However, vaccines cannot be given until vaccine advisors at the U.S. Centers for Disease Control and Prevention have voted on whether to recommend them – a vote is scheduled for Saturday – and the director of CDC Dr. Rochelle Walensky has signed this recommendation. The White House has said vaccines for younger children could begin next week.
The Moderna vaccine is licensed for children 6 months to 17 years of age and the Pfizer / BioNTech vaccine for children 6 months to 4 years of age. Some 17 million children under the age of 5 are now eligible for Covid-19 vaccines.
“Many parents, caregivers and doctors have been waiting for a vaccine for younger children and this action will help protect children under 6 months of age. As we have seen with older age groups, we hope that vaccines for younger children younger children provide protection from the most serious outcomes of COVID-19, such as hospitalization and death, “FDA Commissioner Dr. Robert M. Califf said in a press release. “People trusted by childcare can be confident in the safety and effectiveness of these COVID-19 vaccines and can be confident that the agency was thorough in its evaluation of the data.”
Previously, the Pfizer / BioNTech vaccine was approved for people over 5 years of age and approved for people over the age of 16, and the Moderna vaccine was only authorized for adults.
Dr. Peter Marks, director of the FDA’s Center for Biological Assessment and Research, described Covid-19 vaccines for younger age groups as a “milestone.”
“It’s a bit of a milestone to reduce the age range of these vaccines as we work,” Marks said Wednesday at a meeting of the FDA’s Vaccine and Related Biological Products Advisory Committee.
At that meeting, members of the committee voted unanimously in favor of extending the permits to include children up to 6 months.
“Being able to vote for the authorization of two vaccines that will protect children up to 6 months of age against this deadly disease is very important,” said committee member Dr. Archana Chatterjee, dean of the Faculty of Rosalind Franklin University of Chicago Medicine. .
He compared the day to December 2020, when the first vaccines against Covid-19 were authorized for older adults and adolescents.
“I’m very happy to have reached this milestone,” said committee member Dr. Ofer Levy, of the Boston Children’s Hospital Precision Vaccine Program, who also compared the time when vaccines against Covid-19 were previously authorized. other age groups.
“I remember our first vote a year or so ago on Pfizer’s first authorization,” Levy said. “I was one of the 17 votes in favor. I remember those first discussions – even then, should 16- and 17-year-olds be included? Back then, that was a controversial topic. And here. Now we are, as a committee, unanimously recommending the authorization up to 6 months of age. So we have come a long way. “
Will the little ones be vaccinated?
Many public health experts are concerned that while vaccines against Covid-19 are now licensed for younger age groups, parents of these children may not be able to get their children vaccinated.
There is already a slow absorption of Covid-19 vaccines among children in the United States.
“Having vaccine options for younger children is very important; however, we have seen a relatively low uptake of Covid vaccines in children in the 5 to 12 age group, so my concern is that uptake into younger children 5 years may also be shorter than we would like, “Dr. Dan Barouch, director of the Virology and Vaccine Research Center at Beth Israel Deaconess Medical Center in Boston, told CNN on Wednesday.
Barouch, who is not involved in the FDA decision, helped develop and study the Johnson & Johnson Covid-19 vaccine.
He said there were “surprising” differences in how many adults are fully vaccinated compared to children and adolescents.
Children aged 5 to 11 were the most recent group to be 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 approximately:
- 60% of adolescents aged 12 to 17 years
- 64% of adults aged 18 to 24 years
- 67% of adults aged 25 to 39 years
- 75% of adults aged 40 to 49 years
- 82% of adults aged 50 to 64 years
- 94% of adults aged 65 to 74 years
- 88% of adults 75 years and older
“We are planning and preparing for the launch of pediatric vaccines. Of course, there is a lot of work to be done to look at the adoption of this vaccine. Some of the surveys and polls that have been made public have shown a steady decline in parents. that they plan to give their children these vaccines over time, “said Lori Tremmel Freeman, executive director of the National Association of County and City Health Officials.
According to the Kaiser Family Foundation’s vaccine monitor survey published in May, only 18% of parents of children under the age of 5 said they would vaccinate their child against Covid-19 as soon as a vaccine was available.
“I think the more the pandemic is in the rearview mirror for some people, or they think it is, the less compelled they will be to do so, so we have a big public health education campaign ahead.” said Freeman. “In addition, local health departments will seek to understand the landscape of their community in terms of how many providers, pediatricians and pharmacies have actually signed up to give the vaccine.”
“The benefits seem to outweigh the risks”
Under FDA approval, the Modern Vaccine can be given as a two-dose primary series, at 25 micrograms per dose, to infants and children 6 months to 5 years of age. For older children, ages 6 to 11, doses are administered at 50 micrograms.
The Pfizer / BioNTech vaccine can now be given as a primary series of three doses, at 3 micrograms each dose, for use in infants and children 6 months to 4 years of age.
FDA vaccine advisors have determined that the benefits of both vaccines outweigh the risks and that the vaccines have been “well tolerated” among children who received them in clinical trials.
“The benefits seem to outweigh the risks, especially for those with young children who may be in kindergarten or daycare,” said Oveta Fuller, a committee member and associate professor of microbiology and immunology at University of Michigan School of Medicine. the Modern vaccine.
Committee member Dr. Art Reingold added that while the risk of hospitalization and death from Covid-19 is lower for young children than for adults, children are already vaccinated to protect them from disease. to which their risk is low.
“If we have a vaccine whose benefits outweigh the risks, then making it available to the public is a reasonable option. I would point out that we, as a country, continue to give a large number of vaccines to children where there is a risk that the child dies or dies. Hospitalization for these diseases is pretty close to zero, “said polio and measles, said Reingold of the University of California, Berkeley.
Marks said the number of hospitalizations and deaths in children for Covid-19 is worrisome and much higher compared to flu-related deaths and hospitalizations.
“There was still, during the Omicron wave, a relatively high hospitalization rate during that period,” he said. “That hospitalization rate is really worrying, and if we compare it to what we see in a terrible flu season, it’s worse.”
Marks said the death toll of children aged 4 and under during the first two years of the pandemic “also compares quite terribly to what we’ve seen with the flu in the past.”
“We are dealing with an issue where I think we need to be careful not to fall asleep in the face of the number of pediatric deaths due to the large number of elderly deaths here. Every life is important,” he said. , and added that “Vaccine preventable deaths are the ones we would like to try to do something about.”
He added that Covid-19 vaccines are an intervention similar to the flu vaccine, which has been widely used and accepted routinely to prevent deaths at all ages.