Posted on 09/15/2021 9:44:40 PM PDT by SeekAndFind
The staff of the Food and Drug Administration on Wednesday declined to take a stance on whether to back booster shots of Pfizer’s Covid-19 vaccine, saying U.S. regulators haven’t verified all the available data.
“There are many potentially relevant studies, but FDA has not independently reviewed or verified the underlying data or their conclusions,” they wrote in a 23-page document published on the agency’s website. “Some of these studies, including data from the vaccination program in Israel, will be summarized during the September 17, 2021 VRBPAC meeting.”
The staff said some observational studies have suggested declining efficacy of the Pfizer vaccine over time against symptomatic infection or against the delta variant, while others have not.
“Overall, data indicate that currently US-licensed or authorized COVID-19 vaccines still afford protection against severe COVID-19 disease and death in the United States,” they wrote.
The data the FDA is looking at includes efficacy numbers out of Israel, where researchers there have released observational studies showing the effectiveness of the Pfizer vaccine against infection waned over time.
In separate documents released Wednesday, Pfizer argued a third dose of the Covid vaccine six months after a second shot restores protection from infection to 95%.
FDA staff appeared to take a skeptical tone on the data, as observational studies don’t adhere to the same standards as formal clinical trials.
“It should be recognized that while observational studies can enable understanding of real-world effectiveness, there are known and unknown biases that can affect their reliability,” agency staff said. “Furthermore, US-based studies of post-authorization effectiveness of BNT162b2 may most accurately represent vaccine effectiveness in the US population.”
(Excerpt) Read more at cnbc.com ...
Natural immunity is far superior to vaccine generated immunity...
RE: Natural immunity is far superior to vaccine generated immunity...
We all know this, but to attain natural immunity, you have to risk being exposed or infected by the Coronavirus.
Good… the FDA is doing its job in this instance. I’m not sure that Prfizer’s vaccine is losing some of its efficacy because of the lapse of time or just because it’s simply not as effective against the Delta variant. The Mayo Clinic study showed that the Pfizer vaccine was 42% effective (compared to unvaccinated individuals) at preventing detectable infections once Delta became dominant while Moderna still retained 76% efficacy in the same time period. That might mean that Pfizer is simply less effective against Delta regardless of the recency of vaccination so a third shot might not offer much improvement.
Fortunately both vaccines continue to offer good protection against Delta when it comes to hospitalization and death.
▁ ▂ ▄ ▅ ▆ ▇ █ [G̲̅][o̲̅][o̲̅][d̲̅] [f̲̅][o̲̅][r̲̅] [T̲̅][h̲̅][e̲̅][e̲̅] [B̲̅][u̲̅][t̲̅] [n̲̅][o̲̅][t̲̅] [f̲̅][o̲̅][r̲̅] [M̲̅][e̲̅][~̲̅][!̲̅] █ ▇ ▆ ▅ ▄ ▂ ▁
Didn’t they go forward with unverified data before?]
Actually, they don’t. Every day I read some horror story of what all these shots do to people
Who can say? You said something, but it carries no weight, as far as I’m concerned. Plenty of people are dead who’ve been injected. Plenty of people have recovered who have not. The kill-rate of the disease is low, and it certainly depends on the care received. Statements like yours can be easily made and mean nothing.
This is not a “vaccine”. It does not do anything the Polio vaccine did, and those behind it have changed the definition of “vaccine” to pretend that it is one.
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