FDA approves Covid-19 vaccines for younger children

But shots can’t be fired until vaccine advisors from the US Centers for Disease Control and Prevention vote on whether to recommend them — a vote is scheduled for Saturday — and CDC Director Dr. Rochelle Walensky signed this recommendation. The White House has announced vaccinations for younger children could begin next week.

Moderna’s vaccine is now approved for use in children aged 6 months to 17 years and Pfizer/BioNTech’s vaccine for children aged 6 months to 4 years. About 17 million children under the age of 5 are now eligible for Covid-19 vaccines.

“Many parents, carers and doctors have been waiting for a vaccine for younger children and this action will help protect children up to 6 months of age. As we have seen with older age groups, we expect that younger children’s vaccines will provide protection against the most serious consequences of COVID-19, such as hospitalization and death,” said FDA Commissioner Dr. Robert M. Califf in a press release. “Those entrusted with caring for children can be confident in the safety and effectiveness of these COVID-19 vaccines and know that the agency has thoroughly evaluated the data.”

Previously, Pfizer/BioNTech’s vaccine was approved for people ages 5 and older and 16 years and older, and Moderna’s vaccine was only approved for adults.

dr Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, called Covid-19 vaccines for younger age groups a “milestone.”

“It’s a small milestone to bring the age range down for these vaccines while we work on it,” Marks said Wednesday at a meeting of the FDA’s Vaccines and Related Biologicals Advisory Committee.

There, the committee members voted unanimously to extend the approvals to children from 6 months.

“Voting to approve two vaccines that protect children up to 6 months of age from this deadly disease is a very important thing,” said committee member Dr. Archana Chatterjee, Dean of the Chicago Medical School at Rosalind Franklin University.

She compared the day to December 2020, when the first Covid-19 vaccines were approved for adults and older teens.

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“I am very pleased that we have reached such a milestone,” said committee member Dr. Ofer Levy of the Precision Vaccines Program at Boston Children’s Hospital, who also compared the moment to when Covid-19 vaccines were approved before other age groups.

“I remember our first vote at least a year ago on Pfizer’s initial approval,” Levy said. “I was one of the 17 yes votes. I remember those early discussions – should the 16 and 17 year olds be included then? At the time, that was a controversial topic to be discussed. And here we now unanimously recommend as a committee that it be admitted up to the age of 6 months. So we’ve come a long way.”

Are the youngest vaccinated?

Many public health experts worry that even though the Covid-19 vaccines are now approved for younger age groups, parents of these children may not take their children to be vaccinated.

Uptake of Covid-19 vaccines among children in the United States is already slow.

“Having immunization options for the youngest children is very important; however, we have seen relatively low uptake of Covid vaccines among children in the 5-12 year old cohort and so my concern is that uptake in the youngest children below 5 years old may also be lower than we would like.” said dr Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center in Boston, told CNN on Wednesday.

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Barouch, who is not a party to the FDA’s decision, helped develop and study Johnson & Johnson’s Covid-19 vaccine.

He said there are “noticeable” differences in how many adults are fully vaccinated compared to children and adolescents.

Children aged 5 to 11 were the last group eligible for vaccination in November. But only 29% of these children are fully vaccinated with their two-dose primary series in the United States, according to the CDC, compared to about:
  • 60% of young people between 12 and 17 years
  • 64% of adults between 18 and 24
  • 67% of adults between 25 and 39
  • 75% of adults between 40 and 49
  • 82% of adults between 50 and 64
  • 94% of adults between 65 and 74
  • 88% of adults aged 75 and over

“We are planning and preparing for the launch of pediatric vaccines. Of course, there is still much work to be done to study the uptake of this vaccine. Some of the surveys and polls that have gone public have indicated a continued decrease in parents considering giving their children these vaccines over time,” said Lori Tremmel Freeman, chief executive officer of the National Association of County and City Health Officials.

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According to a Kaiser Family Foundation Immunization Monitor survey released in May, just 18% of parents of children under the age of 5 said they would vaccinate their child against Covid-19 once a vaccine became available.

“I think the more the pandemic is in the rear-view mirror for some people — or they think they are — the less they’ll be forced to, and that’s why we have a big public health education campaign ahead of us,” Freimann said. “Also, health departments at the local level will try to understand their community’s landscape in terms of how many providers, pediatricians and pharmacies have actually signed up to distribute the vaccine.”

“Benefits seem to clearly outweigh the risks”

Per FDA approval, the Moderna vaccine can be given to infants and children ages 6 months to 5 years as a primary series of two doses of 25 micrograms per dose. For older children aged 6 to 11 years, doses are given at 50 micrograms.

Filling vials of Pfizer/BioNTech's vaccine for younger children.

The Pfizer/BioNTech vaccine can now be administered as a primary series of three doses of 3 micrograms per dose for use in infants and children aged 6 months to 4 years.

FDA advisers vote to approve Moderna's Covid-19 vaccine for children ages 6 to 17

FDA vaccine advisors have determined that the benefits of both vaccines outweigh the risks and that the vaccines were “well tolerated” by the children who received them in clinical trials.

“The benefits appear to clearly outweigh the risks, particularly for those with young children who may be in preschool or co-creation,” said committee member Oveta Fuller, associate professor of microbiology and immunology at the University of Michigan Medical School at Moderna -Vaccine.

Committee member Dr. Art Reingold added that although young children are less at risk of Covid-19 hospitalization and death than adults, children are already being vaccinated to protect them from diseases for which they are at low risk.

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“If we have a vaccine whose benefits outweigh the risks, then making it available to people is a sensible decision. I want to point out that as a country we continue to give large numbers of vaccines to children where the risk of the child dying or being hospitalized for these diseases is pretty close to zero,” said the university’s Reingold of California, Berkeley.

The number of Covid-19 hospitalizations and deaths among children is worrying and much higher compared to flu-related deaths and hospitalizations, Marks said.

“During the Omicron wave, there was still a relatively high rate of hospital admissions during this period,” he said. “This rate of hospital admissions is actually quite worrying, and when we compare that to what we’re seeing in a terrible flu season, it’s even worse.”

Marks said the number of deaths in children under the age of 4 in the first two years of the pandemic “also compares pretty terribly to what we’ve seen with influenza in the past.”

“We are dealing with an issue where I think we need to be careful not to become deaf to the number of pediatric deaths given the overwhelming number of elderly deaths. Every life matters,” he said, adding, “Vaccine preventable deaths are ones that we would like to do something about.”

He added that the Covid-19 vaccines are a similar intervention to the influenza vaccine, which is widely and routinely used and accepted to prevent deaths in all age groups.


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