Moderna has submitted a request to the Food and Drug Administration for emergency approval of its COVID-19 vaccine for children 6 months to 5 years of age.
The vaccine is a two-dose regimen.
It is one-quarter the amount given to an adult.
Moderna has submitted a request to the Food and Drug Administration (FDA) for emergency authorization of its mRNA COVID-19 vaccine for children 6 months to 5 years of age, the company said Thursday.
“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,” Stéphane Bancel, chief executive officer of Moderna, said in a news release.
The vaccine is a two-dose regimen, given at one-quarter the strength of the adult vaccine.
No COVID-19 vaccines have been authorized in the U.S. for children under 5.
While coronavirus cases have dropped sharply since the January peak of the Omicron wave, the virus continues to circulate. New Omicron subvariants — such as BA.2.12.1 — are also driving a rise in cases in some parts of the country.
This comes as mask policies and other public health measures have been largely abandoned throughout the country, leaving younger children vulnerable to coronavirus infection — and many parents anxious for a vaccine to be authorized soon.
Dr. Diego Hijano, an infectious disease specialist at St. Jude Children’s Research Hospital in Memphis, Tenn., said even though cases are currently low in many parts of the country, it makes sense to have a vaccine available to younger children before the next surge.
“It takes time for children to be fully protected,” he said, “because it’s two doses separated by several weeks, in the case of this vaccine, and then you have to wait two weeks after the second dose for full protection.”
In addition, he said there is a need to have vaccines available to protect younger children from coronavirus infection.
“We know they can get severe disease and they can be hospitalized, even if they don’t have a co-morbidity,” he said. “We also have very few options to treat [this age group] because most of the treatment options are for adults or children over 12 years of age.”
The FDA has scheduled meetingsTrusted Source of its independent vaccine advisory group for June 8, 21, and 22 to review applications by Moderna & Pfizer/BioNTech for the use of their vaccines in younger children.
The dates are tentative because none of the applications are complete, the FDA said in a statement.
However, “the agency understands the urgency to authorize a vaccine for age groups who are not currently eligible for vaccination and will work diligently to complete our evaluation of the data,” the statement said.
Similar results as for older age groups during Omicron
In March, Moderna announced that its study showed that two doses of its vaccine generated a “robust” neutralizing antibody response in children 6 months to 5 years of age.
In Thursday’s news release, the company said that the vaccine was 51 percent effective against infection in children ages 6 months to under 2 years; it was 37 percent effective against infection in children ages 2 through 5.
The analysis was limited to cases confirmed positive by COVID-19 RT-PCR tests.
While the results make the vaccine appear less effective than the vaccines for older age groups, the study was done mainly during the Omicron wave.
This variant has mutations that enable it to overcome some of the protection against infection generated by vaccines for prior infection.
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