FDA Panel Recommends Emergency Use Of Moderna’s COVID-19 Vaccine
The U.S. Food and Drug Administration’s vaccine advisory committee has recommended the emergency use of Moderna’s COVID-19 vaccine candidate mRNA-1273. If authorized, it would be 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.
Earlier today, the European Union’s medicine regulator, European Medicines Agency, said that it has moved forward the date for a decision on authorizing Moderna’s coronavirus vaccine to January 6 from January 12.
Meanwhile, the FDA’s Vaccines and Related Biological Products Advisory Committee voted 20-0 with one abstention to recommend emergency use authorization for the Moderna vaccine.
The positive vote was based on totality of scientific evidence presented by the company, including a data analysis from the phase 3 clinical study, which demonstrated a vaccine efficacy rate of 94.1 percent.
The FDA is not required to follow the recommendation of the advisory committee but often does.
The FDA is expected to make a decision on emergency use authorization in the coming days.
Last Friday, the FDA issued an emergency use authorization for BNT162b2, the COVID-19 vaccine developed by Pfizer and BioNTech.
Pfizer-BioNTech has already started the distribution of their vaccine shots across the U.S on 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.
Last Friday, 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.
Those deliveries are subject to receipt of an Emergency Use Authorization from the U.S. Food and Drug Administration for the vaccine. The U.S. government has the option to purchase up to an additional 300 million doses of mRNA-1273 from Moderna.
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