Sinopharm's COVID-19 vaccine.
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The Philippines awaits the submission of regulatory requirements from Indian manufacturer Bharat Biotech before the delivery of its COVID-19 vaccine, Covaxin.
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