September 25, 2022

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Moderna COVID-19 vaccine applies to FDA for emergency use authorization for children under 6 years old

Moderna COVID-19 vaccine applies to FDA for emergency use authorization for children under 6 years old



 

Moderna COVID-19 vaccine applies to FDA for emergency use authorization for children under 6 years old

Although the vaccine protection of the COVID-19 vaccine for children under 6 years old is less than 50%, Moderna has decided to submit an application to the US FDA, hoping that its COVID-19 vaccine can obtain the US FDA Emergency Use Authorization (EUA) for 6 months to 2 years age and groups of children from 2 to 6 years old.

 

Moderna and AbCellera develop mRNA-encoded antibody therapy together

 

 

The dose of the vaccine submitted by Moderna this time is 25 micrograms, which needs to be injected in two injections.

The clinical evidence is largely based on positive interim results from the Phase II/III KidCOVE trial announced on March 23. In the trial, the vaccine showed neutralizing antibody responses in the age group of 6 months to 6 years, and had a good safety profile.

 

During the trial, when the Omicron variant was circulating in the United States, according to relevant trial data, the efficacy of the vaccine in the 6-month to 2-year-old age group was only 43.7%, and the efficacy in the 2-year-old age group was only 43.7%. 37.5%.

This is also consistent with the results of previous trials in adult patients, Moderna’s COVID-19 vaccine has weak protection against the Omicron variant.

 

Although none of the vaccines exceeded 50% efficacy, the results were statistically significant according to the trial design, and the vaccine met the secondary endpoint of efficacy.

According to a report published by the U.S. Centers for Disease Control and Prevention (CDC), as of February 2022, approximately 75 percent of children and adolescents in the U.S. had been infected with COVID-19, and unvaccinated children were more likely to be unvaccinated than vaccinated children. The hospitalization rate for children between the ages of 5 and 11 is about twice as high.

 

In addition to this, reports have surfaced that Moderna has decided to build a new manufacturing plant in Montreal within the next two years and will begin producing vaccine products in 2024.

In addition to the production of COVID-19 vaccines, the facility will also include Moderna’s research and development of mRNA vaccines for other diseases.

When completed, the plant is expected to produce up to 30 million doses of the vaccine annually.

Under the company’s agreement with Canada, Canada will receive priority access to the vaccine, and the facility will also be Moderna’s first manufacturing facility outside the United States.

 

 

 

 

 

Reference:

Moderna Makes Official Ask for Young Kids’ Vaccine, Introduces Montreal mRNA Facility

Moderna COVID-19 vaccine applies to FDA for emergency use authorization for children under 6 years old

(source:internet, reference only)


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