FDA officials predicted a major COVID-19 outbreak will occur in the US autumn. Manufacturers will have to race to produce the rebranded, experimental boosters by fall, The New York Times reported. The new image of the deadly mRNA ‘vaccines’ with more untested ingredients ensures multi billion dollar profits worldwide and slots into the mandates of the WHO’s Great Reset agenda
Info from Megan Redshaw | The Defender | June 29, 2022 via thefreeonline
Multiple concerns raised during the public comment session
“The proposed move by VRBPAC will increase the harm to the U.S. public to unprecedented levels, as this action will further circumvent necessary clinical trials even beyond the slapdash testing of COVID-19 vaccines under Emergency Use Authorization.
“This adds to a foundation of lies used to authorize the original COVID-19 vaccines without anywhere near proper testing.”
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“All the risks are to the innocent children and all of the billion-dollar rewards go to the government-protected pharmaceuticals,” said Rep. Louie Gohmert (R-Texas)
Michael Briskin pointed out in his public comment that the FDA receives approximately 75% of its budget from pharmaceutical companies, which he believes represents a conflict of interest.
The U.S. Food and Drug Administration’s (FDA) vaccine advisory panel on Tuesday voted 19 to 2 to recommend without further testing new COVID-19 booster shots that include the Omicron variant this fall.
The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) did not issue guidance on whether additional data would be needed to recommend an updated composition of the primary-series vaccines authorized for emergency use in the U.S., or whether it would be appropriate to continue to use a primary-series vaccine as a booster…..
It is the first time VRBPAC has suggested vaccine makers modify their vaccines to target a different variant, according to CNBC, which also reported the FDA will likely accept the committee’s recommendation.
If so, the FDA would be authorizing a vaccine change without requiring additional data showing a bivalent vaccine — containing both the original 2019 Wuhan variant and one of the Omicron variants — is safe and effective for those age groups that are already authorized to receive a booster dose.
The FDA plans to decide by early July whether vaccines will target the now-dominant BA.4 and BA.5 Omicron subvariants or the BA.1 Omicron variant that led to a surge in infections last winter, Reuters reported.
At the beginning of the meeting, Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, suggested a newly designed shot could begin in October, adding that it takes manufacturers around three months to choose a vaccine design and begin producing doses.
Dr. Paul Offit, director of the Vaccine Education Center and professor of pediatrics in the Division of Infectious Diseases at Children’s Hospital of Philadelphia, and Dr. Hank Bernstein, professor of pediatrics at Zucker School of Medicine, were the only two members who broke from the panel to vote against the initiative.
Offit acknowledged there’s a benefit to providing a booster in the fall to some age groups, but questioned whether Omicron was the right strain. He said the move to new-variant vaccines was happening too fast, with too little data.
“I think as a new product it should be handled as a new product,” Offit said. “I think we need a higher standard than what we’ve been given. …“I’m not comfortable enough to support the risk of a new product.”
Bernstein expressed concern over the lack of data used to justify changing the strain, and the potential that by the time a subsequent booster is approved, it will contain outdated strains.
“So, in sum, I think including an Omicron strain in the vaccine seems to have some potential, but data especially for BA.4 and BA.5 are limited at this time, and that’s why I’m struggling to even make a strain change at this time,” Bernstein said.
Continue reading “Endemic Corruption: FDA Panel Votes to Drop Clinical Trials for New COVID Boosters to multiply Pharma profits”
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