FDA eyes limiting use of Pfizer COVID-19 vaccine in elderly Filipinos

THE Philippine Food and Drug Administration may issue an advisory on the use of Pfizer-BioNTech’s COVID-19 vaccine on the country’s elderly following reports of post-vaccination deaths among elderly patients in Norway.

FDA Director General Eric Domingo on Tuesday, January 19, said the agency may exclude elderly people with critical illnesses from the list of individuals who can receive Pfizer’s jabs.

“Possibly, magkakaroon po tayo ng (we could have) guidelines that will limit the use of the vaccine in very old, very sickly or very frail individuals,” he said during the Laging Handa briefing.

In Norway, 33 people reportedly died days after receiving their first dose of the vaccine.

Thirteen of the fatalities were people of advanced age, were frail and had serious illnesses, according to Norwegian Institute of Public Health Director Camilla Stoltenberg.

However, Norway sought to allay safety concerns on Monday, saying that there’s no established link between Pfizer’s COVID-19 vaccine and the post-inoculation deaths in the country.

It has nonetheless urged doctors to consider whether patients who are frail or terminally ill should receive the vaccine.

“It’s not impossible that some of those who have gotten the vaccine are so frail that maybe you should have reconsidered and not given them the vaccine, because they are so sick that they might have become worse from the normal side effects as the body reacts and builds up immunity,” Stoltenberg said.

The Philippines on January 14 granted an emergency use authorization (EUA) to Pfizer’s COVID-19 vaccine, allowing the vaccine to be administered to individuals 16 years old and above.

The country’s Department of Health (DOH) on Monday said Pfizer’s EUA will stay for now while officials wait for the American pharmaceutical firm to submit a report on the reported deaths of elderly people with serious underlying health conditions in Norway.

“Once we evaluate the report, the FDA can decide on the EUA based on its conclusion. For now, there is no sufficient evidence yet to say that the deaths were caused by the vaccine so we will still be on status quo for the EUA we issued to Pfizer,” Health Undersecretary Maria Rosario Vergeire said in Filipino.

She also pointed out that the deaths might be”coincidental” given the patients’ health conditions.

“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,” said Vergeire.

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

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