The Food and Drug Administration (FDA) on Thursday granted emergency use authorization (EUA) to AstraZeneca’s Covid-19 vaccine after a thorough review by the country’s medical and regulatory experts.
“It is decided that all conditions for an EUA are present and that the benefit of using the vaccine outweighs the known potential risks. The interim data from the ongoing Phase 3 trial shows that the vaccine has an efficacy of 70 percent after the first dose,” FDA Director General, Dr. Eric Domingo said in an online press briefing.
The vaccine regimen consists of two equal standard doses of 0.5 ml each, given four to 12 weeks apart.
Domingo noted that the adverse events reported are transient and are mostly mild to moderate similar to common vaccine reactions and no specific safety concerns were identified.
He said close monitoring and surveillance is needed after immunization in case more adverse events may emerge.
The EUA granted to the vaccine is not a marketing authorization or a Certificate of Product Registration, as stated under executive order no. 121.
Domingo said AstraZeneca Pharmaceuticals Philippines would supply the vaccine only to emergency response stakeholders consistent with the terms and conditions of the EUA or their designees authorized to procure the vaccine in line with the Covid-19 vaccination program.
The country has signed a deal with the company for 17 million doses of its vaccine and the first tranche of deliveries is expected to arrive in May.
AstraZeneca’s Covid-19 vaccine is the second vaccine to be granted an EUA in the country, after Pfizer-BioNTech’s Covid-19 vaccine received its EUA on Jan. 14. (PNA)
