FDA green light to authorize Moderna coronavirus vaccine

The vaccine manufactured by Moderna, based in Massachusetts is in the process of obtaining a license this same week in the United States after a thorough review of its results by the Food and Drug Administration (FDA), the Washington Post reported on Tuesday.

Thus, on the weekend, the United States could have two vaccines against the coronavirus.

The vaccine candidate developed by biotech company Moderna appears ready for regulatory approval after a detailed review of the data by scientists from the Food and Drug Administration confirmed that the scheme of two injections it was 94% effective in a clinical trial and did not pose serious safety concerns, the Post writes.

54-page document positions Moderna vaccine to follow the same historical path than the Pfizer-BioNTech vaccine.

After the FDA gave a positive review of the Pfizer-BioNTech vaccine exactly one week ago, the vaccines were approved by a panel of outside experts on Thursday and regulators gave the green light a day later. The first doses were given to health workers on Monday and vaccinations are now continuing.

This week the same schedule is planned, given the similar results of Moderna’s vaccine and the fact that it is based on the same technology underlying.

Moderna’s vaccine will be reviewed Thursday by the same panel of experts independents in a public meeting that lasts all day.

The data they will examine echoes the evidence that led to a 17-4 vote to authorize the Pfizer-BioNTech vaccine, which was 95% effective.

In addition, the regimen of two injections of Moderna has been shown to be particularly effective against the disease. There were 30 cases of severe covid-19, the disease caused by the coronavirus, during the trial, none of these cases had received the vaccine.

Also according to the Post, Moderna’s vaccine worked well, regardless of age, race and gender. The associated adverse events were generalized, but short-lived, such as fatigue, muscle pain and pain at the injection site.

6 million additional doses

In anticipation of his clearance, Gen. Gustave Perna, director of operations for the federal vaccine development and distribution effort, said on Monday that the United States was preparing to ship nearly 6 million doses of Moderna vaccines at 3,285 sites in the first week.

“It will be a very similar cadence to what has worked this week with Pfizer,” said Perna, “where we will get to the initial sites on Monday, we will continue on Tuesday and Wednesday.”

FDA Reviews of Pfizer-BioNTech and Moderna Vaccines Cements Success of a new genetic vaccine technology, which could be used to quickly create vaccines for other diseases.

Clarin writes with information from the Washington Post

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