CDC Director Dr. Rochelle Walensky must opt out before vaccines can be administered, which could happen as early as next week.
During Friday’s discussion of the CDC’s Advisory Committee on Immunization Practices about the vaccine, the committee heard Dr. Matthew Daley say unvaccinated people aged 5 and over were at 10 times the risk of dying from Covid-19 than those vaccinated with at least the primary series.
dr Katherine Fleming-Dutra noted at the meeting that “the benefits of vaccination are more pronounced when the disease burden is high. And we can predict that in future waves of Covid-19, the unvaccinated will continue to bear the burden of disease.”
On Saturday said Dr. Veronica McNally says she is “struck” by the impact Covid-19 has had on children.
“I am struck by these numbers: 2 million cases, 20,000 hospitalizations and over 200 deaths. And I’m also concerned that the potential seriousness of a respiratory virus in children at this age is really underestimated and parents sometimes have an unclear understanding of the long-term consequences, including MIS-C,” McNally said.
“The hard work only goes on,” Daley said after recommending the vaccine, citing the importance of telling parents “how vital these vaccines are in protecting children’s lives.”
“I hope that one day the true story will be told regarding the effort, dedication, care and compassion that went into – or prevented – this whole epidemic,” said Dr. Patricia Whitley-William.
Moderna and Pfizer/BioNTech’s Covid-19 vaccines are now approved for use in young children. On Friday, the U.S. Food and Drug Administration expanded Moderna’s emergency vaccine approvals to children 6 months to 17 years and Pfizer/BioNTech to children 6 months to 4 years.
About 17 million children under the age of 5 are now eligible for Covid-19 vaccines.
Covid-19 is the leading cause of infectious disease-related deaths in people up to the age of 19, but data shows these deaths can be prevented with vaccination, said Dr. Matthew Daley on Friday at a meeting of the CDC’s Advisory Committee on Immunization Practices.
“Covid-19 is the leading cause of death among infectious diseases for people aged 0 to 19 years. And Covid-19 is the seventh leading cause of all deaths for people ages 0 to 19,” Daley, senior investigator at the Institute for Health Research at Kaiser Permanente Colorado, told the committee.
“As of March 2022, unvaccinated individuals aged 5 and older were 10 times more likely to die from Covid-19 than those vaccinated with at least the primary series,” Daley said, adding that in other words the data “provide real-world evidence that most deaths from Covid-19 are preventable through vaccination.”
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 get them.
There is already slow uptake of Covid-19 vaccines among children.
“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, on Wednesday.
Barouch, who is not involved in FDA or CDC decisions, helped develop and study Johnson & Johnson’s 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
“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 polls 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.
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, the dose is 50 micrograms each.
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.
dr Paul Offit, an FDA vaccine advisor, said Wednesday that children who receive the Pfizer 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.
dr Jeannette Lee of the University of Arkansas for Medical Sciences, who is also a member of the FDA’s Vaccine Advisory Committee, agreed.
“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.”
According to clinical trial data, common side effects of both vaccines include injection site pain, headache, fever, chills and fatigue. The vaccines appeared to elicit similar immune responses in children as in adults.
The FDA’s Vaccines and Related Biologicals Advisory Committee found that the benefits of both vaccines outweigh the risks, noting 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 in shared childcare,” said committee member Oveta Fuller, associate professor of microbiology and immunology at the University of Michigan Medical School, in a discussion of the Moderna vaccine.
The number of Covid-19 hospitalizations and deaths among children is worrying and much higher compared to flu-related deaths and hospitalizations, said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
“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 go numb to the number of pediatric deaths because of the overwhelming number of elderly deaths here. 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.
CNN’s Virginia Langmaid contributed to this report.