EMERGENCY USE NG COVAXIN, JANSSEN VACCINES APRUBADO NA — FDA

Ni Raiza F. Cabugwang
Photo courtesy of pna.gov.ph
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Kinumpirma ni Food and Drug Administration (FDA) Director General Eric Domingo noong Lunes, Abril 19, 2021, na binigyan na ng emergency use authorization (EUA) ng kanyang ahensya ang Covaxin at Janssen COVID-19 vaccines. 

Ikinatuwa naman ang balitang ito ng India’s Ambassador to the Philippines na si Shambhu Kumaran. 

“Delighted that #Covaxin has been granted EUA in the #Philippines. Congratulations @BharatBiotech! Thank you @FDAPhilippines,” saad ni Ambassador Kumaran sa kanyang Twitter account.

Ayon kay Kumaran, nasa 81 porsyento ang bisa ng nasabing bakuna base sa isinagawang large-scale clinical trials dito na nilahukan ng 25,000 katao.

Ang Covaxin ay isang inactivated virus-based na bakuna na gumagamit ng patay nang uri ng severe acute respiratory syndrome coronavirus 2 o SARS-CoV-2, ang virus na nagdudulot ng COVID-19. Ito ay isa sa pinakaluma at pinakasubok na paraan upang makabuo ng antibody response ang isang bakuna.

Ayon pa sa Ambassador, handa aniya ang India na magsuplay ng paunang batch ng Covaxin na aabot sa walong milyong doses.

Ang Covaxin ay binuo ng biotechnology company na Bharat Biotech at ng Indian Council of Medical Research na nasa ilalim naman ng pamahalaan ng India.

Samantala, sinabi naman ni Director General Domingo na inaasahan na niya na mabibigyan ng EUA ang Janssen vaccine.

Ang Janssen, na isang single-dose COVID-19 vaccine, ay binuo ng American drugmaker na Johnson & Johnson. Ang naturang kumpanya ay nagsumite ng kanilang aplikasyon para sa EUA ng kanilang bakuna noong Marso 31 ng taong ito.

Pinasalamatan naman ni Vaccine Czar Carlito Galvez, Jr. ang FDA hinggil sa pag-apruba ng nasabing EUA 

“‘Yong Johnson & Johnson, nagpapasalamat po tayo sa FDA kasi lumabas na po ‘yong kanyang EUA,” ani Galvez.

Bukod sa Covaxin at Janssen, inaprubahan na rin ng FDA ang aplikasyon ng EUA para sa Pfizer-BioNTech, Oxford-AstraZeneca, Sinovac, at Gamaleya-Sputnik V vaccines.

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