May 31, 2020 03:32 AM
(This post was last modified: May 31, 2020 03:56 AM by C C.)
Believing that we'll have a coronavirus vaccine anytime soon is naive at best
https://geneticliteracyproject.org/2020/...e-at-best/
EXCERPT: . . . Dr. Anthony Fauci [...] has put into perspective the overly optimistic predictions that a vaccine can be available even in the oft-cited target window of 12-18 months: “a vaccine that you make and start testing in a year is not a vaccine that’s deployable.” Even Mr. Slaoui, who is directing Warp Speed, conceded in an interview with the New York Times, that, “Frankly, 12-18 months is already a very aggressive timeline … I don’t think Dr. Fauci was wrong.”
Dr. Fauci is well aware of the complexity of vaccine development, testing, and approval—including the Food and Drug Administration’s mistake in approving a vaccine to prevent swine flu in the 1970s, which resulted in four hundred and fifty people developing a serious adverse reaction, the rare, paralytic Guillain-Barré syndrome. What made the situation even worse for regulators then is that the predicted epidemic never materialized, so the vaccine wasn’t even needed.
There are other potential safety issues, particularly with novel, unproven technologies—which, again, virtually all the COVID-19 candidate vaccines use. One potential problem was revealed in preclinical testing: they actually made the disease worse due to the induction of infection-enhancing antibodies in vaccinated animals, a phenomenon called antibody-dependent enhancement, which has also been seen in humans who have been infected with dengue virus.
Once burned, twice shy, the old saying goes, and regulators have a long memory, which is why the FDA’s regulation of vaccines is especially conservative for vaccines that would be administered to large numbers of healthy people. For example, before approval, the first successful rotavirus vaccine (RotaTeq) was tested on 72,000 healthy infants; the first human papillomavirus vaccine (Gardasil) on more than 24,000 people; and the newest shingles vaccine (Shingrix) on about 29,000 subjects. And the agency was woefully slow, lagging behind other countries, in approving the first vaccine against meningococcus B, a life-threatening bacterial infection.
Just planning and getting clinical trials of that magnitude underway for a potential COVID-19 vaccine is a major undertaking... (MORE - details)
RELATED: The man who beat the 1957 flu pandemic: Maurice Hilleman
Global survey finds that lots of people have weird digestive troubles
https://gizmodo.com/lots-of-people-have-...1843734048
EXCERPT: A substantial portion of the world’s population deals with chronic and mysterious digestive issues, the results of a large global survey indicate. [...] symptoms of a functional gastrointestinal disorder ... with “functional” meaning that their symptoms had no clear outside cause or mechanism.
The research project was funded and conducted by the Rome Foundation, a long-running nonprofit studying these functional gastrointestinal disorders, or FGIDs. FGIDs are defined as chronic health problems along the digestive system that aren’t detectable through a standard medical examination, such as through abnormal blood test results. Many FGIDS, like irritable bowel syndrome (IBS), are probably caused by a combination of complex but still unknown factors and can take years to be properly diagnosed. Often, these disorders are just as hard to treat as they are to diagnose.
[...] “It’s striking how similar the findings are between countries. We can see some variations but, in general, these disorders are equally common whatever the country or continent.” ... These disorders can run the gamut from being a persistent but mild annoyance to a debilitating condition. Overall, people with functional gastrointestinal disorders reported having a lower quality of life than those without one. They were also more likely to report needing to visit the doctor, take medication, and have surgery. Because of the lower positive rate among household interviews ... it’s also possible that many sufferers are ashamed to openly admit their symptoms, the authors said.
For many years, FGIDs and similarly mysterious ailments like chronic fatigue were often dismissed by doctors as being psychological in nature. [...] the study authors note that research into understanding and treating these ailments is still relatively limited. ... “Funding for research in the FGIDs is universally low, and they are viewed as a non-priority. The data highlight a strong need and rationale for this to change,” the authors wrote... (MORE - details)
https://geneticliteracyproject.org/2020/...e-at-best/
EXCERPT: . . . Dr. Anthony Fauci [...] has put into perspective the overly optimistic predictions that a vaccine can be available even in the oft-cited target window of 12-18 months: “a vaccine that you make and start testing in a year is not a vaccine that’s deployable.” Even Mr. Slaoui, who is directing Warp Speed, conceded in an interview with the New York Times, that, “Frankly, 12-18 months is already a very aggressive timeline … I don’t think Dr. Fauci was wrong.”
Dr. Fauci is well aware of the complexity of vaccine development, testing, and approval—including the Food and Drug Administration’s mistake in approving a vaccine to prevent swine flu in the 1970s, which resulted in four hundred and fifty people developing a serious adverse reaction, the rare, paralytic Guillain-Barré syndrome. What made the situation even worse for regulators then is that the predicted epidemic never materialized, so the vaccine wasn’t even needed.
There are other potential safety issues, particularly with novel, unproven technologies—which, again, virtually all the COVID-19 candidate vaccines use. One potential problem was revealed in preclinical testing: they actually made the disease worse due to the induction of infection-enhancing antibodies in vaccinated animals, a phenomenon called antibody-dependent enhancement, which has also been seen in humans who have been infected with dengue virus.
Once burned, twice shy, the old saying goes, and regulators have a long memory, which is why the FDA’s regulation of vaccines is especially conservative for vaccines that would be administered to large numbers of healthy people. For example, before approval, the first successful rotavirus vaccine (RotaTeq) was tested on 72,000 healthy infants; the first human papillomavirus vaccine (Gardasil) on more than 24,000 people; and the newest shingles vaccine (Shingrix) on about 29,000 subjects. And the agency was woefully slow, lagging behind other countries, in approving the first vaccine against meningococcus B, a life-threatening bacterial infection.
Just planning and getting clinical trials of that magnitude underway for a potential COVID-19 vaccine is a major undertaking... (MORE - details)
RELATED: The man who beat the 1957 flu pandemic: Maurice Hilleman
Global survey finds that lots of people have weird digestive troubles
https://gizmodo.com/lots-of-people-have-...1843734048
EXCERPT: A substantial portion of the world’s population deals with chronic and mysterious digestive issues, the results of a large global survey indicate. [...] symptoms of a functional gastrointestinal disorder ... with “functional” meaning that their symptoms had no clear outside cause or mechanism.
The research project was funded and conducted by the Rome Foundation, a long-running nonprofit studying these functional gastrointestinal disorders, or FGIDs. FGIDs are defined as chronic health problems along the digestive system that aren’t detectable through a standard medical examination, such as through abnormal blood test results. Many FGIDS, like irritable bowel syndrome (IBS), are probably caused by a combination of complex but still unknown factors and can take years to be properly diagnosed. Often, these disorders are just as hard to treat as they are to diagnose.
[...] “It’s striking how similar the findings are between countries. We can see some variations but, in general, these disorders are equally common whatever the country or continent.” ... These disorders can run the gamut from being a persistent but mild annoyance to a debilitating condition. Overall, people with functional gastrointestinal disorders reported having a lower quality of life than those without one. They were also more likely to report needing to visit the doctor, take medication, and have surgery. Because of the lower positive rate among household interviews ... it’s also possible that many sufferers are ashamed to openly admit their symptoms, the authors said.
For many years, FGIDs and similarly mysterious ailments like chronic fatigue were often dismissed by doctors as being psychological in nature. [...] the study authors note that research into understanding and treating these ailments is still relatively limited. ... “Funding for research in the FGIDs is universally low, and they are viewed as a non-priority. The data highlight a strong need and rationale for this to change,” the authors wrote... (MORE - details)