In a unanimous vote, a committee of independent experts convened by the Centers for Disease Control and Prevention (CDC) today recommended the Pfizer-BioNTech COVID-19 vaccine for children ages 5-11. CDC director Dr. Rochelle Walensky will take the advice of the committee into account and will make a final decision shortly.
The CDC committee’s recommendation follows on from last week’s decision by the Food and Drug Administration (FDA) to approve the Pfizer BioNTech vaccine for the youngest population yet. The vaccine for this age group is one third of the adult dose and is given in two doses one month apart. The FDA approved vaccination for the entire age group, but it was up to the CDC to decide whether all children ages 5-11 should be vaccinated or whether only a subgroup should be vaccinated.
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Ultimately, the CDC committee decided that all children in this age group – approximately 28 million – should be vaccinated against COVID-19. Members weighed the evidence presented by Pfizer-BioNTech as well as data from CDC experts on how common COVID-19 infections are in this child population and how the disease affects them. CDC scientists found that 1.9 million cases of COVID-19 have occurred in children ages 5-11 and that although most cases are mild, 8,300 children have been hospitalized and 94 have died from the disease to date are.
Members reviewed data from two studies conducted by Pfizer-BioNTech that included nearly 4,500 children. Overall, these studies showed that children who received the vaccine were less likely to contract COVID-19, and if they did, they were less likely to develop a serious illness or be hospitalized. There were no vaccine-related deaths in these studies.
These data had to be weighed against the known side effects of the vaccine, including Multisystem Inflammatory Syndrome in Children (MIS-C) – a rare condition that causes fever, loss of blood pressure, and damage to various organs including the liver – and myocarditis, an inflammation of the heart muscle . CDC scientists analyzed the rates of these complications in vaccinated children as well as those who developed COVID-19, and found that the risk of adverse events was higher in children infected with SARS-CoV-2 than in those who did have been vaccinated.
However, the CDC scientists and committee members acknowledged that due to the fact that younger children were not eligible for vaccination, not much data is available on risk in this population – the Pfizer BioNTech studies only included several thousand children. Nonetheless, Lynn Bahta, a member of the CDC panel, of the Minnesota Department of Health said, “We know more than what we don’t know. And we are very committed to closing these gaps. “
CDC officials noted that once the vaccine is rolled out to this population, the agency’s scientists will continue to monitor potential safety concerns through a number of different reporting systems, including those accessible to the public, such as a smartphone tool.
The CDC team also presented compelling models showing the impact vaccinating children could have on the burden of disease. For every million vaccinations in this age group, 18,000 cases of COVID-19, as well as 80 hospital admissions and 26 intensive care units, could be prevented, the team predicted. Compared to other vaccinations for children, a COVID-19 vaccination could prevent three times as many deaths as other vaccinations already given to children.
“When do you know enough? That is the question, “says Dr. Paul Offit, professor of pediatrics at Children’s Hospital of Philadelphia and a member of the FDA advisory committee who recommended the vaccine for children ages 5 to 11 knows enough? There is a huge platform with safety data from 16 to 17 year olds and also children over the age of 12, and that is a lot of information on the subject of safety. “
Even so, Offit says parents are more reluctant to vaccinate their children than to vaccinate themselves. The CDC team presented results from a survey that shows that only about half of parents with children in this age group said their child was definitely or likely get vaccinated. “We acknowledge that there are parents who have concerns about COVID-19 vaccines,” said Dr. Matthew Daley, senior investigator at Kaiser Permanente Colorado and a member of the CDC committee. “We hear you loud and clear and we know that you want the best for your child. And we encourage you to speak to your family doctor or pediatrician. ”He also encouraged doctors to work with parents to give families the information they need to make an informed decision about vaccinating their children.
The CDC will provide doctors with more detailed guidance on immunizing children who fall between the age groups for the two different doses. While 5 to 11 year olds receive a third of the adult dose, 12 to 15 year olds receive the full dose. For example, the agency will provide guidance on whether an 11-year-old who initially receives a smaller dose and then turns 12 before the second shot should receive a full dose. The experts found that the vaccine doses are given according to age and not according to height or weight.
The panel’s recommendation means that pediatricians and general practitioners will likely bear the brunt of the calls and questions from parents, as most families have indicated that these offices are where they want their children to be vaccinated. The Biden administration is ready to send cans directly to other medical practices in the coming weeks. Pediatric cans are labeled differently to distinguish them from adult cans, with orange-colored versus purple-colored caps.
“I’m doing this to prevent number 95, the 95th death,” said Veronica McNally, President and CEO of the Franny Strong Foundation and a member of the Consumer Protection Committee, explaining why she voted to recommend universal vaccination for 5 to 11 years got old. “To say that this disease does not affect children is not an accurate statement and I hope people understand that.”
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Reference: time.com
