Moderna has requested emergency use authorization (EUA) for its coronavirus vaccine in children six months to under two years, and two years to under six years, the company said Thursday.
The request was submitted to the U.S. Food and Drug Administration.
“We are proud to share that we have initiated our EUA submission for authorization for our COVID-19 vaccine for young children,” stated Stéphane Bancel, Chief Executive Officer of Moderna.
“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,” Bancel added.
We're announcing that we have submitted a request for #EUA for our #COVID19 vaccine (mRNA-1273) in children 6 months to under 2 years and 2 years to under 6 years of age to the U.S. FDA, and that similar requests are underway with international regulatory authorities. pic.twitter.com/sXF4IuBPYg
— Moderna (@moderna_tx) April 28, 2022
Pfizer and BioNTech recently said they would seek permission to give coronavirus booster shots to healthy children down to five years old.
Moderna’s news release continued:
Positive interim results from the Phase 2/3 KidCOVE study, announced on March 23, 2022, showed a robust neutralizing antibody response in the 6 month to under 6 years of age group after a two-dose primary series of mRNA-1273, along with a favorable safety profile. The antibody titers in the pre-specified 6 month to 23 month and 2 years to under 6 years age sub-groups met the statistical criteria for similarity to the adults in the COVE study, which satisfied the primary objective of the study.
The previously announced results included a supportive preliminary efficacy analysis on cases mostly collected during the Omicron wave, including home testing for COVID-19. When the analysis is limited only to cases confirmed positive for SARS-CoV-2 by central lab RT-PCR vaccine efficacy remained significant at 51% (95% CI: 21-69) for 6 months to <2 years and 37% (95% CI: 13-54) for 2 to <6 years. These efficacy estimates are similar to vaccine efficacy estimates in adults against Omicron after two doses of mRNA-1273.
The EUA request for children six months to under six years old would be finished in the coming week, and “Moderna is also currently studying booster doses for all pediatric cohorts,” the company said.
Meanwhile, the majority of children have already contracted the coronavirus, according to a study from the U.S. Centers for Disease Control and Prevention (CDC).
Breitbart News reported Wednesday the study “found that that three-quarters of children 11 and under have already contracted the virus. The federal agency tested over 200,000 blood samples, looking to identify antibodies indicating previous infection.”
In addition, the American Academy of Pediatrics (AAP) said approximately 28 percent of U.S. children have had two doses of the vaccine, but the AAP also found that in the states reporting, children accounted for between 0.00 percent and 0.27 percent of coronavirus deaths.
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