Moderna on April 28 said it has asked the U.S. Food and Drug Administration (FDA) to grant emergency use authorization (EUA) to the company for its COVID-19 vaccine for children as young as 6 months.
The EUA submission is for two 25-microgram doses of the shot, mRNA-1273, in children 6 months old to 5 years old.
“We are proud to share that we have initiated our EUA submission for authorization for our COVID-19 vaccine for young children,” Stéphane Bancel, Chief CEO of the Massachusetts-based biotechnology firm, 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.”
SARS-CoV-2, also known as the CCP (Chinese Communist Party) virus, causes COVID-19.
“We have received a request from Moderna for an EUA for its COVID-19 vaccine for children 6 months to 6 years of age. As the company has acknowledged, they still need to submit additional data to complete its request. FDA cannot reach a decision on any vaccine without a completed EUA request, which allows us to do a thorough review, which includes, among other things, a comprehensive review of all of the adverse events and replication of the key analyses,” an FDA spokesperson told The Epoch Times in an email.
Moderna announced results from its trial in March, saying the vaccine triggered a similar immune response to that seen in adults.
But the shot also provided substandard protection against infection and the company could not measure its shielding against severe disease, prompting some experts to say the data does not warrant authorization.
The risk-benefit calculus for both the Moderna and Pfizer vaccines has become murkier over time, especially for children, as the shots provide little protection against infection from the Omicron virus variant, although they have held up better against severe disease.
Other experts have backed clearing Moderna’s shot for young kids, and many parents have been vocal about wanting to have their children vaccinated.
“The lack of immunization options for children under five has become a dire situation,” Dr. Elias Kass, a physician in Washington state, alleged during a recent government meeting.
Dr. Dorian Fink, an FDA official who took part in the meeting, told those who speak that officials at the agency knew that many parents and health care providers “are anxious to have COVID vaccines available to this age group.”
“Once FDA is in receipt of one or more submissions for emergency use authorization of COVID vaccines for these younger pediatric age groups, we will work diligently to review the data, to independently verify the analyses, and to bring those data to our advisory committees for discussion and consideration for regulatory action,” he added.
The agency spokeswoman said that “we recognize parents are anxious to have their young children vaccinated against COVID-19 and while the FDA cannot predict how long its evaluation of the data and information will take, we will review any EUA request we receive as quickly as possible using a science-based approach.”
All Americans 5 and older can get Pfizer’s COVID-19 vaccine. All Americans 18 and older can get Moderna’s COVID-19 vaccine.
Moderna’s submission comes after Pfizer’s trial examining two shots of its vaccine in young children failed to generate an adequate immune response. Pfizer shifted the trial to a three-shot primary regimen and hopes to have updated results soon.