FDA approves emergency use of Moderna's COVID-19 vaccine

Katrina Domingo, ABS-CBN News

Posted at May 05 2021 10:41 AM | Updated as of May 05 2021 01:12 PM

A medical worker prepares a syringe with a dose of the Moderna COVID-19 vaccine at a vaccination center in Brussels, as part of the coronavirus disease (COVID-19) vaccination campaign in Belgium, Feb. 2, 2021. Johanna Geron, Reuters/File

MANILA (UPDATE) - The Food and Drug Administration (FDA) on Wednesday said it has authorized the use of Moderna's COVID-19 vaccine for emergency use in the Philippines.

An emergency use authorization from the FDA, granted now to a total of 7 vaccine candidates, allows the product to be used in the government's inoculation program against COVID-19.

"After rigorous and thorough review by regulatory and our medical experts using the currently available published and unpublished data, the FDA is granting an emergency use authorization... for the COVID-19 vaccine Moderna," FDA Director General Eric Domingo said in an online press conference.

"The benefit of using the vaccine outweighs the known and potential risks," he said, noting that the vaccine has an overall efficacy rate of 94 percent in preventing COVID-19.

Moderna's jab may be administered to adults, with the second dose given 4 weeks after the initial inoculation, he said.

Moderna's COVID-19 vaccine, which uses mRNA, has to be stored between -15 and -25 degrees Celcius, Health Undersecretary Maria Rosario Vergeire said in a separate online press conference.

"Mayroong nakalagay na colatilla na puwede mo store sa 2-8 degrees [Celcius], basta protected from light and only for 30 days," she said.

(There is a colatilla that says it can be stored between 2 and 8 degrees Celcius as long as it is protected from light and only for 30 days.)

The Philippines has placed an initial order of 200,000 COVID-19 jabs from the American pharmaceutical giant and expects the doses to be delivered by next month.

The national government hopes to get some 20 million more Moderna jabs that will be split between public and private inoculation programs.

The Philippines has so far administered at least 2 million COVID-19 shots, a health official said on Wednesday.

Some 1.7 million people have received their first of 2 vaccine doses, said Health Undersecretary Myrna Cabotaje. Meanwhile, 320,586 second doses have been administered, a slide that she flashed during a public briefing showed.

The government aims to vaccinate up to 70 million people by the end of the year to reach herd immunity.

Vaccine czar Carlito Galvez, Jr. had said that the Philippines expects to receive 194,000 doses of the Moderna vaccine in June, along with 4.5 million doses from Sinovac, 2 million doses from Gamaleya, 1.3 million doses from AstraZeneca (private sector-procured), and more than 2.3 million Pfizer doses from COVAX facility.

This month, the government expects additional deliveries of the vaccine candidates of Gamaleya and Sinovac, and possibly of AstraZeneca from the COVAX facility, according to Galvez.

Prior to approving Moderna's EUA application, the FDA had cleared the vaccine candidates of the following for emergency use in the country: Pfizer-BioNTech, Oxford-AstraZeneca, Gamaleya Institute, Sinovac Biotech, Johnson & Johnson, and Bharat Biotech.

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