US FDA to Expedite Moderna Vaccine Approval Process...Same-Day Approval Expected
Pfizer Approval on Advisory Committee Recommendation Day
Distribution Expected Nationwide from 22nd... 5.9 Million Doses Ready for Shipment
[Asia Economy Reporter Hyunwoo Lee] The U.S. Food and Drug Administration (FDA) announced that it will swiftly approve the COVID-19 vaccine developed by Moderna, for which the Vaccines and Related Biological Products Advisory Committee (VRBPAC), an advisory body under the FDA, has recommended emergency use authorization. Previously, the FDA granted official approval for the Pfizer vaccine on the same day VRBPAC recommended its authorization, so it is expected that the Moderna vaccine will also receive approval as early as today.
On the 17th (local time), the FDA issued a statement immediately after VRBPAC recommended the use authorization for the Moderna COVID-19 vaccine, saying, "We will expedite the emergency use authorization process for the Moderna vaccine and notify the Operation Warp Speed team immediately upon approval to ensure timely distribution of the vaccine." Earlier, on the 11th, when VRBPAC recommended approval for the Pfizer vaccine, the FDA also stated it would expedite the process and granted official approval on the same day the recommendation was made.
Accordingly, some major foreign media outlets have reported that the FDA has internally completed the official approval process. Once the FDA grants official approval, the U.S. government's vaccine development and distribution project, Operation Warp Speed, will begin shipping an initial batch of 5.9 million doses of the Moderna vaccine nationwide. Subsequently, the Advisory Committee on Immunization Practices (ACIP), an advisory body to the U.S. Centers for Disease Control and Prevention (CDC), will issue a vaccination approval recommendation, and once the CDC grants official vaccination approval, inoculations will commence.
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According to CNN, in the case of the Pfizer vaccine, after the FDA's official approval on the 11th, ACIP held a vaccination approval review meeting on the 12th and issued a recommendation the same day. The CDC then granted official vaccination approval on the 13th, and vaccinations began on the 14th. If the Moderna vaccine follows the same procedure, vaccinations are expected to start between the 21st and 22nd.
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