Moderna announced Thursday that it received emergency use authorization from the Food and Drug Administration for its Omicron-specific bivalent COVID-19 booster for children between 6 months and 5 years old.
The federal agency’s authorization is based on a 10 μg booster dose that follows the completion of a primary vaccination series of the company’s original vaccine. The results from the Phase 2/3 trial for adults were released last month, while the Phase 2/3 trial for young kids is currently underway, with results expected early next year.
The FDA’s decision comes amid a sluggish rollout of updated COVID-19 booster shots as the U.S. heads into what many are concerned could be a difficult winter from a public health perspective.
“With the FDA’s decision, children and adolescents of all age groups in the U.S. will now be eligible for our updated bivalent COVID-19 booster, providing families with an important protective tool as we continue through the winter months,” Moderna CEO Stéphane Bancel said in a statement. “We appreciate the FDA’s timely review.”
Moderna announced the EUA news three days after Pfizer and BioNTech submitted an application to the FDA for an EUA for their Omicron-specific bivalent COVID-19 booster children between 6 months and 4 years old.
“I am deeply motivated to be building platforms that not only solve core business issues but drive a positive impact on the people we serve,” Miller said in a statement. “I’m incredibly excited to bring this passion to my role at Moderna and drive the company’s broader mission of harnessing the power of mRNA technology to create transformative medicines for patients.”
For Moderna, it’s been a mixed bag of news heading into the final stretch of 2022.
In its latest earnings report, Moderna reported that quarterly revenue dropped from $4.9 billion in Q3 2021 to $3.4 billion in Q3 2022, due in large part to a dropoff in sales of its COVID-19 vaccine. The pharma company’s net income also dropped more than $2 billion year-over-year while expenses rose about $700 million.
However, Moderna also expanded its headcount to 3,700 employees and named a new CFO after the previous one left following two days on the job.
Last month, research published in the Journal of the American College of Cardiology found that the risk of heart inflammation is up to two or three times higher among people who took the Moderna COVID-19 vaccine compared to those who took Comirnaty.