DOH: No reason yet to revoke EUA on Pfizer vax despite Norway deaths

The emergency use authorization issued by the Food and Drug Administration (FDA) to Pfizer-BioNTech's COVID-19 vaccine will remain pending evidence that it caused the deaths of frail, elderly individuals in Norway, Health Undersecretary Maria Rosario Vergeire said Monday.

Vergeire was responding to reports that 23 individuals in Norway aged 75 to 80 and with serious basic disorders had died after receiving COVID-19 vaccine manufactured by Pfizer-BioNTech.

“They (Norway authorities) are still looking into it. They don’t think it is related, pero pinag-aaralan pa nila,” Vergeire said in an online briefing.

“Wala pang sufficient evidence na ‘yan ang cause ng death kaya status quo muna tayo sa EUA na ibinigay ng FDA sa Pfizer-BioNTech,” she added.

The FDA, in granting EUA to Pfizer-BioNTech's vaccine, said the vaccine was found 95% effective among its study population and 92% on all races after evaluation.

Pfizer-BioNTech is the only COVID-19 vaccine which has secured EUA from the Philippine FDA so far. Other pending EUA applications include that of Sinovac, AstraZeneca and Gamaleya. —KBK, GMA News