Allergic reactions to these vaccines are low, according to the CDC 2:20
(CNN) – Moderna announced on Tuesday that it requested full approval for its covid-19 vaccine for people 18 years of age and older.
The company says it will continue to send test data “continuously for the next several weeks with a priority review request.” A priority review asks the US Food and Drug Administration (FDA) to take action within 6 months, compared to the 10 months designated in the standard review.
“We are pleased to announce this important step in the US regulatory process for a Biological License Application (BLA) for our covid-19 vaccine,” Moderna CEO Stéphane Bancel said in a statement. “We look forward to working with the FDA and will continue to submit data from our Phase 3 study and complete the ongoing submission.”
Allergic reactions to these vaccines are low, according to the CDC 2:20
Since December, Moderna’s two-dose vaccine has been distributed under an emergency use authorization for people 18 years of age and older. On April 13, the company announced that its vaccine remained more than 90% effective six months later, the amount of follow-up time required to request FDA approval.
Moderna is the second company seeking such approval in the United States. On May 7, Pfizer announced that it was launching its own app for people over 16 years of age, following an announcement on April 1 that its clinical trials showed greater than 91% efficacy after six months. Experts say they expect this protection to last much longer, which will be confirmed as more data is entered.
Receiving FDA approval may motivate some people to hesitate to get this vaccine, according to research published Friday by the Kaiser Foundation.
Both Pfizer and Moderna are also studying their vaccines in children as young as 6 months. Last month, the FDA granted Pfizer’s vaccine an emergency use authorization for children ages 12 to 15.
