- 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
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.
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.
The company said the efficacy estimates with younger children are similar to those among adults against Omicron after two doses.
Hijano pointed out that these efficacy numbers also indicate the level of protection against any SARS-CoV-2 infection, which includes mild cases.
“We know that the effectiveness of the [COVID-19] vaccines is significantly higher when you measure severe disease and hospitalization,” he said.
Because children are less likely to develop severe diseases, a greater number of younger children will need to be vaccinated before researchers can see how well the vaccines protect them against severe disease and hospitalization.
Moderna also said the vaccine had a “favorable safety profile” in younger children in its Thursday news release.
The most common side effects were pain at the injection site and fever, Dr. Paul Burton, chief medical officer of Moderna, said Wednesday.
He added that no cases of myocarditis or heart inflammation occurred during the study.
This rare side effect can occur after vaccination with an mRNA vaccine. However, myocarditis is more common after coronavirus infection than after vaccination.
In December, Pfizer and BioNTech added a third dose to the study of its COVID-19 vaccine for children 6 months to 4 years of age after two doses generated a lower immune response than that seen in adolescents and young adults.
Pfizer and BioNTech also asked the FDA on Wednesday for emergency approval of a booster dose of its vaccine for children 5 through 11 years of age.
According to CNN, Moderna’s Burton said Wednesday that the company is also testing boosters in younger children, including vaccines targeted toward specific coronavirus variants.
Hijano said boosters are already recommended for everyone 12 years and older — especially in the face of the continued spread of the Omicron variant — and boosters for younger ages will likely follow.
“I think it will end up being that all of us will need at least three doses to be fully protected,” said Hijano.
It will take several weeks for the FDA to review the applications from Moderna and Pfizer/BioNTech.
Hijano recommends that parents of young children continue to take steps to protect them, such as avoiding large indoor gatherings and those two years or older wearing masks in indoor public settings.
“When the vaccine gets authorized [for younger children] — and hopefully that will be sooner rather than later — then parents who are ready can have their child vaccinated,” he said.
“For those who are hesitant, they should talk to their [healthcare] provider and get their questions answered,” he added.