The Food and Drug Administration (FDA) has authorized Pfizer-BioNTech Covid-19 vaccines for emergency use on Thursday, raising hopes that the country can roll out its national vaccination program very soon.
The development makes US-brand Pfizer the first pharmaceutical company to be granted an emergency use authorization (EUA) in the Philippines, nearly three weeks since its application.
“After a thorough review, the FDA is granting EUA to Pfizer-BioNTech Covid-19 (vaccine). The interim data from the ongoing Phase 3 trial shows the vaccine has an efficacy rate of 95 percent in the study population and at least 92 percent among all racial groups. The EUA means the benefits outweigh the known and potential risks,” FDA Director-General Eric Domingo said in a virtual press briefing.
He said the vaccine can be administered in individuals 16 years of age and older and was observed to have transient, mild to moderate side effects — a reaction similar to common vaccines. He emphasized that there were “no specific safety concerns” identified.
Due to its possible adverse effects, the FDA chief noted that the vaccine shots should only be administered by health professionals trained to manage such side effects.
“The rollout of the vaccine and use in more than 5 million people worldwide has identified severe allergic reactions in a few individuals. Therefore, the vaccinations must be done by health professionals trained to recognize and manage adverse reactions and they should have resources at hand to adequately respond,” he said.
Domingo also recommended that the inoculation should be done in hospitals because they have the facilities needed for the proper handling and storage of the vaccines. Pfizer’s vaccines require ultra-cold storage of -70 to-80 degrees Celsius — a facility only available in Metro Manila, Cebu City and Davao City.
The government is yet to officially secure doses of Pfizer vaccines but vaccine czar Carlito Galvez earlier announced that the country is expecting to receive 20 million to 40 million doses from the US-based company in June.
The Philippines is the next country to approve the emergency use of Pfizer vaccines after it showed 95 percent efficiency in a study.
Meanwhile, Chinese vaccine Sinovac has also applied for emergency use and is now under pre-assessment.
When asked if Galvez’ pronouncement that the Chinese company will be issued an EUA on 20 February, Domingo said that it will depend on how quickly the company will submit the required documents and how fast they will respond to their inquiries.
The FDA said they are now awaiting data from Sinovac’s third phase of clinical trials.