The Philippine Food and Drug Administration (FDA) may revise the conditions for the use of Pfizer-BioNTech COVID-19 vaccine if issues concerning its safety are proven.
It was recently reported that 29 individuals died in Norway after receiving shots of the said vaccine. The incident is now under investigation.
The Norwegian Medicines Authority reported that the deaths involve individuals above 80 years-old with underlying medical conditions.
“Anytime po na we get new data, katulad ng allergies or sa elderly (Anytime we get new data like allergies or among the elderly), we can always incorporate it in the EUA and revise the conditions for use,” Philippine FDA Dir. Gen. Eric Domingo explained.
“Pagkatapos po noon at mayroon po talaga tayong safety concern na makikita sa ibang bansa or dito lang sa atin (After that, if there are safety concerns found in other countries and back home), the FDA can revoke the EUA at any time,” Domingo added.
The vaccine of Pfizer-BioNTech against COVID-19 is the first one to be granted Emergency Use Authorization (EUA) in the country and was already administered in foreign countries.
There are currently three applications for EUA with the FDA, including China-based Sinovac, the vaccine doses of which are set to arrive in the country next month. The FDA is still waiting for the third phase clinical trial results of Sinovac before starting its evaluation. The vaccines cannot be used without an EUA.
Regarding the donated vaccines, Domingo explained that the Department of Health (DOH) may accept medicines which are not yet registered in the Philippines but are already registered in its home country as long as it “will be used under the supervision” of DOH.
The DOH said it “will wait for the issuance of an EUA by the Philippine FDA before [they] accept and administer the donated vaccines” and with vaccines that will be procured. – Report from Mark Fetalco
