FDA pushing vaccine boosters for infants based upon trials in just 24 children

(AP Photo/Andrew Harnik, File)

The FDA has approved the use of a new bivalent COVID-19 booster for children 6 months old to 4 years old based upon trials that included almost no children.

24 participants for the 6-month-23-month cohort, and 36 for the 2 years through 4 years old cohort. 60 children in all.

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I would love to meet the parents who agreed to the experiments being performed on their children to find out why they consented.

There are tens of millions of children in these age cohorts, and while this sort of trial is better than one where only 9 mice are given the jab, it strikes me as bizarre that the FDA is pushing this out the door and recommending that all children in America be vaccinated with a jab that has barely been tested.

Particularly given that the COVID virus presents almost no threat to any children those ages.

European countries have pulled back from recommending or even giving COVID vaccines to people under 50, except in cases where the patient is in a high-risk category. It beggars belief that the United States FDA is still going full steam ahead recommending vaccines that are not actually approved–they are being given under an Emergency Use Authorization, not full approval–to millions of children at little risk for serious disease.

Even the FDA admits that there are side effects, because of course there are. There are with everything. Side effects can be justified if the benefits outweigh the downsides, but there really is no evidence that the benefits are there.

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…among individuals 6 months of age and older, safety was assessed in participants in two clinical studies. In one study participants 6 months through 11 years of age who were previously vaccinated with a 3-dose primary series of monovalent Pfizer-BioNTech COVID-19 Vaccine received a booster dose of the Pfizer-BioNTech COVID 19 Vaccine, Bivalent. Among 24 participants 6 months through 23 months, the most common side effects included irritability, drowsiness, injection site redness, pain and swelling, decreased appetite, fatigue, and fever. Among 36 participants 2 years through 4 years of age, the most common side effects included fatigue, injection site pain, redness and swelling, diarrhea, vomiting, headache, joint pain, and chills.  Among 113 participants 5 through 11 years of age, the most common side effects included, fatigue, headache, muscle pain, joint pain, chills, fever, vomiting, diarrhea, injection site pain, swelling and redness, and swelling of the lymph nodes in the same arm of the injection. In another study, 316 participants 12 years of age and older who were previously vaccinated with a 2-dose primary series and a single booster dose of monovalent Pfizer-BioNTech COVID-19 Vaccine, received a second booster dose with the Pfizer BioNTech COVID-19 Vaccine, Bivalent. The most commonly reported side effects by the participants in this age group were the same as those reported by the participants in the 5 through 11 years age group.

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COVID-19 is not polio, for God’s sake. Young children are at almost no risk of severe disease, and we already have ample evidence that the vaccine is utterly ineffective at preventing infection. It can’t, because the infection takes place in the respiratory tract, and the vaccine only works once the virus invades the rest of the body. Which happens, but very rarely.

And more rarely still in young children. In 3 years 397 children 0-4 years old have died from COVID in the United States, and of those almost none of them have had serious underlying health conditions.

More than 90% of children have had COVID-19 at least once, according to the CDC, so what exactly is the point? Natural immunity is at least as good as vaccine-induced immunity, so this is all pain and no gain.

No matter. Vaccines have become a religious rite, not a public health tool.

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