PHL FDA closely monitoring reported adverse reactions to Pfizer vaccines in other countries

(FILES) This file photo taken on November 17, 2020 shows the logos of US pharmaceutical company Pfizer and German partner BioNTech behind syringes and vials with Covid-19 Vaccine stickers attached, as the European Medicines Agency said on December 21, 2020 that it had approved the Pfizer-BioNTech coronavirus vaccine, paving the way for inoculations to start across the EU within days. – The Amsterdam-based regulator dramatically moved the decision on the jab ahead from December 29, following pressure to accelerate the process from Germany and other EU states. (Photo by JUSTIN TALLIS / AFP)


(Eagle News) — The Food and Drug Administration (FDA) said it is coordinating with Pfizer and BioNTech so that the Philippines can be updated on developments regarding recent response to its vaccines on individuals given this inoculation in other countries.

So far, the FDA said that because of reported adverse reactions monitored in other countries in some individuals particularly in very sick elderly patients, and severe allergic reactions in persons with a history of severe allergies who had been given the Pfizer vaccines, the Philippines would take extra precautions and make sure that the said vaccines are only given to individuals outside of these groups.

This comes after reported serious side effects of the Pfizer vaccines on certain frail elderly people with pre-existing conditions or “severe underlying diseases” as had been monitored in Norway where at least 23 deaths occured after the vaccines were given as of January

The Norwegian Medical Agency monitored at least 23 deaths among frail elderly patients.

Norway is now carefully assessing all deaths that occured days after the Pfizer vaccine was given.

FDA Director General Undersecretary Eric Domingo said that as the FDA had already approved the emergency use authorization for the Pfizer vaccine, it is closely monitoring reported adverse reactions after the vaccines had been given to some elderly people in Norway.

-Revisions in administering Pfizer vaccines in Norway noted-

Domingo noted “revisions” being done in Norway in the administration of the vaccines, especially for the old and very frail.

Well, sa ngayon po sa Norway, nagkaroon sila ng konting revision doon sa kanila pong patakaran sa pagbabakuna dahil ginamit po nila ito doon sa talagang matatandang-matatanda na na maraming sakit at nanghihina, including some terminally ill individuals,” he said in a Palace briefing on Tuesday, Jan. 19.

Domingo noted that Norway is now taking extra precautions in giving the vaccine shots to those aged 85 and above, especially those with serious diseases and terminally ill patients.

Food and Drug Administration (FDA) Director General Eric Domingo in a Laging Handa Press briefing on Tuesday, Jan. 19, 2021. (Screenshot of RTVM video/Courtesy PCOO/RTVM)

So parang ang mangyayari lamang naman po ay mag-iingat na doon sa mga very elderly lalo na po iyong mga more than 85, 90 years old at saka iyong very frail na, iyon po talagang marami ng sakit at mahinang-mahina na po ang katawan,” he said.

The FDA chief noted that the early use of Pfizer vaccines outside the Philippines, gives Philippine health officials the advantage of monitoring its effects on those given the shots in other countries. They can then implement extra precautions and not give the vaccines to the sectors or population groups where there have been reported adverse affects in other countries. Although there is nothing conclusive yet, information on the effects of the vaccines in these countries where these had been administered will help the Philippines formulate guidelines in using these vaccines, he said.

-FDA coordinating with Pfizer-

Well, kami naman po ay nakipag-ugnayan na sa Pfizer para nga po kapag mayroon nang lumabas na po ang resulta ng mga pag-aaral ay ma-update po tayo. Ito naman po ang maganda na hindi tayo iyong pinaka-unang gumamit,” Domingo said.

He said that so far seven million people outside the Philippines had been given the Pfizer vaccine. The vaccine had already received emergency listing approval from the World Health Organization. Pfizer has reported an efficacy rate of around 95 percent against COVID-19 after stage 3 clinical trials, but reports of adverse reactions monitored after the vaccines had been administered are now being closely assessed. This includes reported 21 cases of anaphylaxis in the United States by the US Centers for Disease Control after the Pfizer vaccine had been administered. Anaphylaxis is a severe life-threatening allergic reaction.

As of this time, pitong milyon na po ang nabakunahan ng Pfizer at ang una pong naging pagbabago ay unang-una, doon sa mga may severe allergies, ‘no, magiging maingat tayo at hindi babakunahan iyong talagang may history ng severe allergies at ito nga po ngayon iyong pangalawa na iyon nga pong masyado nang matatanda at mahihina iyong katawan ay mukhang hindi po maaaring bigyan ng bakunang ito,” Domingo said.

“Pero aside from that, ang maganda naman po at least naiiwasan na po natin ang mga problema na ito kapag nagkaroon na ng roll-out dito sa Pilipinas,” he added.

(Eagle News Service)