FDA seeks approval for coronavirus vaccine for kids under 12
Fox News medical contributor Dr. Nicole Saphier speaks with concerned parents who are skeptical of vaccinating their young children
Parents should have the option to vaccinate their children when a vaccine becomes available. This is especially true for parents of kids with pre-existing medical conditions, including obesity.
As highlighted in a recent study from the Centers for Disease Control and Prevention (CDC), a real-world analysis of COVID-19 hospitalizations among adolescents aged 12–18 years showed 72 percent of those hospitalized had at least one underlying pre-existing medical condition. Of the hospitalized, 97 percent were unvaccinated, highlighting the importance of vaccinating high-risk adolescents.
PFIZER SAYS ITS COVID-19 VACCINE MORE THAN 90% EFFECTIVE IN KIDS
Late Friday evening, the U.S. Food and Drug Administration (FDA) published the clinical trial data on Pfizer/ BioNTech’s low dose, two-part vaccine for children ages 5-11 years, which their independent advisory committee is scheduled to meet soon to review. The CDC's own independent advisory committee will convene the following week and, if approved, the vaccine for this age group may be available at pediatricians' offices by Thanksgiving, according to the White House plan unveiled earlier this week.
Undoubtedly, the FDA will authorize the vaccine in this age group under the Emergency Use Authorization (EUA); there is little question of that, since even early data demonstrate an ability to mount an immune response to SARS-CoV-2. However, whether the CDC will recommend a universal vaccine should be thoroughly scrutinized as this age group has the lowest severity risk for COVID-19.
Worldwide data show the fatality rate in young kids (5-11 years) from COVID-19 is less than 0.008 percent. Of the over 650,000 Americans who have lost their lives from Covid, fewer than 160 have been in this age group. However, death is not the only metric when it comes to determining whether this population should be vaccinated under the EUA.
Hospitalization, persistence of symptoms for less than 6 months and post-infectious Multisystem Inflammatory Disorder in Children (MIS-C) should also be considered. Each having an estimated prevalence in this age group of less than 0.5 percent, two to five percent, and 0.2 percent respectively.
The fatality rate in young kids (5-11 years) from Covid-19 is less than 0.008 percent.
If Pfizer produces data demonstrating the vaccine further decreases the risk of severe and chronic outcomes without subjecting them to moderate to severe adverse effects, there is little reason not to recommend vaccination in this age group. Most common adverse reactions following the vaccine were reportedly mild local reactions with 12.5 percent having high fever (101 to less than 104 degrees) and nearly 69 percent of kids reporting fatigue following the second dose -- both which may keep the children out of school.
Such systemic reactions are often expected for vaccines so how much they interfere with daily activities, ability to attend school and hospital visits should be assessed compared to Covid-19 symptoms.
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In the recently released figures, Pfizer reports no cases of severe adverse effects of anaphylaxis, appendicitis, Bell’s palsy, myopericarditis, or MIS-C following vaccination. The data did report a single case of bilateral lower leg paresthesia (numbness/tingling) having resolved within a few days.
However, as we saw with adolescents and young adults, infrequent adverse events are not always captured in trials.
Because of the increased prevalence of post-vaccine myopericarditis in young adult and adolescent males as more of the population received the vaccine, albeit uncommon, places across the globe began offering alternative vaccine regimens. Such alternatives like, risk-based for those with chronic medical conditions, single doses, and even not recommending it in certain age groups.
Alternatively, the United States has been inflexible with its recommendations resulting in many states even mandating the vaccine for adolescents attending school. As we move forward with evaluating data for an even lower risk group, the U.S. ought to step outside its rigid all-or-none mentality when it comes to recommending the vaccine in kids 5 to 11. Their recommendations lead to mandates and this must be taken into consideration.
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Pfizer itself said, "The number of participants in the current clinical development program is too small to detect any potential risks of myocarditis associated with vaccination."
The CDC should consider the nominal risk to healthy young children from Covid-19 and the low sample size of patients in the clinical trial when determining who should be recommended for the vaccine. It is also prudent for the CDC acknowledge the upward of 8 to 10 million children who may have natural immunity from prior infection with nominal data proving clinical benefit in this age group of vaccination post infection.
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The data from Pfizer showed no cases of COVID-19 observed in either the vaccine or the placebo group in kids with evidence of prior infection. This should have been expanded upon to determine if there was a clinical benefit to vaccination post infection. Especially given the increasing data on natural immunity, including a Duke study showing even kids who had asymptomatic Covid-19 had robust antibody protection at least 4 months after infection.
Children have been burdened enough by top-down decisions not aligned with evidence-based research through the course of the pandemic. Any mandate that comes under the EUA for young kids will be in haste and have consequences.
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