What will Biden do to protect children under 5 against covid?
2:03
(CNN) --
Several months after older children became eligible to be vaccinated against Covid-19, the United States could be just days away from offering vaccines to those under 5.
The Vaccines and Related Biological Products Advisory Committee (VRBPAC) of the US Food and Drug Administration (FDA) meets this Tuesday and Wednesday to discuss the modification of the emergency use authorization (EUA) of vaccines against covid-19 from Moderna and Pfizer/BioNTech to include ages younger than 5 years.
Children under the age of 5, about 18 million people, are the only US age group not eligible to receive a Covid-19 vaccine.
Moderna's vaccine is licensed for use in adults, but this Tuesday, advisers will discuss the inclusion of children ages 6 to 17;
on Wednesday, they will consider expanding the clearance to infants and children ages 6 months to 5 years.
The Pfizer/BioNTech vaccine is approved for people 16 years of age and older, and is licensed for use in children up to 5 years of age.
At Wednesday's meeting, advisers will discuss the emergency use amendment to include doses of the vaccine for infants and children ages 6 months to 4 years.
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According to FDA briefing documents released Sunday, an agency review found data support the effectiveness of the Pfizer/BioNTech COVID-19 vaccine, administered in a three-dose series, in preventing the disease in children aged 6 months to 4 years old.
According to another document, an FDA review found that Moderna's Covid-19 vaccine is also safe and effective in younger children.
At their meetings on Tuesday and Wednesday, VRBPAC members will vote on whether the benefits of Moderna and Pfizer/BioNTech vaccines outweigh the risks for younger children.
What parents need to know about covid-19 vaccines for children under 5 years of age
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What's Next After Vaccine Advisors Meet
After the FDA's vaccine advisers vote, the agency will consider their decision and weigh whether to authorize COVID vaccines for children.
However, the shots cannot be given until vaccine advisers at the US Centers for Disease Control and Prevention, CDC, have voted on whether to recommend them and CDC Director Dr. Rochelle Walensky, has approved the recommendation.
The White House has said that vaccines for younger children could be available as early as next week.
The rollout of vaccines for this group could be similar to that for older children, as pediatricians' offices will play an important role in helping vaccines reach children.
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Some pharmacy clinics are also preparing to administer more vaccines.
"We plan to provide COVID-19 vaccines to children ages 18 months to four years at our national network of 1,100 MinuteClinic locations once guidance has been provided by the FDA and CDC and inventory has been received," said Matt Blanchette. , a CVS spokesman, in an email Monday.
"Our MinuteClinic clinicians, comprised of board-certified family nurse practitioners, physician associates and nurse practitioners, have significant experience vaccinating a younger population, as well as private exam rooms, which will make the process easier to children, parents and guardians," the statement said.
Children under 5 years of age tend to have lower rates of COVID-19 cases than other age groups.
But in the first week of June, hospitalization rates among these children were slightly higher than among adults under 50 and four times higher than those of other children.
At least 481 American children under the age of 5 have died of Covid-19, according to the CDC.
Moderna's COVID-19 vaccine is safe and effective in children and youth, according to the FDA
Facts about the Pfizer vaccine for children
People 5 and older are already eligible for Pfizer/BioNTech's two-dose COVID-19 vaccine and a booster dose, but at Wednesday's meeting, VRBPAC members will discuss whether to add younger children to the authorization for emergency use.
According to a briefing paper, Pfizer's three-dose COVID-19 vaccine for children under 5 appears to be safe and generated an immune response in trials that is comparable to the response in older people.
One trial included more than 4,500 children aged 6 to 23 months and 2 to 4 years.
Some received three injections of 3 micrograms, with the second injection three weeks after the first and the third at least eight weeks after the second.
The rest received a placebo.
The FDA briefing document says that Pfizer's vaccine for this age group induced responses comparable to those seen in 16- to 25-year-olds.
There were not enough cases of Covid-19 to establish the efficacy of the vaccine in the study, but the FDA noted that this vaccine is known to be less protective against the omicron variant.
A preliminary analysis placed the efficacy of the vaccine for children under 5 years of age at 80.4%, with three cases of covid-19 in the vaccine group and seven in the placebo group.
All cases occurred while the omicron variant was dominant in the United States.
"Given the uncertainty of the covid-19 pandemic and the likelihood that SARS-CoV-2 transmission will continue for months to come, the rollout of the vaccine for use among children 6 months to 4 years of age is likely to age has a beneficial effect on associated COVID-19 morbidity and mortality in this age group," the FDA said in its analysis.
There were no cases of anaphylaxis.
There were also no reported cases of myocarditis or pericarditis (inflammation of the heart muscle and inflammation of the tissue surrounding the heart) among more than 3,000 vaccinees in the trial, but it was not a large enough group to rule out the risk.
The most common adverse reactions among children 6 to 23 months of age were irritability, drowsiness, lack of appetite, and injection site tenderness.
For children 2 to 4 years of age, the most common adverse reactions were pain or redness at the injection site and fatigue.
It is not clear how long the vaccine will be effective;
the agency noted that the evaluation period was limited and that protection is known to decline over time at older ages.
The agency also said that a booster dose is "likely to be needed in addition to the three-dose primary series to increase the strength, breadth, and duration of protection."
Fauci: Current vaccination regimen gives strong protection 0:59
Moderna vaccine data for children
The immune response and safety profile of Moderna's COVID-19 vaccine also appears to be favorable for younger children, according to FDA briefing documents.
VRBPAC members will discuss Moderna's vaccine on Tuesday and Wednesday, evaluating whether it should be licensed for younger ages.
In trials evaluating more than 6,000 children aged 6 months to less than 6 years, Moderna scientists found that two 25-microgram doses of the vaccine, given 28 days apart, produced an immune response similar to that in the series of two-dose vaccines in adults 18 to 25 years of age.
For children and adolescents ages 6 to 17, Moderna found that two doses of its vaccine provided an immune response similar to two doses in adults.
The vaccine was also found to be safe in all age groups, with adverse reactions described as "mostly mild to moderate in severity, usually of short duration" and occurring more frequently after the second dose than the first, According to the document.
Injection site pain was the most frequently reported adverse reaction.
Regarding serious adverse events, the document described them as rare and did not raise any concerns.
No deaths were reported.
Although there have been no known cases of myocarditis or pedicarditis associated with the vaccine, it is recognized as one of the known risks and has been reported primarily in men aged 18 to 24 years.
The FDA did not require vaccine manufacturers to submit vaccine efficacy data for emergency use authorization for young children, but Moderna's vaccine has been estimated to be 93.3% effective against covid-19 symptomatic among adolescents aged 12 to 17 years when the original coronavirus and the alpha variant were dominant.
The vaccine was estimated to have 76.8% efficacy against symptomatic COVID-19 for children aged 6 to 11 years when the delta variant predominated.
However, the FDA also noted that for children in that age group, "vaccine efficacy could not be reliably determined due to the small number of COVID-19 cases accumulated during the study."
The vaccine was tested during a time when the omicron variant was dominant.
It was estimated to have 36.8% efficacy against symptomatic COVID-19 for children 2-5 years of age and 50.6% protection for children 6-23 months.
Vaccine efficacy estimates "were generally consistent" with what has been seen in adults, according to the FDA briefing.
-- CNN's Amanda Sealy, Deidre McPhillips and Jamie Gumbrecht contributed to this report.
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