FDA set to wrap up review of Moderna’s EUA application this week

FDA to finish review for Moderna's Covid-19 vaccine in PH

Moderna. AFP-Yonhap via The Korea Herald/Asia News Network

MANILA, Philippines — The Food and Drug Administration (FDA) is expected to complete this week its review of the application for emergency use authorization (EUA) of Moderna for its anti-COVID-19 vaccine.

“Patapos na ang ating evaluation dyan. Mukhang matatapos na ‘yan this week,” FDA Director General Eric Domingo said in an interview with ABS-CBN’s Teleradyo on Tuesday when asked about the status of the EUA for Moderna’s COVID-19 vaccine.

(Our evaluation for their application will soon be completed. It may be completed this week.)

Moderna applied for emergency use of its COVID-19 vaccine before the FDA on April 26.

The FDA has so far granted EUAs for the COVID-19 shots of Pfizer-BioNTech, AstraZeneca, Sinovac Biotech, Gamaleya Institute, Janssen, and Bharat Biotech.

The government and the private sector earlier signed a tripartite agreement with Moderna for 20 million vaccine doses. Under the agreement, the government will secure 13 million doses while the private sector will have seven million doses for its workers.

On top of these doses, vaccine czar Carlito Galvez Jr. said the country has also ordered an additional five million doses of the Moderna vaccine.

Philippine Ambassador to the US Jose Manuel “Babe” Romualdez earlier said that about 200,000 doses of the Moderna vaccine are expected to arrive in the Philippines in June.

JPV
Read more...