COVID-19: Moderna Seeks Full FDA Vaccine Approval
After six months have passed since Moderna began clinical trials for its COVID-19 vaccine, the drug company is filing for full approval from the Food and Drug Administration.
Moderna, which is currently receiving emergency approval from the FDA to distribute its vaccine, reported in its latest study data that it was 90 percent effective in preventing the symptoms of COVID-19 and 95 percent in the most severe cases of the virus has proven.
No COVID-19 vaccine is currently fully approved by the FDA, but three – Moderna, Pfizer, and the currently questionable Johnson & Johnson – received emergency approval from the agency.
Authorization for emergency use may make a vaccine available prior to full approval in public health emergencies. The FDA can withdraw this approval at any time.
“The vaccines met the FDA’s rigorous scientific standards of safety, efficacy, and manufacturing quality necessary to support emergency approval,” the Centers for Disease Control and Prevention said on their website.
With full approval, Moderna can begin marketing the recordings directly to consumers and selling them to individuals and private companies in the United States.
According to the company, there has been no evidence of blood clots related to the use of the vaccine, and Moderna has been actively testing certain booster vaccinations that have been shown to be effective against certain variants of COVID.
Moderna also tested its vaccine on teenagers and younger Americans. Currently, the vaccine is only approved for adults aged 16 and over.
“I expect we will see a lot of variations in the next year,” said Stephane Bancel, CEO of Moderna, this week. “But as more people get vaccinated or infected naturally, the pace of the variant will slow down and the virus will stabilize, as you see with the flu.”
Click here to sign up for Daily Voice’s free daily email and message notifications.