“After a thorough review of the currently available data by medical and regulatory experts, the FDA is granting Emergency Use Authorization to Pfizer-BioNTech COVID-19 vaccine,” pahayag ni Director General Eric Domingo.
Lumabas aniya sa interim data mula sa nagpapatuloy na phase 3 trial na 95 porsyento ang efficacy rate ng naturang bakuna sa study population at 92 porsyento ng lahat ng racial groups.
“The roll out of the vaccine and use in more than 5 million people worldwide has identified severe allergic reaction in a few individuals. Therefore, the vaccinations must be done by health professionals trained to recognize and manage adverse reactions and they should have resources at hand to adequately respond,” dagdag pa nito.
Sinabi pa ng FDA chief na ang bakuna mula sa American pharmaceutical firm ay kailangan ng storage na may temperatura na -80 hanggang -60 degrees Celsius.
Samantala, nilinaw ni Domingo na ang pagbibigay ng EUA ay hindi isang marketing authorization o Certificate of Product Registration.
Nangako naman ang FDA na patuloy nilang titiyaking magkakaroon ng access ang mga Filipino sa mga bakuna na may mas maraming benepisyo kaysa sa posibleng hindi inaasahang epekto sa gitna ng pandemya.
“We will keep track of the progress and FDA will provide our public with the correct information on the authorized products for transparency, to aid the decision making of Filipinos,” ani Domingo.