The Philippine FDA has approved the application for Emergency Use Authorization of Pfizer-BioNTech for its COVID-19 vaccine.
The vaccine developed by a Western country is the first to be granted emergency approval in the Philippines.
According to the FDA, the Pfizer application also satisfied the following EUA conditions:
a. Based on the totality of evidence available to date, including data from adequate and well-known controlled trials, it is reasonable to believe that Pfizer-BioNtech COVID-19 Vaccine may be effective to prevent, diagnose or treat COVID-19;
b. The known and potential benefits of the Pfizer-BioNTech COVID-19 Vaccine, when used to diagnose, prevent, treat COVID-19, outweigh the known and potential risks of said Vaccine as of date; and
c. There is currently no adequate, approved and available alternative to the product for diagnosing, preventing or treating COVID-19.
The FDA explained that it also factored in its decision the inclusion of Pfizer-BioNTech vaccine in the emergency use listing of the World Health Organization (WHO) and the EUAs earlier granted by other nations.
Among the countries that have already granted EUA to Pfizer-BioNTech COVID-19 vaccine are the United States of America, United Kingdom, Canada, Switzerland, and Singapore.
The vaccine may only be administered to individuals aged 16 years-old and above.
“This EUA, cannot be used as an authorization to market the vaccine commercially,” FDA Dir. Gen. Eric Domingo explained, considering that an EUA is not yet a certificate of product registration.
“Hindi pa po siya maaring ibenta sa mga botika halimbawa o sa mga doktor tapos yung maibebenta rin directly sa pasyente (It cannot yet be sold in pharmacies for example, or from doctors to their patients),” he clarified.
The FDA added that only the government, particularly the Department of Health (DOH), the NTF Against COVID-19, and other authorized stakeholders are allowed to receive Pfizer vaccine supplies.
The said vaccines also require ultracold storage facilities with -80 to -60 degrees Celsius temperature.
Other EUA applicants
Aside from Pfizer- BioNTech, other applications for EUA have been submitted by AstraZeneca, Gamaleya, and Sinovac. The vaccine developed by AstraZeneca already has an EUA in UK, Argentina, and India, while its application is undergoing evaluation in the Philippines.
The Gamaleya vaccine (Sputnik V) has been granted emergency approval in Russia, Argentina, and Belarus and is yet to submit further documents to the Philippines.
Meanwhile, Sinovac has been granted EUA in China. – Report from Mark Fetalco
