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Moderna Seeks Emergency Authorization for Under-6 Covid Vaccine

Children ages 6 months to under 6 years may soon have access to a Covid-19 vaccine that has been submitted to the FDA for emergency use authorization.

The volatility in the number of new Covid-19 cases since Oct. 31, 2021, has swung wide over the past six months with remarkably high and low numbers being reported by the Centers for Disease Control and Prevention.

The U.S. has recorded a total of 81.17 million cases during over two years of the pandemic through April 29, , with 991,030 deaths reported. The number of daily new cases shot up from 25,454 on Oct. 31, 2021, to 1.26 million on Jan. 10, only to tumble down to 9,486 new cases by March 13, and reverse course again, recording 88,535 new cases on April 27.

The infection rate would likely be much higher if not for the vaccines and booster shots provided by pharmaceutical firms Moderna  (MRNA) - , Pfizer  (PFE) -  and Johnson & Johnson  (JNJ) - . The CDC reports that 82.5% of people 5 years old and older in the U.S. have had at least one vaccination shot, according its website.

The Food and Drug Administration issued its first emergency use authorization for a Covid-19 vaccine on Dec. 11, 2020 with its approval of use of the Pfizer-BioNTech vaccine for persons 16 years or older, according to the . The FDA approved Moderna's emergency use of its vaccine for persons 18 and older on Dec. 18, 2020. The federal agency approved Johnson & Johnson's Janssen vaccine emergency use for persons 18 or older on Feb. 27, 2021.

The FDA subsequently on May 10, 2021, amended its authorizations allowing emergency use of the Pfizer vaccine for adolescents ages 12 through 15, and on Oct. 29, 2021, authorized emergency use of the Pfizer vaccine for children ages 5 through 11. However, children under 5 years old have remained unprotected by vaccines since the beginning of the pandemic.

Pfizer BioNTech Moderna Lead

When Will Children Under 5 Get Covid Vaccine?

Moderna on April 28 became the first drug company to step forward to seek emergency authorization of its vaccine, mRNA-1273, from the FDA for children 6 months old to under 2 years and 2 years to under 6 years old, according to a statement.

"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, CEO 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."

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Moderna reported on March 23 that positive interim results from the Phase 2/3 KidCOVE study 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 statement said. 

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% for 6 months to under 2 years and 37% for 2 years to under 6 years. These efficacy estimates are similar to vaccine efficacy estimates in adults against Omicron after two doses of mRNA-1273, the statement said.

The emergency use authorization submission for children ages 6 months to under 6 years is expected to be completed next week.

on May 1 that the company will provide all of its data electronically to the FDA by May 9 so they can conduct their analysis. However, Burton said that Moderna has already provided the FDA with data they need to begin their study.

Burton was confident that the vaccine would be safe for children over 6 months old to under 6 years old.

"So, first of all, on safety -- and we can talk about that -- the safety profile we see with this vaccine, in these very youngest kids, was very reassuring. Actual rates of safety events, even lower than we see in the six-year-olds to 12-year-olds. So that's great," Burton told "Face the Nation."