Pfizer vaccine's EUA in PH stays, but FDA to ask for report on elderly deaths in Norway

Kristine Sabillo, ABS-CBN News

Posted at Jan 18 2021 02:13 PM | Updated as of Jan 18 2021 02:41 PM

Pfizer vaccine's EUA in PH stays, but FDA to ask for report on elderly deaths in Norway 1
A health professional is given an injection of the Pfizer-BioNTech vaccine against COVID-19 at the Refena centre in Pamplona, Spain, January 17, 2021. Vincent West, Reuters/File

MANILA — There won’t be any changes on the emergency use authorization (EUA) of Pfizer’s COVID-19 vaccine for now while Philippine authorities await a report from the company on the death of elderly people in Norway, the Department of Health said Monday.

This after Norway reported that some elderly people with underlying health conditions died after receiving the vaccine. Experts have noted that Norwegian authorities did not categorically say the vaccine caused the deaths.

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“Studies have to be done so we can be able to validate at masasabi talaga kung 'yan ay may causality o epekto ng bakuna (and we can say if there is causality or it was an effect of the vaccine),” Health Undersecretary Maria Rosario Vergeire said during a virtual briefing.

The Food and Drug Administration (FDA) of the Philippines also said studies need to be done, according to Vergeire.

“Pfizer have to submit to the Philippine Food and Drug Administration a report regarding this matter,” she said. “And once we evaluate this report and base sa kanilang (on their) conclusions, that’s the time when the Food and Drug Administration can decide on the EUA of Pfizer here in the country.”

The FDA granted EUA to Pfizer's COVID-19 vaccine last week, the first out of four applications it has received so far. The three other applicants are AstraZeneca, Gamaleya Institute of Russia and Sinovac from China.

“For now, habang wala pang malaking sufficient evidence to say that that is caused by the vaccine, tayo po ay status quo pa rin dito sa ating binigay na EUA ng Pfizer,” Vergeire said.

(For now, while we do not have sufficient evidence to say that those deaths were caused by the vaccine, we will still be on status quo for the EUA we issued to Pfizer.)

Vergeire said the deaths should be understood in the context that the vaccine was given to critically-ill elderly patients in a facility.

She also pointed out that “in a given time, they have reported 400 reported cases of deaths among these specific sector of the population.”

“Parang sinasabi nila, this might just be coincidental because the patients are severely ill and kahit yung minor reactions sa bakuna ay naka-apekto sa kanila. That’s why it led to their death,” she said.

(They seem to be saying it’s coincidental because the patients are severely ill and even the minor reactions to the vaccine may have an effect on them. That’s why it led to their death.)

“Still they are not closing the issue. They would like to look into it further,” she added.

The Philippines' vaccine expert panel is awaiting results of Norwegian authorities' investigation, said its head Nina Gloriani.

"Kung meron mang totoong naging adverse reaction, baka dahil ang mga pasyenteng ito ay sobrang matatanda, maraming comorbidities or sakit. At hindi natin pwede basta sabihin na dahil sa bakuna," Gloriani told ABS-CBN's TeleRadyo.

(If there really was an adverse reaction, it may be because these patients were too old, had several illnesses. We cannot say it was just because of the vaccine.)

"Pero dahil masyadong marami within, let us say, a few days or 1 week, kailangan lang pong imbestigahan."

(But because there were too many deaths, within let us say a few days or 1 week, it needs to be investigated.)

Dr. Edsel Salvaña, member of the technical advisory group that advises the government's Inter-Agency Task Force (IATF) on the Management of Emerging Infectious Diseases, also said, "It's possible it may have contributed to their demise but they're (Norwegian authorities) not categorically stating that it is the vaccine that caused the death."

"It may have contributed because common side effects like fever, chills from the vaccination, which are pretty much harmless in young people, may actually stress out these elderly people who have a lot of other comorbid condition," Salvaña, also the director of the Institute of Molecular Biology and Biotechnology at the University of the Philippines - National Institutes of Health, told ANC.

Currently, COVID-19 vaccines are allowed only for emergency use because they are still under development.

The FDA has noted that only a few people out of the more than 5 million people injected with Pfizer’s vaccine in other countries showed severe allergic reactions, and there were no other safety concerns.

The DOH and the Philippine government has emphasized the need for continuous monitoring of people who will receive the vaccines.

The country, which has already recorded more than half a million coronavirus infections, expects to receive COVID-19 vaccines as early as next month.

As of Sunday, the country has 24,691 active COVID-19 cases.