FDA says Moderna to present COVID-19 vaccine findings


Posted at Feb 02 2021 09:48 AM | Updated as of Feb 02 2021 09:58 AM

FDA says Moderna to present COVID-19 vaccine findings 1
An employee shows the Moderna coronavirus disease (COVID-19) vaccine at Northwell Health's Long Island Jewish Valley Stream hospital in New York, US, on December 21, 2020. Eduardo Munoz, Reuters/File

MANILA - The Food and Drug Administration will meet with US drugmaker Moderna on Wednesday to discuss findings on its COVID-19 vaccine, the FDA chief said Tuesday.

The drug firm has yet to apply for emergency use authorization (EUA) in the Philippines. The country has so far approved the vaccine candidates of Pfizer and AstraZeneca.

"They're (Moderna) going to present early findings and the documents that they have. I believe they will file, I hope they will file soon. Moderna has EUA from many stringent regulatory authorities and that would be quite easy to evaluate and to check," FDA director general Eric Domingo told ANC's Headstart.

Moderna earlier said it believes its COVID-19 vaccine protects against new variants first detected in Britain and South Africa, adding that it would test a new booster shot aimed at the South Africa variant after concluding that the antibody response could be diminished.

Its vaccine was 94 percent effective in preventing disease in late-stage clinical trials, and has already been given regulatory approval for use in the United States, Canada, the European Union and Israel.

The FDA will also meet with Chinese drugmaker Sinovac on Wednesday for clarifications as it has only submitted the results of their clinical trials phases 1 and 2, Domingo said.

"We’re just trying to do more evaluation. Kasi di siya (Because it's not) published in a peer-reviewed journal, these are raw data they’ve given us and our epidemiologists and biostatisticians are taking a look at the data before we discuss the actual findings," he said.

Aside from Sinovac, the FDA has also received EUA applications from India's Bharat Biotech and Russia's Gamaleya.

--With reports from Reuters

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