'Not for the very old, very frail': FDA eyes advisory on Pfizer COVID-19 vaccine


Posted at Jan 19 2021 10:47 AM | Updated as of Jan 19 2021 11:01 AM

'Not for the very old, very frail': FDA eyes advisory on Pfizer COVID-19 vaccine 1
A healthcare worker holds a vial of AstraZeneca coronavirus disease (COVID-19) vaccine at the Pentland Medical Practice, in Currie, Scotland, Britain Jan. 7, 2021. Russell Cheyne, Pool, Reuters

MANILA - The Food and Drug Administration is eyeing an advisory on the use of the Pfizer-BioNTech's COVID-19 vaccine following 33 deaths among elderly people who received their first dose of the vaccine in Norway. 

The Philippines earlier granted an emergency use authorization to Pfizer which will remain but there might be a "revision and advisory" against its use on "very old and very frail" individuals, FDA director general Eric Domingo told ABS-CBN's Teleradyo.

"Wala naman po sa ngayon, di pa rin po nagbabago ng guidelines on the use. Ini-investigate na po ang nangyari. Mukhang magkakaroon lang po siguro ng parang revision at advisory against the use of the vaccine on 'yun pong mga very old at very frail," Domingo said.

(There's no changes on the guidelines as of now. It's still under investigation. It looks like there might be revision and advisory against the use of the vaccine on the very old at very frail.)

"Kasi mukhang ang nangyari po sa Norway is pati 'yung mga matatandang-matanda na at mahihina ay binakunahan. Mga terminally ill po ata pati 'yung iba. Mga nasa nursing home po kasi."

(It seems what happened in Norway was that people of advanced age and those who were very frail were vaccinated. Some were terminally ill. They were in a nursing home.)

Norway has said no link has been established between the inoculation and the deaths but recommended doctors consider the overall health of the most frail before giving them the jab.

Of the 13 cases analyzed in detail so far, "they are people of advanced age, are frail and have serious illnesses, all of them," the director of the Norwegian Institute of Public Health Camilla Stoltenberg told reporters.

"When it comes to causes there hasn't been any analysis done yet," she added.

"It is important to remember that on average about 45 people die every day at nursing homes in Norway, so it's not given that this represents any excess mortality or that they are related to the vaccines," she said.

Norway has stressed that doctors should individually consider whether patients who are frail or terminally ill should receive the vaccine, as is also recommended in some other countries.

"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 Norwegian Medicines Agency said last week that normal side effects from messenger RNA vaccines, such as fever and nausea, "may have contributed to a fatal outcome in some frail patients."

A number of countries, including Norway's neighbors Denmark, Finland, Iceland and Sweden, have reported post-vaccination deaths but no direct links to the vaccine have been established. 


Meanwhile, the FDA said it is close to approving for emergency use the COVID-19 vaccine of British drugmaker AstraZeneca.

Government and private firms have secured some 17 million doses of the AstraZeneca vaccine so far, with an initial batch arriving in July, Malacañang earlier said.

An emergency use authorization allows vaccines to be imported, distributed and administered in the Philippines through a national immunization program.

“Yun pong pinakamalapit po siguro ‘yung AstraZeneca kaya lang may mga katanungan pa ang experts natin sa kanila, at mukhang sasagot po by Friday pa," Domingo said.

(The closes to approval is AstraZeneca but our experts still have questions which they might answer by Friday.)

Watch more on iWantTFC