WASHINGTON — Moderna announced Thursday it is seeking approval from the U.S. Food and Drug Administration for emergency use of its COVID-19 vaccine in children younger than 6.
The requests are based on a 25 μg two-dose primary series of mRNA-1273. https://t.co/Jv0Jo0Gtyq
— Moderna (@moderna_tx) April 28, 2022
In a news release Thursday morning, the biotechnology company said its submission to U.S. regulators for the age group, which ranges from 6 months old to under 6 years old, “will be complete next week.” The request is based on two 25-microgram doses of the vaccine, dubbed mRNA-1273, compared with two 100-microgram primary doses and a 50-microgram booster for adults, the release said.
“We are proud to share that we have initiated our EUA submission for authorization for our COVID-19 vaccine for young children,” said Stéphane Bancel, chief executive officer of Moderna, said in a statement. “We believe mRNA-1273 will be able to safely protect these children against SARS-CoV-2, which is so important in our continued fight against COVID-19 and will be especially welcomed by parents and caregivers.”
Moderna added that interim results released last month showed that two doses of the vaccine prompted a “robust neutralizing antibody response” in young children and had “a favorable safety profile.”
According to The Associated Press, if the FDA grants Moderna’s request, the low-dose shots could be available to the young children by this summer.
The news came as the rate of new COVID-19 cases appeared to be rising domestically and declining globally, according to The New York Times. As of Wednesday, the U.S. was averaging 53,432 new cases per day, up 59% from two weeks earlier, the newspaper reported. Meanwhile, the worldwide average was 656,556 new cases per day, down 31% from 14 days earlier.
As for fatalities, the U.S. averaged 355 deaths per day – a decrease of 25% from two weeks earlier, the newspaper reported. The global average hovered at 2,959 daily deaths, down 7% from 14 days earlier.
The Centers for Disease Control and Prevention reported Wednesday that 66.1% of the U.S. population is considered fully vaccinated against COVID-19. About 45.7% of fully vaccinated residents have received a booster dose of a coronavirus vaccine, the agency said.
– The Associated Press contributed to this report.
More coronavirus pandemic coverage:
>> Coronavirus: How long between exposure to the virus and the start of symptoms?
>> How to not let coronavirus pandemic fatigue set in, battle back if it does
©2022 Cox Media Group
/cloudfront-us-east-1.images.arcpublishing.com/cmg/LH3JSJEF3VBLRJLJQESEAG34AM.png)
