Published April 9, 2021, 4:25 PM
Food and Drug Administration (FDA) Director General Eric Domingo said the product label for the AstraZeneca vaccine will be updated to include information about the “very rare” possibility of blood clots among people who will be immunized against the coronavirus disease (COVID-19). (Photo by Fred TANNEAU / AFP / FILE PHOTO)
In a media forum on Friday, April 9, Domingo said the FDA had a meeting with AstraZeneca on April 7 informing them about the product label update that will mention a “very rare side effect or very rare adverse event of blood clotting associated with thrombocytopenia or decreased platelet count.”
(JANSEN ROMERO / FILE PHOTO / MANILA BULLETIN)
“Hindi naman namin bibigyan ng CSP [compassionate special permit] kung hindi eligible [yung hospital]. (We will not issue a CSP if the hospital is not eligible,” Domingo said in a Department of Health briefing on Friday, April 9.
“Kaya po sya nabigyan ng CSP dahil nag apply po yung isang ospital at nasubmit naman niya lahat ng requirements na kinakailangan. (That’s why it was given a CSP because the hospital applied and it submitted all the requirements),” he added.
Domingo explained that a doctor or hospital can request for a compassionate special permit (CSP) if a drug is not available in the Philippines but is registered and available in another country, or that a drug is undergoing clinical trial as a treatment for certain illnesses, such as coronavirus disease (COVID-19).
FDA Director General Eric Domingo
(RTVM / FILE PHOTO)
Domingo made the statement following reports of some people calling for him to step down due to alleged irregularities and questionable decisions of the FDA.
“Well, ako naman po sumusunod lang ako sa mga proseso ng FDA. Siguro po may mga iba hindi sila natutuwa sa ating mga desisyon pero based naman po tayo on processes at saka scientific evidence (Well, I just follow the FDA processes. Maybe there are others who are not happy with our decisions but we are based on processes and also scientific evidence),” he said in a press briefing.
Philippines FDA OKs Sinovac vaccine for senior citizens amid low AstraZeneca supply By JOAHNA LEI CASILAO, GMA News
Published April 7, 2021 5:43pm
Updated April 7, 2021 7:06pm The Food and Drug Administration (FDA) on Wednesday approved the use of the vaccine developed by Chinese pharmaceutical firm Sinovac amid a shortage in vaccine supply. However, Director-general Eric Domingo said an evaluation of the senior citizen’s health must first take place to ensure that the benefits will outweigh the risks. After considering the recommendation of the experts and the current situation of high covid 19 transmission and limited available vaccines, the FDA is allowing the use of Sinovac on senior citizens,” he said in a statement.
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