Moderna seeks authorization for COVID vaccine in children under six

Moderna has requested an emergency use authorization (EUA) for its coronavirus vaccine in children six months to under two years of age and two years to under six years of age, the company announced Thursday.

The application has been submitted to the United States Food and Drug Administration.

“We are proud to share that we have initiated our EUA submission for the authorization of our COVID-19 vaccine for young children,” said Stéphane Bancel, Chief Executive Officer of Moderna.

“We believe that 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. caregivers,” Bancel added.

Pfizer and BioNTech recently said they would seek permission to give coronavirus boosters to healthy children up to age five.

Moderna’s press release continued:

Positive interim results from the Phase 2/3 KidCOVE study, announced March 23, 2022, showed a robust neutralizing antibody response in the 6 month to <6 year age group following a two-dose primary series of mRNA-1273, as well as a favorable safety profile. Antibody titers in the pre-specified age subgroups of 6 months to 23 months and 2 years to less than 6 years met the statistical criteria for similarity to adults in the COVE study, which satisfied the main objective of the study.

Previously announced results included a preliminary supporting efficacy analysis on cases primarily collected during the Omicron wave, including home testing for COVID-19. When the analysis is restricted to only cases confirmed positive for SARS-CoV-2 by the central laboratory, the efficacy of the RT-PCR vaccine remained significant at 51% (95% CI: 21-69) for 6 months at <2 years and 37% (95%% CI: 13-54) for 2 to <6 years. These efficacy estimates are similar to adult vaccine efficacy estimates against Omicron after two doses of mRNA-1273.

EUA’s application for children six months to under six years of age would be completed within the next week, and “Moderna is also currently investigating booster doses for all pediatric cohorts,” the company said.

Meanwhile, the majority of children have already contracted the coronavirus, according to a study by the US Centers for Disease Control and Prevention (CDC).

Breitbart News reported Wednesday that the study “found that three-quarters of children 11 and under have already contracted the virus. The federal agency tested more than 200,000 blood samples, looking to identify antibodies indicating previous infection.

In addition, the American Academy of Pediatrics (AAP) stated that approximately 28% of American children had received two doses of the vaccine, but the AAP also found that in reporting states children comprised between 0.00% and 0.27% of coronavirus deaths.




Breitbart

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