Philippines grants EUA to AstraZeneca's COVID-19 vaccine

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, depende rin sa length of time kung kelan ibinigay iyong second dose,” he added. 

Domingo also said that AstraZeneca initially showed it is very effective in preventing severe COVID-19 infection.

“Iyong data ng AstraZeneca showed it is very good in preventing severe COVID-19, halos 100% rin. Kaya lang maliit pa ang datos nila, at maa-update pa ‘yan. So iyong 70% [na efficacy after first dose], kahit may nagkasakit [ng COVID-19], hindi grabe,” he added.

Domingo said that the two doses of AstraZeneca's vaccine can be administered four to 12 weeks apart on individuals aged 18 years and above. The vaccine can only be administered by the vaccine providers determined by the Department of Health.

The FDA Chief, however, clarified that close monitoring and surveillance is still needed after immunization.

AstraZeneca’s COVID-19 vaccin has posted an efficacy rate of 90% after human trials ahead of the Philippine FDA evaluation. Human trials abroad showed that it is 70% effective after two standard doses, but it improved to 90% after the first dose was reduced to half.

Domingo, however, said that AstraZeneca’s vaccine’s potential to reach a higher efficacy rate was not dependent on the amount of doses administered.

“Tuloy tuloy pa po ang clinical trials [for AstraZeneca’s vaccine], but currently it does not depend on half dose then standard dose, or standard dose then [another standard dose]. It is more [dependent] on the time difference between first and second doses,” he said.

As for adverse effects of AstraZeneca’s COVID-19 vaccine, Domingo said they were transient and mild to moderate, similar to a regular vaccine.

“Ang pananakit doon sa lugar ng injection, konting sinat, konting sakit na ulo...that can all be easily managed. Walang special na precaution up to date kasi walang specific safety concerns na naidentify,” Domingo said.

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, which only requires a standard storage temperature of 2°C to 8°C, has already secured an EUA in the United Kingdom whose regulatory authority is considered a 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 EUA 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, is not a substitute for Certificate for Product Registration and as such, cannot be used to sell the vaccine commercially.

Other COVID-19 vaccines with pending EUA application before the FDA include that of Sinovac, Gamaleya and Bharat BioTech.

Getting a vaccine is not mandatory and the individual must consent to it. —KBK, GMA News