FDA will approve emergency use of Moderna’s coronavirus vaccine and notify agencies that will distribute it

EFE / Michael Reynolds
EFE / Michael Reynolds

The United States Food and Drug Administration (FDA, for its acronym in English) assured that will work quickly to issue an emergency use permit for the vaccine developed by the pharmaceutical company Moderna after an agency advisory committee recommended approval of the trial.

“Following the positive outcome of today’s advisory committee meeting on the modern COVID-19 vaccine, the US Food and Drug Administration has informed the sponsor that it will work quickly to finalize and issue an emergency use permitSays the statement from the FDA Commissioner, Stephen M. Hahn, and the director of the Center for Biological Evaluation and Research (CBER), Peter Marks.

The FDA reported it has already reported Centers for Disease Control and Prevention (CDC) and Operation Warp Speed “So they can implement their plans for the timely distribution of the vaccine.”

Yesterday, a panel of health experts recommended that the FDA grant emergency approval for Moderna’s COVID-19 vaccine.

Moderna vaccine against coronavirus.  REUTERS / Dado Ruvic / Illustration
Moderna vaccine against coronavirus. REUTERS / Dado Ruvic / Illustration

If effectively authorized, the inoculant will be the second in use in the US population, after that of Pfizer and BioNtech.

Moderna’s FDA approval paves the way for six million doses will be distributed this weekend.

The 22 members of the FDA’s Vaccine and Biologics Advisory Committee all voted for the vaccine, with a single abstinence, giving hope in a country hit by more than 300,000 deaths from COVID-19, including a daily peak of 3,580 deaths on Wednesday, while the record number of patients is hospital and health personnel.

Last Tuesday, the FDA had a positive review of the modern US laboratory vaccine against covid-19, and had been optimistic about the vaccine, and stated so showed no “specific security issues” that “prevent the issuance” of an authorization for emergencies. The agency also confirmed that the treatment was a 94.1% efficiency.

The agency’s engineers have not raised any new objections to the formula data, paves the way for the country to allow a second vaccine that would in principle be easier to handle than Pfizer’s.

It’s that while Pfizer poses complex distribution challenges due to the need to be shipped and stored at -70 degrees CelsiusThe Moderna vaccine does not require dedicated ultra-cold freezers or large amounts of dry ice, making it easy to handle and stock in rural and remote areas.



An expert panel is recommending FDA approval of Moderna’s COVID-19 vaccine in the United States

According to Jair Bolsonaro, Pfizer’s vaccine against the coronavirus could have side effects: “If you become an alligator, that’s your problem.”

Vladimir Putin said Russia is considering creating a “light” vaccine with reduced protection to supply foreign markets.