Moderna’s Covid-19 Vaccine Works Safely in Kids, Including Those Under Age 5, FDA Says
Moderna Inc.’s
Covid-19 vaccine was effective at preventing symptomatic disease in children ages 6 months through 5 years, Food and Drug Administration staff said in a review of the evidence.
The FDA staff also said Friday that Moderna’s vaccine was generally safe in children in studies, including those under 5 years who haven’t had access to any shots.
The assessment of the vaccine, part of the FDA’s standard process for deciding whether to permit use of a medicine, might bode well for the prospects that the agency will authorize the Moderna vaccine’s use in young kids.
“Available data support the effectiveness of the Moderna Covid-19 vaccine in preventing symptomatic Covid-19 in pediatric age groups from 6 months through 17 years of age,” the FDA said.
The FDA’s analysis did find, however, that the two-dose vaccine wasn’t as effective when tested in children while the Omicron variant was dominant, compared with its performance while earlier strains of the virus were common.
Vaccinations could begin as soon as June 21 if the FDA authorizes either the Moderna or Pfizer Inc.-
BioNTech SE
vaccine, or both, and if they are also recommended by the Centers for Disease Control and Prevention.
Children under 5 years are the last remaining group still ineligible for Covid-19 vaccination. The Pfizer-BioNTech vaccine was previously cleared for everyone ages 5 and older, while Moderna’s is authorized for adults 18 years and older.
The FDA’s review will inform meetings scheduled for next week of a committee of outside advisers. The advisory panel is due to vote Tuesday on whether Moderna’s vaccine should be used in 6- to 17-year-olds.
On Wednesday, the panel is scheduled to consider whether to recommend the use of Moderna’s vaccine in children ages 6 months through 5 years, and the Pfizer-BioNTech vaccine for children 6 months through 4 years.
The FDA staff review of the Pfizer-BioNTech vaccine in young children might become available on Monday.
For its review, FDA staff looked at results from two studies testing Moderna’s shot against a placebo in 14,000 volunteers.
The FDA said Moderna’s vaccine was 93% effective in adolescents in a study conducted when the original virus strain and the Alpha variant were predominant. It was 77% effective in children 6 to 11 years when the Delta variant was circulating.
It was 37% effective for 2- to 5-year-olds and 51% effective for children 6 to 23 months, in a study when the Omicron variant was predominant.
No severe cases of Covid-19 were observed among children in the studies, the FDA said. There weren’t enough Covid-19 cases in children who had a prior infection to reliably estimate the vaccine’s efficacy for this subgroup, the FDA said.
The FDA said children 6 months to 11 years old had lower rates of side effects than adolescents and young adults, with the exception of fever, which was reported more frequently in the younger age groups.
The agency said two heart-inflammation conditions, known as myocarditis and pericarditis, are risks associated with Moderna’s vaccine, especially in the first week after the second dose and among men 18 to 24 years. But the FDA said there weren’t any confirmed cases among study subjects ages 6 months through 17 years.
Pediatricians and infectious-disease specialists say children should get the Covid-19 vaccine, if eligible, because they still face some risk from infection and severe disease, even if that risk is lower than for older adults.
Hospitalization rates among children surged during the Omicron wave in the winter. And health authorities have also encouraged child inoculations to reduce transmission of the virus to older adults and family members, though that benefit may not be long-lasting.
Some parents have been eager to vaccinate their children, to protect them from Covid-19 and allow families to resume travel and other activities. Yet polls show others don’t want their kids vaccinated because they view the risk of Covid-19 as less severe in children, or have concerns about risks of the vaccine.
There may be high initial demand for the use of Moderna’s vaccine for children 5 years and under, however, since they haven’t previously had access to any vaccine.
Moderna has proposed using varying dose levels for different age groups. In adolescents, it is the same dose as the primary vaccine series for adults. The dose for children ages 6 to 11 is half of that dosage, and the dose for children under age 6 is one-fourth of the adult dose.
Moderna initially asked last year for authorization of the shot in adolescents 12 years and up, but regulators delayed a decision over concerns about the shot’s risk of causing myocarditis and pericarditis in adolescents.
More than 40 other countries have authorized the use of Moderna’s vaccine in adolescents 12 to 17 years, the company has said.
Moderna more recently requested FDA authorization of uses of its vaccine in children ages 6 through 11, and 6 months through 5 years.
Even if the FDA authorizes the use of Moderna’s vaccine in children 6 and older, demand in this age group may be limited since the Pfizer-BioNTech vaccine has already been available for these age groups.
About 59.6% of 12- to 17-year-olds in the U.S. have been fully vaccinated against Covid-19 with Pfizer’s vaccine, while the full vaccination rate in 5- to 11-year-olds is only 29.2%, according to the Centers for Disease Control and Prevention.
Write to Peter Loftus at [email protected]
Copyright ©2022 Dow Jones & Company, Inc. All Rights Reserved. 87990cbe856818d5eddac44c7b1cdeb8
Moderna Inc.’s
Covid-19 vaccine was effective at preventing symptomatic disease in children ages 6 months through 5 years, Food and Drug Administration staff said in a review of the evidence.
The FDA staff also said Friday that Moderna’s vaccine was generally safe in children in studies, including those under 5 years who haven’t had access to any shots.
The assessment of the vaccine, part of the FDA’s standard process for deciding whether to permit use of a medicine, might bode well for the prospects that the agency will authorize the Moderna vaccine’s use in young kids.
“Available data support the effectiveness of the Moderna Covid-19 vaccine in preventing symptomatic Covid-19 in pediatric age groups from 6 months through 17 years of age,” the FDA said.
The FDA’s analysis did find, however, that the two-dose vaccine wasn’t as effective when tested in children while the Omicron variant was dominant, compared with its performance while earlier strains of the virus were common.
Vaccinations could begin as soon as June 21 if the FDA authorizes either the Moderna or Pfizer Inc.-
BioNTech SE
vaccine, or both, and if they are also recommended by the Centers for Disease Control and Prevention.
Children under 5 years are the last remaining group still ineligible for Covid-19 vaccination. The Pfizer-BioNTech vaccine was previously cleared for everyone ages 5 and older, while Moderna’s is authorized for adults 18 years and older.
The FDA’s review will inform meetings scheduled for next week of a committee of outside advisers. The advisory panel is due to vote Tuesday on whether Moderna’s vaccine should be used in 6- to 17-year-olds.
On Wednesday, the panel is scheduled to consider whether to recommend the use of Moderna’s vaccine in children ages 6 months through 5 years, and the Pfizer-BioNTech vaccine for children 6 months through 4 years.
The FDA staff review of the Pfizer-BioNTech vaccine in young children might become available on Monday.
For its review, FDA staff looked at results from two studies testing Moderna’s shot against a placebo in 14,000 volunteers.
The FDA said Moderna’s vaccine was 93% effective in adolescents in a study conducted when the original virus strain and the Alpha variant were predominant. It was 77% effective in children 6 to 11 years when the Delta variant was circulating.
It was 37% effective for 2- to 5-year-olds and 51% effective for children 6 to 23 months, in a study when the Omicron variant was predominant.
No severe cases of Covid-19 were observed among children in the studies, the FDA said. There weren’t enough Covid-19 cases in children who had a prior infection to reliably estimate the vaccine’s efficacy for this subgroup, the FDA said.
The FDA said children 6 months to 11 years old had lower rates of side effects than adolescents and young adults, with the exception of fever, which was reported more frequently in the younger age groups.
The agency said two heart-inflammation conditions, known as myocarditis and pericarditis, are risks associated with Moderna’s vaccine, especially in the first week after the second dose and among men 18 to 24 years. But the FDA said there weren’t any confirmed cases among study subjects ages 6 months through 17 years.
Pediatricians and infectious-disease specialists say children should get the Covid-19 vaccine, if eligible, because they still face some risk from infection and severe disease, even if that risk is lower than for older adults.
Hospitalization rates among children surged during the Omicron wave in the winter. And health authorities have also encouraged child inoculations to reduce transmission of the virus to older adults and family members, though that benefit may not be long-lasting.
Some parents have been eager to vaccinate their children, to protect them from Covid-19 and allow families to resume travel and other activities. Yet polls show others don’t want their kids vaccinated because they view the risk of Covid-19 as less severe in children, or have concerns about risks of the vaccine.
There may be high initial demand for the use of Moderna’s vaccine for children 5 years and under, however, since they haven’t previously had access to any vaccine.
Moderna has proposed using varying dose levels for different age groups. In adolescents, it is the same dose as the primary vaccine series for adults. The dose for children ages 6 to 11 is half of that dosage, and the dose for children under age 6 is one-fourth of the adult dose.
Moderna initially asked last year for authorization of the shot in adolescents 12 years and up, but regulators delayed a decision over concerns about the shot’s risk of causing myocarditis and pericarditis in adolescents.
More than 40 other countries have authorized the use of Moderna’s vaccine in adolescents 12 to 17 years, the company has said.
Moderna more recently requested FDA authorization of uses of its vaccine in children ages 6 through 11, and 6 months through 5 years.
Even if the FDA authorizes the use of Moderna’s vaccine in children 6 and older, demand in this age group may be limited since the Pfizer-BioNTech vaccine has already been available for these age groups.
About 59.6% of 12- to 17-year-olds in the U.S. have been fully vaccinated against Covid-19 with Pfizer’s vaccine, while the full vaccination rate in 5- to 11-year-olds is only 29.2%, according to the Centers for Disease Control and Prevention.
Write to Peter Loftus at [email protected]
Copyright ©2022 Dow Jones & Company, Inc. All Rights Reserved. 87990cbe856818d5eddac44c7b1cdeb8
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