New COVID boosters approved for children without testing
FDA granted EUA for Pfizer booster dose of Pfizer/BioNTech bivalent COVID-19 shot for children 5 through 11 years of age, even though the companies have not completed proper trials. Surprised?
Yesterday, Pfizer Inc. and BioNTech announced that the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for a booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 shot for children 5 through 11 years of age, even though the companies have not completed the proper trials.
For each of the bivalent COVID-19 vaccines authorized today, the FDA relied on immune response and safety data that it had previously evaluated from a clinical study in adults of a booster dose of a bivalent COVID-19 vaccine that contained a component of the original strain of SARS-CoV-2 and a component of omicron lineage BA.1. The FDA considers such data as relevant and supportive of vaccines containing a component of the omicron variant BA.4 and BA.5 lineages. In addition, the FDA has evaluated and considered immune response and safety data from clinical studies of the monovalent mRNA COVID-19 vaccines, including as a booster dose in pediatric age groups. These data and real-world experience with the monovalent mRNA COVID-19 vaccines, which have been administered to millions of people, including young children, support the EUA of the bivalent COVID-19 vaccines in younger age groups.
Statement by the FDA
In other words, no testing on children was done with any bivalent booster.
In August, the FDA announced “the Moderna COVID-19 Vaccine, Bivalent, is authorized for use as a single booster dose in individuals 18 years of age and older. The Pfizer-BioNTech COVID-19 Vaccine, Bivalent, is authorized for use as a single booster dose in individuals 12 years of age and older.”
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The FDA authorized those boosters that target the BA.4 and BA.5 Omicron subvariants without complete data on how the shots performed in humans, claiming that it has enough alternate data to ensure safety. Instead, the agency is using data from other sources such as research in mice and data from the BA.1 human trials. In fact, eight mice were given the BA.5 booster dose about 100 days after receiving two doses of Pfizer’s original shot. In addition to authorizing the boosters without clinical-trial data, the FDA is also bypassing the typical protocol of earlier COVID shot reviews and not having a meeting of advisers who make recommendations whether the agency should authorize a shot.
However, the FDA still insists that the COVID shots are safe and effective.
When it comes to COVID, public health officials have consistently downplayed and ignored natural immunity among children. Yet 81 research studies confirm that natural immunity to COVID is equal or superior to any “vaccine immunity.”
Research shows that there is no benefit to children receiving a COVID shot, and in fact, the shots can cause potential harm, adverse effects and death. According to Pfizer’s own study trial data, the chance of death in children from the shot is 107 times higher than death from COVID.
In fact, the CDC recently reported higher COVID-19 case rates have been recorded among fully vaccinated children than unvaccinated in the age group 5-11 since Feb. 2022. That’s the first time CDC recorded a higher case rate among fully vaccinated young children since data was first collected in December 2021.
In addition, the Office for National Statistics revealed that children are up to 52 times more likely to die following the COVID-19 injection than children who have not received it. In Dec. 2021, the Office for National Statistics (ONS) published a dataset containing details on “deaths by vaccination status in England” per 100,000 people between Jan. 1, 2021 and Oct. 31, 2021. The data revealed that vaccinated children aged 10-14 were statistically 10 times more likely to die than unvaccinated children, and vaccinated teenagers aged 15-19 were statistically two times more likely to die than unvaccinated teenagers.
However, the ONS data also shows during that time period, teenagers aged 15-19 who had two COVID shots were statistically three times more likely to die than teenagers who were not vaccinated. Children aged 10-14 who were double vaccinated were statistically 52 times more likely to die than unvaccinated children.
Our precious children should not be the guinea pigs of pharmaceutical companies. Children are the least likely population to be adversely affected by COVID. Pharmaceutical companies merely see children as a budget item to increase their bottom line and they continue to ignore the serious adverse events and deaths caused by these experimental genetic shots. Instead of being the watchdog for the public, the FDA and the CDC have become the lap dogs for the pharmaceutical industry.
Mat Staver, Founder and Chairman, Liberty Counsel
Update: Hours after the FDA authorization, the Centers for Disease Control and Prevention (CDC) announced that children as young as 6 can now receive the Moderna vaccine booster, while children as young as 5 can now receive the Pfizer vaccine booster.