AstraZeneca's COVID-19 vaccine gets favorable recommendation after FDA evaluation

The COVID-19 vaccine manufactured by British firm AstraZeneca has earned favorable recommendations as the Philippine Food and Drug Administration (FDA) concludes its evaluation of the vaccine for possible emergency use authorization (EUA).

“Our experts had questions and AstraZeneca submitted their answer before midnight of Friday. We have finished evaluation already, I am just leafing through them and the recommendations have been positive and very favorable,” FDA director general Dr. Eric Domingo said in an interview on CNN Philippines on Wednesday.

He added that the positive recommendation “is both for the technical/quality side and the safety/efficacy side.”

Domingo said that decision on granting EUA to AstraZeneca will be out within the week.

“We will be running over time on this tonight, and we want [the decision on] it to be [turned] over within the week,” he said.

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 a Stringent Regulatory Authority (SRA) by the World Health Organization.

AstraZeneca’s COVID-19 vaccine, which it developed with Oxford University and administered in two doses, has posted an efficacy rate of 90% after human trials.

AstraZeneca has already secured an EUA in the United Kingdom whose regulatory authority is considered 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.

The Philippines is expecting its first supply of AstraZeneca vaccines before June 2021, with the bulk to arrive in 2022.   —KBK, GMA News