The Food and Drug Administration (FDA) of the Philippines said it could revoke the emergency use authorization (EUA) given to Pfizer, although other things can be done if the problem is not serious.
It has not been confirmed that more than 30 elderly people in Norway, died from the coronavirus disease (COVID-19) vaccine, according to the Norwegian Institute of Public Health.
The EUA can be considered a requirement before using an in-country vaccine, particularly in situations such as pandemics.
“At any time po maaaring bawiin ang EUA. Hindi naman ito registration. Anytime we get new data katulad ng sinabi ko tungkol sa allergy o sa elderly we can always incorporate it in the EUA and revise conditions for use,” said FDA Director-General Eric Domingo.
This has also been done regarding those who have previously had severe allergies to vaccines.
“Ang mangyayari po ay mag-iingat na sa very elderly lalo na ‘yung mga more than 85 at 90 years old at saka very frail na, ‘yun talagang madaming sakit at mahinang mahina na ang katawan,” said Domingo.
The FDA also ensured that they would be given a Pfizer report immediately based on what happened.
“At least maiiwasan na natin ang mga problemang ito kapag nagkaroon ng rollout dito sa Pilipinas,” said Domingo.
EUA of vaccine provider can be revoked, changed: FDA
So far, only Pfizer has EUA among the vaccine dealers that were in talks with the government.
Meanwhile, Sinovac can now begin their clinical trials for their coronavirus disease vaccine. Sinovac from China is one of the first to bring the vaccine to the Philippines.
In a message, Domingo said that on January 15, they approved the request for a clinical trial of the Chinese pharmaceutical company.
Sinovac is the third to be given clinical trial approval after Janssen of Johnson & Johnson and Clover Biopharmaceuticals.
Some were initially skeptical of using Sinovac after clinical trials in Brazil showed that its efficacy rate was lower compared to Pfizer’s 90 percent efficacy rate.
The Philippines has been promised up to 500,000 doses from Sinovac, and the company has committed another 25 million doses.
But according to the FDA, they will not be influenced by the Sinovac donations.