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COVID-19: Moderna Seeks Full FDA Approval For Vaccine

Moderna's COVID-19 vaccine is seeking full approval from the FDA.
Moderna's COVID-19 vaccine is seeking full approval from the FDA. Photo Credit: U.S. Air National Guard Senior Master Sgt. Andrew Moseley

With six months having passed since Moderna began clinical trials for its COVID-19 vaccine, the pharmaceutical company is seeking full approval from the Food and Drug Administration.

Moderna, which currently has emergency use authorization from the FDA to distribute its vaccine, reported in its latest trial data that it has proven 90 percent effective in preventing the symptoms of COVID-19, and 95 percent effective in the most severe cases of the virus.

Currently, no COVID-19 vaccine is fully approved by the FDA, but three - Moderna, Pfizer, and the currently questionable Johnson & Johnson - were given emergency use authorization by the agency.

Emergency use authorization allows a vaccine to become available prior to full approval in the case of public health emergencies. The FDA can revoke that authorization at any time.


“The vaccines met FDA’s rigorous scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization,” the Centers for Disease Control and Prevention said on its website.

Once it gets full approval, Moderna can begin marketing the shots directly to consumers and selling them to individuals and private companies in the US.

According to the company, there has been no evidence of blood clots linked to the use of the vaccine, and Moderna has been actively testing specific booster shots that have proven effective against certain variants of COVID.

Moderna has also been testing its vaccine on adolescents and younger Americans. Currently, the vaccine is only approved for adults 16 and older.


“I anticipate in the next year or so, we’re going to see a lot of variants,” Moderna CEO Stephane Bancel said this week. “But as more and more people get vaccinated or naturally infected, the pace of the variant is going to slow down and the virus is going to stabilize as you see with flu.”

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