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A health worker draws the Moderna COVID-19 vaccine as she prepares to administer a booster shot at a vaccination clinic. SOPA Images/Getty Images
  • Moderna has submitted a request to the FDA for emergency approval of its COVID-19 vaccine for children 6 months to 5 years of age.
  • The vaccine is a two-dose regimen, given at one-quarter the dose for adults.
  • The FDA’s vaccine advisory committee will meet in June to review applications from Moderna and Pfizer/BioNTech for their COVID-19 vaccines for younger children.

Next week an independent vaccine advisory group at the Food and Drug Administration (FDA) will decide whether or not to recommend that children ages 6 months to 5 get access to Moderna’s COVID-19 vaccine.

In April, Moderna 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.

“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 at the time.

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 many 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 in an earlier interview that vaccines are needed 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 a meeting of its independent vaccine advisory group for June 15 to review applications by both Moderna and Pfizer/BioNTech for the use of their vaccines in younger children.

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 April’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, including 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.

In April’s news release, Moderna also said the vaccine had a “favorable safety profile” in younger children.

The most common side effects were pain at the injection site and fever, Dr. Paul Burton, chief medical officer of Moderna, said in a statement.

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.

The FDA delayed its review of this vaccine for younger children until the company submitted data on a third dose. The companies released a summary of this data on May 23.

This showed that three doses of the vaccine was 80.3 percent effective at preventing infections in this age group, at a time when Omicron was the predominant variant.

Pfizer and BioNTech also asked the FDA for emergency authorization of a booster dose of its vaccine for children 5 through 11 years of age. The FDA authorized this booster on May 17.

In his April interview with CNN, Moderna’s Burton said that the company is also testing boosters in younger children, including vaccines targeted toward specific coronavirus variants.

On June 8, the company said data showed that a booster containing both the currently approved vaccine (Spikevax) and a candidate vaccine targeting Omicron generated a strong antibody response against Omicron. This study was done in adults.

Hijano said boosters are already recommended for everyone five years and older — especially in the face of the continued spread of the Omicron variant — and vaccines 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.

As of June 2, the Centers for Disease Control & Prevention reports that in the United States over 1,080 children under 18 years old have died of COVID-19 since the start of the pandemic.

This is out of more than one million Americans who have died of COVID-19, making this group the lowest risk group.

However, over 120,000 children have been hospitalized during the pandemic, the agency’s data shows. Over 200 children a day are still ending up in the hospital due to a coronavirus infection.

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.