FDA gave the booster (3d dose) for elementary school children its blessing today.
“On Jan. 3, the FDA authorized the use of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for administration to individuals 12 through 15 years of age
after completion of primary vaccination with the Pfizer-BioNTech
COVID-19 Vaccine. Today’s action expands the use of a single booster
dose of the vaccine for administration to individuals 5 through 11 years
age at least five months after completion of a primary series of the
Pfizer-BioNTech COVID-19 Vaccine. The FDA has authorized the
Pfizer-BioNTech COVID-19 Vaccine for use in individuals 5 years of age
and older and has approved Comirnaty (COVID-19 Vaccine, mRNA) for use in
individuals 16 years of age and older…
The FDA has determined that the known and potential benefits of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age at least five months after completing a primary series outweigh its known and potential risks and that a booster dose can help provide continued protection against COVID-19 in this and older age groups…
The FDA did not hold a meeting of its Vaccines and Related Biological Products Advisory Committee on today’s action, as the agency previously convened the committee for extensive discussions regarding the use of booster doses of COVID-19 vaccines and, after review of Pfizer’s EUA request, the FDA concluded that the request did not raise questions that would benefit from additional discussion by committee members…”
So, after the VRBPAC advisory committee agreed at its last meeting that approving a booster in the fall would require clinical trial data for efficacy since the antibody titers were not reliable, someone higher up than Peter Marks (Director of CBER, the FDA’s vaccine division) and Robert Califf (FDA Commissioner) gave the order to forget all that, and find a way to authorize another @!^&*$# dose.
Ignoring both a) its guidance for industry requirements for a COVID authorization, which had been pushed out over and over again over the past 2 years, and b) FDA’s recent statements at VRBPAC that actual clinical trial evidence of efficacy would be needed to authorize a booster in the fall, the FDA got the dirty job done, attributing its booster authorization for elementary scchoolchildren to “immunobridging” data and “safety” data in very small numbers of schoolchildren.
The extent of the farce of public health is hard for me to describe and comprehend. All standards have been tossed out, and all authorizations and approvals are now based on the flimsiest of pretenses. They are barely pretending. And to give a useless but dangerous shot to kids is pure evil. Why are they doing it? What is in the shots? Why is this travesty so important? Who is calling the shots? And when will the pitchforks come out?