However, vaccines cannot be given until U.S. Centers for Disease Control and Vaccine advisers vote on whether to recommend them – the vote is scheduled for Saturday – and CDC Director Dr Rochelle Valensky has signed the recommendation. . The White House said vaccinations for younger children could begin next week.
The Moderna vaccine is now approved for use in children from 6 months to 17 years of age, and the Pfizer / BioNTech vaccine for children from 6 months to 4 years of age. About 17 million children under the age of 5 are already eligible for Covid-19 vaccines.
“Many parents, carers and clinicians are expecting a vaccine for younger children, and this action will help protect those up to 6 months of age. As we have seen in older age groups, we expect that vaccines for younger children will provide protection against the worst COVID-19 outcomes, such as hospitalization and death, “said FDA Commissioner Dr. Robert M. Calif. press release. “Those who are trusted to care for children can have confidence in the safety and effectiveness of these vaccines against COVID-19 and can be sure that the agency has been thorough in its assessment of the data.
Previously, the Pfizer / BioNTech vaccine was approved for people 5 years of age and older and was approved for people aged 16 and over, while the Moderna vaccine was only approved for adults.
Dr. Peter Marx, director of the FDA’s Center for the Evaluation and Research of Biological Substances, called the Covid-19 vaccines for younger age groups a “cornerstone.”
“It’s a bit of a milestone to reduce the age range for these vaccines as we work through it,” Marx said Wednesday at a meeting of the FDA’s Advisory Committee on Vaccines and Related Organic Products.
At this meeting, the members of the commission voted unanimously in favor of extending the permits to include children under 6 months of age.
“Being able to vote for two vaccines that will protect children under 6 months of age from this deadly disease is very important,” said commission member Dr. Archana Chatterjee, dean of the University of Chicago School of Medicine Rosalind Franklin. .
She compared the day to December 2020, when the first vaccines against Covid-19 were approved for adults and older teenagers.
“I’m really pleased that we’ve achieved this kind of milestone,” said Commissioner Dr. Ofer Levy of the Precision Vaccine Program at Boston Children’s Hospital, who also likened it to when Covid-19 vaccines were previously approved. other age groups.
“I remember our first vote a year or more ago on Pfizer’s first permission,” Levy said. “I was one of the 17 votes in favor. I remember these early discussions – even then, should 16- and 17-year-olds be included? At the time, this was a controversial topic under discussion. commission we unanimously recommend permission until the age of 6 months. So we have come a long way. “
Will the youngest children be vaccinated?
Many public health experts are concerned that although Covid-19 vaccines are now approved for younger age groups, parents of these children may not take their children to vaccinations.
There is already a slow uptake of Covid-19 vaccines among children in the United States.
“Having vaccination options for the youngest children is very important; however, we are seeing relatively low uptake of Covid vaccines in children aged 5 to 12, so my concern is that uptake in the youngest children under 5 may also be lower than we would like. ” said Dr. Dan Baruch, director of the Center for Virology and Vaccine Research at Beth Israel Diakones Medical Center in Boston, to CNN on Wednesday.
Baruch, who is not involved in the FDA’s decision, helped develop and study the Johnson & Johnson Covid-19 vaccine.
He said there were “striking” differences in how many adults were fully vaccinated compared to children and teenagers.
Children 5 to 11 were the newest group to qualify for vaccination in November. But only 29% of these children are fully vaccinated with their primary two-dose series in the United States, according to the CDC, compared to about:
- 60% of adolescents from 12 to 17 years
- 64% of adults aged 18 to 24
- 67% of adults aged 25 to 39
- 75% of adults aged 40 to 49 years
- 82% of adults aged 50 to 64
- 94% of adults aged 65 to 74
- 88% of adults aged 75 and over
“We are planning and preparing for the release of pediatric vaccines. Of course, there is a lot of work to be done to consider the spread of this vaccine. “Some of the studies that have been published show a continuing decline in parents considering giving their children these vaccines over time,” said Lori Tremel Freeman, chief executive of the National Association of County and City Health Professionals.
According to a survey by the Kaiser Family Foundation’s Vaccine Monitor published in May, only 18% of parents of children under 5 said they would vaccinate their child against Covid-19 as soon as the vaccine was available.
“I think the more the pandemic is in the rearview mirror for some people – or they believe it is – the less they will be forced to do so, so we have a big public health campaign ahead of us,” Freeman said. . “Also, local health departments will seek to understand the landscape of their community in terms of how many providers, pediatricians and pharmacies have actually registered to distribute the vaccine.
“The benefits seem to outweigh the risks”
Under FDA approval, Moderna can be given as a primary series of two doses, 25 micrograms each dose, to infants and children aged 6 months to 5 years. For older children aged 6 to 11 years, the dose is 50 micrograms.
The Pfizer / BioNTech vaccine can now be given as a primary series of three doses, 3 micrograms each dose, for use in infants and children 6 months to 4 years of age.
FDA vaccine advisers found that the benefits of both vaccines outweighed the risks and that the vaccines were “well tolerated” by children who received them in clinical trials.
“The benefits appear to outweigh the risks, especially for those with young children who may be in kindergarten or collective childcare,” said committee member Oveta Fuller, an associate professor of microbiology and immunology at the University of Michigan School of Medicine. . the modern vaccine.
Commissioner Art Reingold added that although the risk of hospitalization and death Covid-19 is lower for young children than for adults, children are already receiving vaccines to protect them from diseases at risk. short.
“If we have a vaccine whose benefits outweigh the risks, then giving it to people is a sensible choice. I would point out that we as a state continue to give a large number of vaccines to children at risk of dying or hospitalizing these diseases is close to zero, “such as polio and measles,” said Reinhold of the University of California, Berkeley.
The number of hospitalizations and deaths from Covid-19 in children is alarming and much higher than the number of deaths and hospitalizations related to influenza, Marx said.
“During the Omicron wave, there was still a relatively high hospitalization rate during this period,” he said. “This hospitalization rate is actually quite alarming, and if we compare it to what we see in a terrible flu season, it’s worse.”
Marx said that the number of deaths of children aged 4 and under in the first two years of the pandemic “also compares quite horribly with what we have seen with the flu in the past.”
“We are dealing with a problem where I think we need to be careful not to be insensitive to the number of pediatric deaths due to the huge number of elderly deaths here. Every life is important,” he said, adding that “deaths vaccine preventable 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 is widely and routinely used and accepted to prevent deaths at all ages.
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