Moderna Seeks FDA Authorization Amid Effective Covid Vaccine in Teens

Moderna Seeks FDA Authorization Amid Effective Covid Vaccine in Teens

Moderna (NASDAQ: MRNA) announced Tuesday that its Covid-19 vaccine was 93% to 100% effective on adolescents from ages 12-17. The company is now the second biopharmaceutical to exhibit high efficacy within children. It strives to submit its data to the U.S. Food and Drug Administration as well as other regulators by next month.

If approved, the American pharmaceutical and biotechnology company plans on expanding the amount of shots accessible to middle and high school students before the next school year. Pfizer was cleared to vaccinate 12 to 15 year-olds at the beginning of this month.

“We are encouraged that mRNA-1273 was highly effective at preventing COVID-19 in adolescents,” Moderna CEO Stephane Bancel said in a press release. “We remain committed to doing our part to help end the COVID-19 pandemic.”

Moderna conducted a study with over 3,700 kids ranging from 12 to 17 years-old. According to the results, the vaccine triggered the same immune protection in kids as it did in adults. Furthermore, the participants experienced the same brief side effects as adults such as headaches and fatigue. The company said that vaccine proved to be 93% effective just two weeks after injecting the first dose.

It is anticipated that U.S. regulators will grant Moderna’s request for use in teens. Nevertheless, the process may take about a month, and would be approved mid-summer if the company submits its data by early June. 

Pfizer and Moderna have both begun to test on younger children, anywhere from 6-month-old babies to kids age 11. However, researchers are testing smaller doses in younger children, with results expected in the fall.

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