The Briefing Room
General Category => Health/Education => Topic started by: mountaineer on August 28, 2022, 11:11:28 pm
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Omicron Boosters Are Coming, But They Weren’t Tested on People. Here’s What You Need to Know
By Alice Park
August 26, 2022 10:15 AM EDT
TIME MagazineWith nearly all the new COVID-19 infections in the U.S. coming from the Omicron BA.4 and BA.5 subvariants, it makes sense that health officials are considering switching to a different vaccine to protect the public.
White House COVID-19 response coordinator Dr. Ashish Jha expects the first Omicron-specific booster to be available in mid-September at the earliest, if the U.S. Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) authorize and recommend the shot. In late August, both Pfizer-BioNTech and Moderna submitted requests to the FDA for authorization of their Omicron-specific boosters. ...
Back in June, the FDA’s panel of independent vaccine experts met to consider switching the country to a new booster that targets Omicron, given how quickly that variant is dominating new infections. ...
They asked the vaccine manufacturers to develop a new vaccine, one that combined the original vaccine and also targeted Omicron BA.4 and BA.5. At the end of August, both companies submitted data on their new, bivalent vaccines to the FDA for emergency use authorization.
Given the short time they had to develop the shot, however, the data only included information on the safety and efficacy of the booster in animals. Human studies are planned and will be ongoing even if the FDA and CDC decide to authorize the shots and the government starts distributing them. The FDA has also decided to review the animal study data without consulting its advisory committee again. ...
Rest of story at TIME (https://time.com/6208623/omicron-boosters-animals-clinical-trials/)
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Here's what you need to know: RESIST!!!
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OH HELL NO!
THAT's what I need to know... :whistle:
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Tell the government "NO!" to their "request" for uninformed consent.
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Ain't NO F'king way!
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Ain't NO F'king way!
Me neither. I already had it -fought it off, and felt better in four days.
People need to figure out that our government, as presently constituted is far more dangerous than Covid-19 ever was.
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They dragged their feet for almost a year after this variant exploded and never even ran human tests to see if it worked?
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How many times in the history of the FDA has it approved a drug with little animal testing and no human testing?
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No thanks.
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Latest Covid Boosters Are Set to Roll Out Before Human Testing Is Completed
The FDA and vaccine makers say they are confident that shots targeting Omicron subvariants will work safely
By Liz Essley Whyte
Aug. 28, 2022 5:30 am ET
The Food and Drug Administration is expected to authorize new Covid-19 booster shots this week without a staple of its normal decision-making process: data from a study showing whether the shots were safe and worked in humans.
The shots, modified to target the latest versions of the Omicron variant, won’t have finished testing in humans when the FDA makes its decisions.
Instead, the agency plans to assess the shots using data from other sources such as research in mice, the profiles of the original vaccines and the performance of earlier iterations of boosters targeting older forms of Omicron.
“Real world evidence from the current mRNA Covid-19 vaccines, which have been administered to millions of individuals, show us that the vaccines are safe,” FDA Commissioner Robert Califf said in a recent tweet. The FDA pointed to Dr. Califf’s tweets when asked for comment.
Clearance of the doses, without data from human testing known as clinical trials, is similar to the approach the FDA takes with flu shots, which are updated annually to keep up with mutating flu viruses.
more
https://www.wsj.com/articles/latest-covid-boosters-are-set-to-roll-out-before-human-testing-is-completed-11661679003?mod=djemalertNEWS
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!!BIG NEWS!!
!!!FDA authorizes Pfizer's and Moderna's updated Covid booster shots!!!
https://www.nbcnews.com/health/health-news/fda-authorizes-pfizers-modernas-updated-covid-booster-shots-rcna44825
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As I became a Sr., I have been pretty dilligent about getting flu shots.
Got to wonder after this COVID debacle, how effective and safe they are too. The CDC and FDA have zero credibility, and trustworthiness.