Pfizer’s EUA stays as FDA awaits report on Norway deaths — DOH

By: Cathrine Gonzales - Reporter / @cgonzalesINQ - Inquirer.net | January 18,2021 - 05:09 PM

MANILA, Philippines — The emergency use authorization (EUA) for Pfizer’s Covid-19 vaccine will remain for now despite reports that some elderly people with underlying health conditions in Norway have died after getting inoculated with vaccine from the US-based pharmaceutical giant.

In an online press briefing on Monday, Health Undersecretary Maria Rosario Vergeire said the Food and Drug Administration (FDA) is awaiting Pfizer’s report regarding the deaths in Norway.

“Ang sabi ng ating Food and Drug Administration, with this kind of occurrences, pinag-aaralan ‘yan and Pfizer has to submit to the Philippine FDA a report regarding this matter. Once we evaluate their report and base doon sa kanilang conclusion, that is the time that the FDA can decide on the EUA of Pfizer here in the country,” she said.

(The FDA said that with this kind of occurrence, this will have to be studied and Pfizer has to submit a report regarding this matter. Once we have evaluated their report and they have come up with a conclusion, that is time that the FDA can decide on the EUA of Pfizer in the country.)

“For now, hanggang wala pang malaking sufficient evidence to say na talagang ‘yan ay caused by the vaccine tayo po ay status quo pa rin sa ating binigay na EUA ng Pfizer,” she added.

(For now, as long as there is no sufficient evidence to say that the deaths are caused by the vaccine, the EUA of Pfizer remains under the status quo.)

Vergeire noted that Norwegian authorities have reported that those who died were critically ill and that the deaths could be merely coincidental to receiving the vaccines.

“But still they are not closing the issue. They would want to look into it further pero sa ngayon sinasabi nila (but for now, they are saying) they don’t think it is related,” she said.

The country’s FDA granted on January 14 a EUA for Pfizer, noting that interim data from phase 3 trials show that its Covid-19 vaccine has an efficacy of 95 percent in the study population and at least 92 percent among all racial groups.

EDV

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TAGS: critically ill, deaths, elderly, EUA, FDA, Food and Drug Administration, Norway, Pfizer, Vergeire

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