FDA: Moderna applies for EUA of its COVID-19 vaccine in PH
The Food and Drug Administration (FDA) said US-based drugmaker Moderna has applied for an emergency use authorization (EUA) of its vaccine against the coronavirus disease (COVID-19) in the Philippines.
FDA Director General Eric Domingo said the US-based drugmaker filed its emergency use authorization (EUA) application before the regulatory body on Monday, April 26.
Based on the latest data from the Department of Health (DOH), Moderna vaccine uses an mRNA technology platform, and requires two doses with 28 days apart.
The jab has a storage requirement of -25 to -15 degrees Celsius, or 2 to 8 degrees Celsius if stored for 30 days.
It has an efficacy rate of 94.1 percent “against symptomatic COVID-19,” while 100 percent “against severe COVID-19” based on the vaccine’s Phase Three clinical trial data.
Earlier this month, Domingo said the FDA expects that they would not have too much difficulty in evaluating the application of Moderna because it already has an EUA from other regulatory authorities.
“Pag ganito kasi talagang mas nababasa natin lahat nung mga evaluation reports ng mga nauna sa atin, at mas mabilis nating nagagawan ng desisyon (In this case, we can really read all the evaluation reports of those before us, and we can make decisions faster),” he said.
On April 19, the FDA has allowed the emergency use of COVID-19 vaccines developed by India’s Bharat Biotech and Belgium-based Janssen Pharmaceuticals.
The FDA earlier granted an EUA to COVID-19 vaccines developed by US-drugmaker Pfizer, British firm AstraZeneca, Russia’s Gamaleya Research Institute, and China’s Sinovac Biotech.