All 21 members of the FDA’s Vaccines and Related Biological Products Advisory Committee voted “yes” in response to the question: “Based on the body of available scientific evidence, the benefits of the Moderna COVID-19 vaccine when administered as 2 doses -series (25 micrograms per dose) outweigh the risks when used in infants and children aged 6 months to 5 years?”
And all committee members voted yes in answer to the question: “Based on the body of available scientific evidence, the benefits of the Pfizer-BioNTech COVID-19 vaccine outweigh the benefits when administered as a 3-dose series (3 micrograms per dose). is its risk when used in infants and children aged 6 months to 4 years?”
The FDA, which normally follows the committee’s decisions, will now decide whether to approve the vaccines for emergency use in the youngest children.
However, vaccinations cannot be given until the U.S. Centers for Disease Control and Prevention’s own vaccine advisors have voted on whether to recommend them, and CDC Director Dr. Rochelle Walensky signed the recommendation.
CDC vaccine advisors are expected to vote on Saturday. The White House has said the shooting could begin as early as next week.
Children under the age of 5 are the only age group that cannot currently be vaccinated against Covid-19. Approximately 17 million children will be eligible for Covid-19 vaccines once approved for that age group.
“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.
“Benefits seem to clearly outweigh the risks”
“The benefits appear to clearly outweigh the risks, particularly for those with young children who may be in preschool or shared childcare,” committee member Oveta Fuller, associate professor of microbiology and immunology at the University of Michigan Medical School, said of the 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.
“If we have a vaccine with benefits that outweigh the risks, then making it available to people is a reasonable choice,” said Reingold of the University of California, Berkeley.
“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 from these diseases or being hospitalized is pretty close to zero,” he said, such as polio and measles.
The number of Covid-19 hospitalizations and deaths among children is concerning and much higher compared to flu-related deaths and hospitalizations, said FDA official Dr. Peter Marks at Wednesday’s session.
“During the Omicron wave, there was still a relatively high rate of hospital admissions during this period,” said Marks, director of the FDA’s Center for Biologics Evaluation and Research. “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.”
Marks said the Covid-19 vaccines are a similar intervention to the influenza vaccine, which has been widely and routinely used and accepted to prevent deaths.
Moderna vaccine ‘well tolerated’ in young children.
The Moderna vaccine is already approved for adults. At a meeting on Tuesday, FDA advisers unanimously voted to expand the emergency use authorization to older children and adolescents ages 6 to 17, saying it would also offer more benefits than risks.
Moderna’s Covid-19 vaccine, when given at a dose of 25 micrograms, is “well tolerated” by children as young as 6 to 5 months, said Dr. Rituparna Das, vice president of clinical development of Covid-19 vaccines at Moderna, during the meeting she described the vaccine’s safety profile in this age group and side effects.
“Pain was the most common event,” Das said. “Events in young children included fever, headache, fatigue, myalgia, arthralgia, nausea, vomiting, and chills. In infants and young children, events included fever, irritability, crying, drowsiness, and loss of appetite.”
These reactions occurred more frequently after the second dose of the vaccine and disappeared within two or three days, Das said, adding that fever is an important assessment of the vaccine’s safety for this age group.
Fever occurred in about a quarter of the children after each dose of vaccine, but more frequently after the second dose, and one case of febrile convulsions was considered related to the vaccine, Das told committee members. The child who had the seizure remained in the vaccination study and received a second dose of the vaccine with no serious events.
No deaths or cases of myocarditis or pericarditis were reported among the vaccine recipients, Das said.
“In summary, mRNA-1273 was well tolerated,” she said, using the technical name of Moderna’s vaccine. “Local and systemic reactions were observed less frequently in these youngest groups.”
Concern about the number of doses
VRBPAC member Dr. Paul Offit said in Wednesday’s session that children receiving the Pfizer/BioNTech vaccine must complete a three-dose series to receive adequate protection.
“‘The benefits outweigh the risks’ is something I can support, but I have some concerns about this vaccine,” said Offit, director of the Vaccine Education Center at Children’s Hospital of Pennsylvania.
Committee member Dr. Jeannette Lee of the University of Arkansas for Medical Sciences also expressed concern that some children may not complete all three doses and that uptake of the vaccine will be slow.
“Three cans will certainly be beneficial. I am very concerned that many of these children will not get a third dose,” she said. “My concern is that to really get what you need, you have to get the three cans.”
Data from a phase 2/3 trial of Pfizer’s vaccine included 1,678 children who received a third dose during the period when the Omicron variant coronavirus was dominant. That the vaccine appeared to be safe and had a strong immune response. The data were neither peer-reviewed nor published in any medical journal.
Antibody levels tested one month after the third dose showed the vaccine elicited an immune response similar to two doses in 16- to 25-year-olds, the companies said.
FDA briefing documents noted that there were no cases of anaphylaxis, myocarditis, or pericarditis in young children who received the vaccine in studies, and the most common side effects in children 6 to 23 months of age were irritability and sleepiness, decreased appetite and sensitivity at the injection site. In children aged 2 to 4 years, the most common side effects were tiredness, pain and redness at the injection site.
Are these children 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 found 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.
Barouch, who is not a member of the FDA Advisory Committee, helped develop and study the Johnson & Johnson Covid-19 vaccine.
He said there are “striking” 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
CNN’s Carma Hassan and Deidre McPhillips contributed to this report.