FDA and CDC Encourage All Individuals to Go Get The 5th Shot Despite Lack of Data on Its Efficacy or Safety.
These emergency authorizations of Pfizer’s and Moderna’s bivalent boosters are based upon preliminary test findings from just eight mice, and those results haven’t even been made public yet.
A brief overview of the plot:
The emergency authorization of Pfizer’s and Moderna’s bivalent CV boosters is based on initial testing results from the grand total of eight mice, and those data haven’t even been made public yet. Pfizer is the company that developed the bivalent COVID-19 booster. Moderna is the company that developed the bivalent COVID-19 booster.
In light of the antibody response shown in eight mice, the administration of Joe Biden has placed an order for 171 million doses of two boosters.
A reanalysis of the data obtained from the COVID-19 vaccination trials conducted by Pfizer and Moderna revealed that the injections, when combined, were related to an increase in the risk of significant adverse outcomes of special interest at the level of 12.5 in 10,000 people who were vaccinated. In the meanwhile, the risk decrease for hospitalization in the COVID-19 study was just 2.3 per every 10,000 individuals for Pfizer vs 6.4 per 10,000 individuals for Moderna.
According to a new risk-benefit study of the third boost for university students, the booster will cause anywhere from 18 to 98 major adverse events for every COVID-19 hospitalization by using the booster.
It has been reported that a number of high-ranking officials at the NIH, the (CDC), and the Food and Drug Agency (FDA) of the United States have serious concerns about the path that we are taking, but they are unable to voice their opinions or provide resistance.
On August 31, the Food and Drug Administration (FDA) gave its approval for the repackaged COVID-19 bivalent vaccinations that were developed by Pfizer and Moderna. This authorization was granted despite the fact that the FDA did not convene its Inoculations and Related Biomedical Product lines Advisory Panel (VRBPAC), which is normally convened to discuss and vote on the acceptance of a new vaccine.
The Wallstreet Journal said.
Instead, the FDA brought the issue before the Immunization Practices Advisory Committee or ACIP, which is part of the Centers for Disease Control and Prevention.
The ACIP had a meeting on September 1 that lasted for eight hours and ultimately voted 13 to 1 to allow the untested boosters.
Later on that evening, Dr. Rochelle Walensky, director of the CDC, gave her approval to the suggestion.
The new booster developed by Pfizer is a bivalent injectable that targets Omicron subvariants BA.4 & BA.5, which are the two that are presently in circulation. It has been approved for use by anyone aged 12 and older.
The Moderna vaccine, which may only be administered to those older than 18 and is restricted to adults exclusively, is designed to eradicate the Wuhan strain of the Omicron subvariant BA.1.
Those who have previously gotten the initial two-dose regimen and/or a monovalent booster at least two months prior to receiving either of the 2 bivalent boosters are the only ones who are eligible to get them.
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