The U.S. Food and Drug Administration has authorized the emergency use of Moderna’s COVID-19 vaccine. It is the second COVID-19 vaccine available for emergency use in the U.S.
Pfizer and BioNTech’s COVID-19 vaccine has already received the emergency use authorization in the U.S.
The emergency use authorization allows mRNA-1273, Moderna COVID-19 vaccine, to be distributed in the U.S for people 18 years of age and older. It was found to be 94.1 percent effective at preventing symptomatic COVID-19 in clinical trials.
An emergency use authorization means that the FDA has given the drug a special authorization to be used during an emergency period. Moderna would have to file a separate application for its vaccine to be fully approved by the FDA. Meanwhile, researchers will continue to monitor the vaccine’s effectiveness in the real world.
Moderna stated that it will continue to gather additional data and plans to file a Biologics License Application or BLA with the FDA requesting full licensure in 2021.
Moderna also said it starts immediately to deliver the vaccine to the U.S. Government. It will deliver about 20 million doses of the vaccine to the U.S. government by the end of December 2020.
The company expects to have between 100 million and 125 million doses available globally in the first quarter of 2021, with 85-100 million of those available in the U.S.
On Thursday, the FDA’s vaccine advisory committee recommended the emergency use of Moderna’s COVID-19 vaccine candidate.
Last week, Moderna said that the U.S. government exercised its option to purchase an additional 100 million doses of mRNA-1273, bringing its confirmed order commitment to 200 million doses.T
he U.S. government has the option to purchase up to an additional 300 million doses of mRNA-1273 from Moderna.
Pfizer’s and BioNTech’s COVID-19 vaccine, BNT162b2, received emergency use authorization in the U.S. last week. The companies have already started the distribution of their vaccine shots across the U.S from Monday.
Moderna’s vaccine will be enough to handle at the standard refrigerated temperatures of 2 to 8 degrees Celsius, while the Pfizer vaccine needs a deep freeze of minus 70 degrees Celsius.
On November 30, Moderna submitted an emergency use authorization request to the FDA for mRNA-1273 intended to prevent COVID-19 caused by SARS-CoV-2.
The proposed use under an EUA is for active immunization for the prevention of COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. The proposed dosing regimen is 2 doses, 100 µg each, administered 1 month apart.
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