FDA clears Pfizer booster for 5-11 year olds without advisory panel approval

The US Food and Drug Administration (FDA) has authorised Pfizer’s COVID booster shot for children, modified emergency use authorisation (EUA) booster dose of the Pfizer-BioNTech COVID-19 vaccine for children 5 to 11 years of age.

The booster shot is 10 micrograms, which is the same dose for this age group in its primary series and one-third of that given to people 12 years and older. The decision will now go to the Centers for Disease Control and Prevention (CDC) for approval. On April 28, 2022, Moderna submitted an application to the emergency FDA, USA for its two-dose COVID-19 injection for children aged six months to under six years.

When it comes to COVID, public health officials have consistently downplayed and ignored natural immunity among children. However, 81 research shows that natural immunity to COVID is equal or superior to any “vaccine immunity”.

Research shows that there is no benefit to children who receive a COVID injection and, in fact, the injections can cause harm, adverse effects and death.

According to Pfizer studies there is data proving that the likelihood of death in children from the shot is 107 times higher than death from COVID.

In fact, the CDC recently reported higher rates of COVID-19 cases among fully vaccinated children than unvaccinated children in the 5-11 age group since February 2022.

That is the first time CDC has recorded a higher case rate among fully vaccinated young children since data were first collected in December 2021. In addition, the Office for National Statistics revealed that children are up to 52 times more likely to die after the COVID-19 injection than children who have not received it.

In December 2021, the Office for National Statistics (ONS) has published a dataset containing details of ‘deaths by vaccination status in England’ per 100,000 people between 1 January 2021 and 31 October 2021.

The data revealed that vaccinated children aged 10-14 were statistically 10 times more likely to die than unvaccinated children, and vaccinated adolescents aged 15-19 were statistically twice as likely to die as unvaccinated adolescents.

However, the ONS data also show that during that time period, adolescents aged 15-19 who received two injections of COVID were statistically three times more likely to die than adolescents who were not vaccinated.

Scientific studies show that children have a very low risk of becoming seriously ill or dying from COVID or infecting other children, or adults as seen in family transmission studies.

According to a report from Yale University in 2020, scientists have observed that children fare much better than adults and have very diverse and different immune system responses to SARS-CoV-2 infection and have much less illness or mortality from COVID.

Studies by Ankit B Patel and Dr Supinda Bunyavanich show that the virus has limited expression and presence in the upper respiratory area in young children. This partly explains why children are less likely to become infected in the first place, or to transmit it to other children or adults, or even to become seriously ill.

Research published in August 2021 by J. Loske also revealed that “airway immune cells in children are primed for virus detection, resulting in a stronger early innate antiviral response to SARS-CoV-2 infection than in adults”.

On the FDA and its apparent complicity with the labs

The US Food and Drug Administration (FDA) cleared the booster dose of the Pfizer-BioNTech COVID-19 injection for children aged 5-11 years, without convening its independent expert vaccine advisory panel of experts to discuss Pfizer’s data in children aged 5-11 years. and based on a study subset of only 67 children, CNBC reported. However, a subset of only 67 children is not large enough to detect possible adverse events such as myocarditis , and it is unknown how quickly any protection provided fades because trial participants were not followed beyond a 28-day period.

No hay estudios que prueben la eficacia de la vacuna contra el BA.2 dominante actual COVID -19 variante y dos nuevos estudios que muestran que para las personas vacunadas que reciben Omicron, la infección brinda una mejor protección contra futuras infecciones que una segunda dosis de refuerzo.

El Dr. Peter Marks, director del Centro de Evaluación e Investigación Biológica de la FDA, dijo que los datos muestran cada vez más que la protección proporcionada por dos inyecciones disminuyen con el tiempo , pero la agencia supone sin base científica que una tercera inyección podría ayudar a aumentar la protección para los niños en el grupo de edad de 5 a 11 años.

La eficacia de la vacuna COVID de Pfizer disminuye rápidamente
Un estudio publicado el 13 de mayo en el Journal of the American Medical Association (JAMA) encontró que la protección de la vacuna COVID-19 de Pfizer se volvió negativamente efectiva entre niños y adolescentes cinco meses después de recibir una segunda dosis, lo que significa que los receptores tenían más probabilidades de contraer COVID-19 cinco meses después de haber sido vacunado. La efectividad de la vacuna “ya no fue significativamente diferente de 0 durante el mes 3 después de la segunda dosis”, escribieron los investigadores. También encontraron que la protección contra la hospitalización disminuyó significativamente con el tiempo.

Un estudio de preimpresión publicado en febrero mostró que el régimen de dos dosis de Pfizer de su vacuna COVID-19 para niños fue solo un 12% efectivo contra Omicron en niños de 9 a 11 años, y la efectividad de la vacuna «disminuyó rápidamente» para niños de 5 a 11.

El Dr. Peter Marks, principal funcionario de vacunas de la FDA le dijo a un comité del Congreso el 6 de mayo que las vacunas COVID-19 para niños menores de 6 años no tendrán que alcanzar el umbral de eficacia del 50% requerido por la agencia para obtener la EUA.


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