EUA on Pfizer vaccine won’t be revoked yet despite Norway deaths, DOH says

MANILA, Philippines — The emergency use authorization (EUA) issued last week by the Food and Drug Administration (FDA) to drug-maker Pfizer-BioNTech for its COVID-19 vaccine will not be revoked yet pending an investigation into claims that it caused the death of some elderly people in Norway, the Department of Health (DOH) said Monday.
Health Undersecretary Maria Rosario Vergeire said Norwegian authorities are still looking into reports that 23 individuals aged 75 to 80 with underlying health conditions died after getting inoculated with COVID-19 vaccine developed by Pfizer-BioNTech.
Vergeire also said that studies need to be done on the matter.
“Pfizer has to submit a report to the Philippine Food And Drug Administration regarding this matter. Once we evaluate the report, base sa kanilang conclusion, that’s the time FDA can decide on the EUA of Pfizer. For now,” Vergeire said.
“Hanggang wala pang sufficient evidence that it was caused by vaccines, status quo tayo on this EUA given to Pfizer,” she added.
The FDA granted EUA to Pfizer last January 14, the first out of four applications it received so far. Other applications are AstraZeneca, China’s Sinovac, and Russia’s Gamaleya Institute.
FDA Director-General Eric Domingo said they are still awaiting a report from Norwegian authorities and that they will “revise the conditions of the EUA as needed,” before starting vaccinations as part of the agency’s protocols on the use of vaccines.
Health authorities also reiterated that COVID-19 vaccines will go through stringent evaluation before it can be approved for use in the country.
“Aside from the safety, and the efficacy na meron ang mga bakuna na papasok, titingnan din nila iyon pong social impact nito, titingnan nila ang affordability and titingnan nila sa response ng equity,” Vergeire said.
“They will be evaluating and then they give their recommendation to the Secretary. Kapag positive ang recommendation, we can procure the specific vaccine,” she added. – RRD (with details from Correspondent Aiko Miguel)