FDA advisers endorse Covid-19 vaccine for kids 5-11 years old

The Centers for Disease Control and Prevention presented data showing that children aged 5-11 years old are "at least equally likely" to contract Covid-19. Surveillance testing also suggests that pediatric cases are often underreported. Children of color are three times more likely to be hospitalized than children of white, which highlights the racial disparities that can also be seen in adult patients.
Kathrin U. Jansen (Pfizer's senior vice-president and head of vaccine development and research) applauded this vote.

She stated that 10% of weekly U.S. cases are in children under 12 years old, with the potential for complications. "Immunizing children will also help us to reach herd immunity and stop the pandemic sooner.

A Friday FDA staff analysis concluded that the benefits of the product outweigh any potential side effects for children. The FDA staff analysis also indicated that the balance could be affected if Covid cases rates drop to June levels, depending on how many instances of myocarditis, an inflammatory heart condition, occur in this age group.

Based on modeling FDA data, agency representatives used a conservative estimate for myocarditis cases in 5-to-11-year-olds. This age group doesn't usually experience many of these conditions.

Nevertheless, panel members had reservations about recommending that the shot be given to children under the age of 5. This suggests that CDC's experts might consider limiting the eligibility population to those at greatest risk for complications.

Cody Meissner from Tufts University School of Medicine stated that the vaccine should be readily available to parents who are eager to have their child get it.

He said, "I'm worried that if the states say yes, that they will mandate administration of this vaccine for children to go to school. And I don't agree with that." "I believe that this would be an error until we have more information about safety.

Matthew Oster, a CDC Center on Birth Defects and Developmental Disabilities, stated that not all myocarditis cases will be the same. He noted that vaccine-induced myocarditis cases seem to heal faster than those caused either by viruses or multisystem inflammation syndrome (MIS-C) in children. To collect more information on the long-term effects, the agency is currently surveying myocarditis cases of patients who were reported to vaccine side effects registries.

Pfizer stated that no myocarditis cases were reported during pediatric clinical trials. Pfizer also stated that the FDA requested that its trial be doubled to ensure it could detect rare cases. More than 4,600 children were enrolled in the study. Of these, approximately 3,100 received the vaccine. The rest received a placebo.

Doctors routinely vaccinate their children against diseases that cause far fewer ICU admissions and deaths. Amanda Cohn, a CDC pediatrician, sits on an FDA panel.

She said that the benefit to me is obvious. "We don't want children dying from Covid, even though it is much less than for adults."

Cohn stated that the CDC's advisory panel could make "more focused or nuanced suggestions" about who in the 5--11-year-old age range should receive the vaccine. However, they couldn't go any further than what the FDA would eventually authorize for emergency use.

Children under 12 years old would receive 10-microgram doses of the vaccine. This is one-third of the doses given to teenagers and adults. Pfizer claims that the vaccine is almost 91 percent effective for this age group.

Pfizer was asked by panel members to consider two scenarios: whether older children should wait until they turn 12 to receive a higher dose of vaccine; and, conversely if a lower dose would still be effective for younger children.

Bill Gruber, Pfizer’s senior vice president for vaccine research and development, stated that the vaccine produced an identical antibody response in all age groups, despite a lower dose for younger children.

Gruber stated that Pfizer doesn't have data on the lower dose in an older population. However, he said that Pfizer was "considering this as a possible option" as the pandemic is over.


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