MANILA, Jan 28 (Mabuhay) — The Philippine Food and Drug Administration (FDA) has granted emergency use authorization for AstraZeneca’s COVID-19 vaccine, its director-general, Dr. Eric Domingo, announced on Thursday.
This makes AstraZeneca, a British pharmaceutical firm, the second company to secure an EUA in the Philippines after Pfizer BioNTech.
Domingo said AstraZeneca’s COVID-19 vaccine, which it developed with Oxford University, has posted an efficacy rate of 70% after first dose.
“All conditions for EUA are present, and the benefit of using the vaccine outweighs potential risk,” Domingo said during the day’s Laging Handa briefing.
“The interim data, taken in its entirety, showed an efficacy rate of 70% after the first dose. Tumataas ito pagkatapos bigyan ng second dose,” he added.
The Philippines has already inked a supply deal for 17 million doses of COVID-19 vaccine from AstraZeneca so far, a number that is good for around 8.5 million individuals since it is administered in two doses. These AstraZeneca doses, however, are expected to arrive only by June this year.
AstraZeneca’s vaccine, which it developed with Oxford University, has posted an efficacy rate of 90% after human trials ahead of the Philippine FDA evaluation.
The firm has already secured an EUA in the United Kingdom whose regulatory authority is considered Stringent Regulatory Authority (SRA) by the World Health Organization.
An Executive Order issued by President Rodrigo Duterte in November 2020 has allowed the FDA to issue an EUA on COVID-19 vaccines within 21 days since the vaccine-maker submitted its application, provided that such vaccine already secured an EUA from other regulatory bodies classified as SRA by WHO.
The Philippine FDA earlier granted EUA to Pfizer-BioNTech COVID-19 vaccine after it was found to be 95% and 92% effective in a study population and among all races, respectively.
Likewise, the FDA said that Pfizer-BioNTech COVID-19 vaccine can be administered to 16 years old and above and that its side effects were found to be transient, mild to moderate and similar to common vaccine reactions.
A vaccine needs to secure an EUA from the FDA for it to be legally administered in the Philippines. An EUA, however, does not allow commercial use of the vaccine.
Other COVID-19 vaccines with pending EUA application before the FDA include that of Sinovac, Gamaleya and Bharat BioTech. (MNS)