US Confirms Emergency Use Of Modern COVID-19 Vaccine

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JAKARTA - Moderna Inc's corona virus vaccine is the second recipient of the Emergency Use Authority (EUA) from the United States Food and Drug Administration (FDA). This news was welcomed by a country with a staggering 370,000 death toll from COVID-19.

The FDA announced the approval one day after the agency's external panel of experts supported its use. Moderna said it intends to apply for full permits in the US in 2021.

The decision marks the passage of the world's first regulation for the Moderna vaccine and validation of its RNA 'messenger' technology. The decision also came less than a year after the first cases of COVID-19 were discovered in the US.

The bio-technology company has been working with the US government to prepare the distribution of injections of as many as 5.9 million doses, as soon as this weekend. The FDA ruling is based on the results of a final-stage study of 30,000 volunteers who found the vaccine to be nearly 95 percent effective in preventing disease from COVID-19 without serious safety issues.

The authorization follows the EUA awarded a similar vaccine from Pfizer Inc and German partner BioNTech SE which has been injected into thousands of US health workers this week in massive national distribution.

"With both vaccines now available for COVID-19 prevention, the FDA has taken another important step in the fight against this global pandemic that is causing a large number of deaths and hospital admissions in the US every day," said FDA Commissioner Stephen M Hahn MD, in a statement.

Moderna's vaccine injection is expected to be used in locations that are more difficult to reach, such as hospitals in remote areas. The vaccine needs to be stored and shipped frozen, but it does not require the ultra-cold temperatures required by Pfizer / BioNTech vaccines.

Once melted, the Moderna vaccine can be stored at normal refrigerator temperature. The injections were carried out twice 28 days apart from each procedure.

Moderna said it will deliver about 20 million doses to the US government this year and is expected to produce 100 to 125 million in the first quarter of next year, with 85 to 100 million doses destined for the US.

Moderna has an agreement with the US government to provide a total of 200 million doses by the end of June 2021.