Just In: FDA Panel Rejects Pfizer Booster Shot for Ages 16-65 Over Increased Risk of Heart Inflammation
On Friday, Biden’s vaccination plan hit a major roadblock after an FDA advisory panel declined to endorse authorization the Pfizer-BioNTech Covid booster shot for people aged 16 or older.
The 18 member group of influential experts was tasked with deciding if Pfizer’s latest clinical trials had provided adequate results that demonstrate the safety and effectiveness of their booster shot.
Unsurprisingly, the results did not make the cut, not even close.
The panel voted 16-2 to reject extra doses of experimental vaccine, citing insufficient data from incomplete clinical trials and the potential risk of heart inflammation – especially among young men.
The panel did, however, vote unanimously to endorse the booster for people aged 65 or older and “high-risk” individuals
“[The FDA Panel] endorsed emergency approval for the Pfizer-BioNTech COVID-19 vaccine booster shot at least six months following the second dose among people ages 65 and older and those at high risk of occupational exposure and severe COVID-19.
The meeting included members of the FDA’s Vaccines and Related Biological Products Advisory Committee, (VRBPAC), as well as officials from the Centers for Disease Control and Prevention (CDC), lsrael’s Health Ministry, vaccine experts and Pfizer representatives.”
The panel’s vote will now be weighed by the FDA to make a final decision on who will be eligible for the Pfizer booster.
The additional doses are being pushed because the original vaccine effectiveness has been fading quickly over time. Several studies have shown that people who have gotten the virus and then recovered – leaving them with natural immunity – are much better protected than those who are relying on the Pfizer jab.
In fact, one study that was conducted on 800,000 individuals showed that people who have taken both doses of the Pfizer jab are 13 TIMES more likely to have a breakthrough infection, and are at a “greater risk for Covid-19 hospitalizations.”
So much for the ‘pandemic of the unvaccinated’..
The US health regime and Big Pharma have cleverly used the poor vaccine results to push another round of experimental shots. They have begun to acknowledge the decline in protection against infection, but refuse to mention anything about natural immunity and downplay the adverse reactions that have been well documented.
Fox News: Dr. William Gruber, senior vice president of vaccine clinical research and development at Pfizer, noted Phase 3 trial data indicating waning protection over time, from 96% vaccine efficacy within two months after the second dose to about 84% by six months and amid the dominant delta variant.
Additional data suggested a third Pfizer dose would ramp up protection on par or better than the second dose, however concerns were raised over the potential increased risk of myocarditis. The FDA panel’s review included Pfizer’s trial results with some 300 participants ages 18-55 who received a booster dose about six months after the second dose.
The FDA will review the committees vote and is expected to issue a final decision on Pfizer’s booster sometime next week.
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